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Bite Tray 9048076

by Premier Dental Products Company

Ref 9048076

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783BiteTray82 Basic UDI-DI 00348783012026UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783012026 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Posterior Bite Tray – Box of 50 EUDAMED
Bite Tray GUDID
Generic Name
Dental impression tray, single-use
Model / Reference
9048076
Primary DI / UDI-DI
00348783012026 EUDAMED
D6919048076 GUDID
Basic UDI-DI
00348783BiteTray82
FDA Product Code
EHY
EMDN Code
Q010503 Impression material trays, single-use
GMDN Term
Dental impression tray, single-use
Device Class
Class I
Regulation Number
872.6880
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00348783012026
GUDID
D6919048076

Related devices

Category: Dental impression tray, single-use

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No