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We Hereby Declare That The Above-Mentioned Device(s) Comply With Council Directive 93/42/EEC

This document is an Annex V EC Declaration of Conformity for Premise Flowable dental materials made by Kerr Corporation. It declares that the products comply with the European Medical Device Directive and have received a CE Certificate (Number 00847) after assessment by Notified Body BSI Group The Netherlands B.V. under the production quality assurance procedure. An attachment lists the specific product references covered by this declaration.

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35 views

We Hereby Declare That The Above-Mentioned Device(s) Comply With Council Directive 93/42/EEC

This document is an Annex V EC Declaration of Conformity for Premise Flowable dental materials made by Kerr Corporation. It declares that the products comply with the European Medical Device Directive and have received a CE Certificate (Number 00847) after assessment by Notified Body BSI Group The Netherlands B.V. under the production quality assurance procedure. An attachment lists the specific product references covered by this declaration.

Uploaded by

Ramy Amir
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Annex V EC Declaration of Conformity

Manufacturer Name and Kerr Corporation


Address: 1717 W. Collins Ave.,
Orange, CA 92867, USA

Authorized Representative Name Kerr Italia S.r.l.


and Address: Via Passanti, 174
Scafati (SA) 84018, Italy

Technical File Name/Number: Premise Flowable Technical File, R094

Product Tradename(s): Premise Flowable

Device Identification: See Attachment 1

Classification and Rule(s): IIa per Annex IX, Rule 8

Notified Body: BSI Group The Netherlands B.V.


Notified Body Number: 2797
Conformity Assessment Annex V – Production Quality Assurance
Procedure & Certificate Issued: CE Certificate Number 00847

Declaration Statement:
We hereby declare that the above-mentioned device(s) comply with Council Directive 93/42/EEC.

Regulatory Affairs Signature:

22 October 2021
Issue date Name:: M ark Dzendzel
Mark
Title: Director, Quality Assurance Systems

DC MP 30-47 Appendix X
Rev.15 Page 1 of 2
Premise Flowable – Attachment 1
to Annex V EC Declaration of Conformity

REF Description
33371 Premise Flowable Assorted Kit
33372 PremIse Flowable 4 PK Syringes, A1
33373 Premise Flowable 4 PK Syirnges, A2
33374 Premise Flowable 4 PK Syirnges, A3
33375 Premise Flowable 4 PK Syirnges, A3.5
33376 Premise Flowable 4 PK Syirnges, B1
33385 Premise Flowable 4 PK Syirnges, B2
33377 Premise Flowable 4 PK Syirnges, C2
33378 Premise Flowable 4 PK Syirnges, Universal Opaque
33379 Premise Flowable 4 PK Syirnges, XL1
33380 Premise Flowable 4 PK Syirnges, XL2
33721 Premise Flowable Syringe, A1
33722 Premise Flowable Syringe, A2
33723 Premise Flowable Syringe, A3
33724 Premise Flowable Syringe, A3.5
33725 Premise Flowable Syringe, B1
33726 Premise Flowable Syringe, B2
33727 Premise Flowable Syringe, C2
33728 Premise Flowable Syringe, Universal Opaque
33729 Premise Flowable Syringe, XL1
33730 Premise Flowable Syringe, XL2

DC MP 30-47 Appendix X
Rev.15 Page 2 of 2

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