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Enamel Pro® Prophy Paste 9007607

by Premier Dental Products Company

Part of a family of 26 devices: see the family page

Ref 9007607

Enamel Pro Prophy Paste 9007607 is a dentifrice (EU MDR Class I; FDA Class I; FDA product code EJR, Agent, Polishing, Abrasive, Oral Cavity) made by Premier Dental Products Company, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 00348783EnamelProPPasteJ3), cleared under FDA 510(k) K062166 on 21 Nov 2006 and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 00348783005325), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K062166

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783EnamelProPPasteJ3 Basic UDI-DI 00348783005325UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783005325 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062166 Date21 Nov 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00348783EnamelProPPasteJ3 registered 1 Jun 2026 Active
  • FDA 510(k) K062166 decided 21 Nov 2006 Active
  • FDA GUDID UDI-DI 00348783005325 listed 29 Jun 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062166
  2. Listed FDA GUDID 00348783005325
  3. Registered EUDAMED 00348783EnamelProPPasteJ3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Enamel Pro® Prophy Paste Strawberry-Fine (Box of 200) EUDAMED
Enamel Pro® Prophy Paste GUDID
Generic name
Dentifrice
Model / reference
9007607
Primary DI / UDI-DI
00348783005325
Basic UDI-DI
00348783EnamelProPPasteJ3
510(k) Number
FDA product code
EJR
EMDN code
Q010502 Dental polishing cups, single-use
GMDN term
Dentifrice
Device class
Class I
Regulation number
872.6030
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dentifrice

Cleared under the same submission (K062166)

and 8 more cleared under K062166

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTISTRY, SINGLE-USE.

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)