DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
ATTESTATION / CERTIFICATE N° 9101 rev. 12
Délivrée à Paris le 27 avril 2020
Issued in Paris on April 27th, 2020
ATTESTATION CE / EC CERTIFICATE
Approbation du Système Complet d'assurance Qualité/ Approval of full Quality Assurance System
ANNEXE II excluant le point 4 Directive 93/42/CEE relative aux dispositifs médicaux
ANNEX II excluding section 4 Directive 93/42/EEC concerning medical devices
Pour les dispositifs de classe III, un certificat CE de conception est requis
For class III devices, a EC design certificate is required
Fabricant / Manufacturer
PULPDENT CORPORATION
80 Oakland Street
WATERTOWN, MA 02472 UNITED STATES
Catégorie du(des) dispositif(s) / Device(s) category
Dispositifs médicaux à usage professionnel dentaire
(Cf. Addendum pour description complète de la catégorie)
Medical devices for professional dental use
(see Addendum for additional information)
Voir détails sur addendum / See attachment for additional information
GMED atteste qu'à l'examen des résultats figurant dans le rapport référencé T000231-1-R, T000550-2-DOCR, le système
d'assurance qualité - pour la conception, la production et le contrôle final - des dispositifs médicaux énumérés ci-dessus est
conforme aux exigences de l'annexe II excluant le point 4 de la Directive 93/42/CEE.
GMED certifies that, on the basis of the results contained in the file referenced T000231-1-R, T000550-2-DOCR, the quality system - for
design, manufacturing, and final inspection - of medical devices listed here above complies with the requirements of the Directive
93/42/EEC, annex II excluding section 4
La validité du présent certificat est soumise à une vérification périodique ou imprévue
The validity of the certificate is subject to periodic or unexpected verification
Début de validité / Effective date : April 27th, 2020 (included)
Valable jusqu'au / Expiry date : July 27th, 2020 (included)
GMED_b2p3-F-V0-07-2018
On behalf of the President
GMED - 9101 rev. 12 Béatrice LYS
Modifie le certificat 9101-11 Technical Director
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 1/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Catégorie des dispositifs (Description complète)
Device category (Full Description)
Dispositifs médicaux à usage professionnel dentaire: adhésifs dentaires, produits pour
préparation des surfaces, produits pour comblement des puits et fissures, ciment verre ionomère et
résine composite, produit pour le coiffage pulpaire, produits de comblement de fond de cavité et de
canal radiculaire (non-médicinaux), pansements parodontaux, matériaux pour couronnes et bridges
temporaires et matériaux fluorés et de reminéralisation
Medical devices for professional dental use: dental adhesives, surface preparation
materials, pit and fissure sealants, glass ionomer and resin composite materials, pulp capping
materials, cavity liners and root canal sealant (non-medicated), periodontal dressings, temporary
crown and bridge materials and cements, and fluoride and remineralization materials
Identification des dispositifs / Identification of devices
Classe du
Référence Commerciale du Dispositif
Dispositif
Description du Dispositif Médical Médical
Médical
Medical Device Description Medical Device Commercial Reference
Medical Device
Number
Class
ACTIVA BioACTIVE-BASE/LINER VB1, VB2, S-VB, VTB1, VTB2, S-VTB IIa
ACTIVA BioACTIVE-CEMENT VC1A2, VC2A2, VC1T, VC2T, S-VCA2,
S-VCT
IIa
VTC1A2, VTC2A2, VTC1T, VTC2T,
S-VTCA2, S-VTCT
ACTIVA BioACTIVE-RESTORATIVE VRA1, VRA2, VRA3, VR1A1, VR1A2, VR1A3,
VR1A35, VR2A1, VR2A2, VR2A3, VR2A35,
S-VRA2
IIa
VTRA1, VTRA2, VTRA3, VTR1A1, VTR1A2,
VTR1A3, VTR1A35, VTR2A1, VTR2A3,
VTR2A2, VTR2A35
ACTIVA KIDS BioACTIVE-RESTORATIVE VKP, VK1P, VK2P, VTK1P, VTK2P, VTKP IIa
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 2/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Classe du
Référence Commerciale du Dispositif
Dispositif
Description du Dispositif Médical Médical
Médical
Medical Device Description Medical Device Commercial Reference
Medical Device
Number
Class
ACTIVA PRESTO VPF1A1, VPF1A2, VPF1A3, VPF1A35,
VPF1A4, VPF1A6, VPF1B1, VPF1BL,
VPF1BW, VPF1OS
VPF3A1, VPF3A2, VPF3A3, VPF3A35,
VPF3A4, VPF3A6, VPF3B1, VPF3BL,
VPF3BW, VPF3OS
IIa
S-VPFA1, S-VPFA2, S-VPFA3, S-VPFA35,
S-VPFA4, S-VPFA6, S-VPFB1, S-VPFBL,
S-VPFBW, S-VPFOS
VPFCA1, VPFCA2, VPFCA3, VPFCA35,
VPFCA4, VPFCA6, VPFCB1, VPFCBW,
VPFCOS
ACTIVA PRONTO VNF1A1, VNF1A2, VNF1A3, VNF1A35,
VNF1A4, VNF1A6, VNF1B1, VNF1BL,
VNF1BW, VNF1OS
VNF3A1, VNF3A2, VNF3A3, VNF3A35,
VNF3A4, VNF3A6, VNF3B1, VNF3BL,
VNF3BW, VNF3OS
S-VNFA1, S-VNFA2, S-VNFA3, S-VNFA35, IIa
S-VNFA4, S-VNFA6, S-VNFB1, S-VNFBL,
S-VNFBW, S-VNFOS
VNFCA1, VNFCA2, VNFCA3, VPNCA35,
VNFCA4, VNFCA6, VNFCB1, VNFCBW,
VNFCOS
DenTASTIC Dental Adhesive System DAS-C1, DASP-A, DASP-B, DASP-C, DASP-1,
IIa
DASP-2, CDUR, CDURE
DenTASTIC DUO Dual Cure Catalyst for UNO DUO, CDDUO, CDDUOE IIa
DenTASTIC UNO Single Component Dental Adhesive UNO, UNO-R, S-UNO, CDUNO, CDUNOE IIa
DenTASTIC UNO-DUO UNDO IIa
Dentin Conditioning Gel DEN IIa
Dentin Desensitizer DES IIa
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 3/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Classe du
Référence Commerciale du Dispositif
Dispositif
Description du Dispositif Médical Médical
Médical
Medical Device Description Medical Device Commercial Reference
Medical Device
Number
Class
EDTA Solution, 17% EDTA-30, EDTA-60, EDTA-120, EDTA480 IIa
Embrace Esthetic Opaquer EMO1, EMO2, EMO3 EMO4, EMO5, E4200 IIa
Embrace Varnish FV50, FV200, FVT, FVX100, S-FV, ZG-FV1 IIa
Embrace Wet Bond Pit & Fissure Sealant, Natural Shade EMS, EMS3, EMSB, S-EMS, E2000, E2100 IIa
Embrace Wet Bond Pit & Fissure Sealant, Off-white Shade EMSW, EMSW3, EMSWB, S-EMSW, E2200,
IIa
E2300
Embrace WetBond Class V Cervical Restorative Resin EMVA2, EMVA35, E5100, E5400 IIa
Embrace WetBond First Coat EMFC, E4100 IIa
Embrace WetBond Low Fill Pit & Fissure Sealant EMSWLF, EMSWLFB IIa
Embrace WetBond Resin Cement / Low Viscosity EMCA, EMCAR, EMCAR2, E1000, E1100,
IIa
E1200
Embrace WetBond Resin Cement / Medium Viscosity EMCM, EMCMR, EMCMR2, E1300, E1400,
IIa
E1500, ACEM7, F67000
Embrace WetBond Restoration & PFM Repair Kit EMPFM, E4000 IIa
Embrace WetBond Seal-n-Shine EMSNS, EMSNY, S-EMSNS, E3000, E3100 IIa
Etch Royale 37% Phosphoric Acid Etching Gel ER, ER6, ER24, ER50, ER50R, S-ER IIa
Etch-All 10 % Phosphoric Acid Etching Gel EA, EA-5 IIa
Etch-Rite 38% Phosphoric Acid Etching Gel ETCH, ET-TWIN, ET-6, ET-12, ET12G, ET-24,
ET-144, ET-50, ET-50R, S-ETCH IIa
ET12-TOP, ET50-TOP, ET4-TOP
File-Rite EDTA Gel FILE, S-FILE, FILET
IIa
EDTA-THV, EDTA-TLV
Flows-Rite, Multi-Purpose Flowable Composite and Veneer FK1, FKA1, FKA2, FKA3, FKA35, FKS,
IIa
Cement
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 4/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Classe du
Référence Commerciale du Dispositif
Dispositif
Description du Dispositif Médical Médical
Médical
Medical Device Description Medical Device Commercial Reference
Medical Device
Number
Class
S-FLOWS
Forendo Paste FORE IIa
GlassFill Glass Ionomer Filling Material IFU IIa
GlassLine Glass Ionomer Lining Material & Post Cement ILI IIa
GlassLute Glass Ionomer Cement ILU IIa
Kleer Veneer KV1, KV2, KV4 IIa
Lime-Lite Enhanced, Light Cure Cavity Liner LLE, LLE3, S-LLE IIa
Multi-Cal MULTI, MULTI-3, S-MULTI, MULTI-TOP IIa
Opaquer OP1, OP2 IIa
Ortho-Choice Glass Ionomer Band Cement OCGI IIa
Ortho-Choice OBA Bonding Resin OCBAR IIa
Ortho-Choice Ortho-Coat OC IIa
Ortho-Choice Orthodontic Bracket Adhesive (OBA) OCBA, OCBAS IIa
PerioCare Periodontal Dressing PC IIa
PolyCarb WaterSet, Anhydrous Polycarboxylate Cement CPC IIa
Porcelain Prep Kit PPK IIa
Prep-Rite RC / Viscous EDTA Gel PRC, APRC, B58000 IIa
Pressure Syringe Combo Kit (includes RK) PSK IIa
Pulpdent Cavity Liner PCL, PCL-I IIa
Pulpdent Paste PSYK, PSY, E1300 IIa
Pulpdent Root Canal Sealer Endodontic Filling Material RK, RSP, RSP-4, RSL, RSL-2, RK-I IIa
Seal-Rite Low Viscosity Pit and Fissure Sealant SEAL-LV IIa
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 5/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Classe du
Référence Commerciale du Dispositif
Dispositif
Description du Dispositif Médical Médical
Médical
Medical Device Description Medical Device Commercial Reference
Medical Device
Number
Class
Seal-Rite Pit & Fissure Sealant SEAL, SEAL-3, RITE, S-SEAL IIa
Semi-Gel Etchant 35 % Phosphoric Acid ET-18 IIa
Silane Bond Enhancer SIL, SIL-3, SIL-TOP, E1400 IIa
SNOOP Caries Disclosing Agent SNOOP IIa
Spee-Dee Build-Up SBU50, SBU, SBU5, SBUAP, SBUAP3, E7000
IIa
F80680, F80682, F80686
TempCanal Enhanced TEK, TE3, TE4, S-TEK IIa
Tuff-Temp™ Plus Provisional Veneer, Crown & Bridge TTPA1, TTPA2, TTPA3, TTPA35, TTPB1,
Resin TTPB, TTP5A1, TTP5A2, TTP5A3, TTP5A35,
TTP5B1, TTP5B, TTG, S-TTPA3
TTP50A1, TTP50A2, TTP50A3, IIa
TTP50A1X, TTP50A2X, TTP50A3X
TTA2AP, TTA3AP
F67300, F67310
Ce certificat couvre les sites suivants / This certificate covers the following sites:
Pulpdent Corporation
80 Oakland Street
Watertown, MA 02472 USA
Activités effectuées en ce site / Activities performed on this site:
Conception, fabrication et contrôle final / Design, manufacturing and final control
Pulpdent Corporation
73 Oakland Street
Watertown, MA 02472 USA
Activités effectuées en ce site / Activities performed on this site:
Fabrication / Manufacturing
****
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
DocuSign Envelope ID: A1A12BA4-3C1D-4D54-9787-D9A579B2FFC4
Addendum au certificat n° 9101 rev. 12 page 6/6
Addendum of the certificate n° 9101 rev. 12
Dossier / File N° T000231-1-R, T000550-2-DOCR
Pulpdent Corporation
46 Acton Street
Watertown, MA 02472 USA
Activités effectuées en ce site / Activities performed on this site:
Fabrication / Manufacturing
****
Pulpdent Corporation
300-304 Pleasant Street
Watertown, MA 02472 USA
Activités effectuées en ce site / Activities performed on this site:
Fabrication / Manufacturing
****************
4 sites / 4 sites
GMED 0459
On behalf of the President
Béatrice LYS
Technical Director
ADD - 720 DM 0701-31 rev 6 du 01/08/2018
