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Premier Retraction Cap 9048260

by Premier Dental Products Company

Ref 9048260

Premier Retraction Cap 9048260 is a gingival retraction cord (EU MDR Class I; FDA Class I; FDA product code NYF, Gingival Retraction Kit) made by Premier Dental Products Company, registered in EUDAMED on 29 May 2026 (Basic UDI-DI 00348783RetractionCapA2) and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 00348783003659), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783RetractionCapA2 Basic UDI-DI 00348783003659UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783003659 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00348783RetractionCapA2 registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00348783003659 listed 29 Jun 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00348783003659
  2. Registered EUDAMED 00348783RetractionCapA2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Assorted Retraction Caps 15 - #1- 15 - #3, 30 - #5 EUDAMED
Premier Retraction Cap GUDID
Generic name
Gingival retraction cord, non-medicated
Model / reference
9048260
Primary DI / UDI-DI
00348783003659
Basic UDI-DI
00348783RetractionCapA2
FDA product code
NYF
EMDN code
Q019004 Dental cotton rolls
GMDN term
Gingival retraction cord, non-medicated
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gingival retraction cord, non-medicated

Similar devices in this category

Other devices filed under DENTAL DEVICES - VARIOUS.

Other devices from Premier Dental Products Company

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)