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Coldpac Tooth Acylic Powder

by Yates Motloid division of Bird-X, Inc. 2 variants

Ref TP0159

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

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 Number706069ToothAcylicPowderZC Basic UDI-DI 00706069311117UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00706069311117 UDI-DI Date26 Aug 2016ListedStatusListed GUDID: 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  • Withdrawn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
Coldpac Tooth Acylic Powder EUDAMED
Yates Motloid Coldpac Tooth Acrylic GUDID
Generic Name
Temporary dental crown/bridge
Model / Reference
TP0159
Primary DI / UDI-DI
00706069311117
Basic UDI-DI
706069ToothAcylicPowderZC
Direct Marketing DI
00706069311117
FDA Product Code
EBG
EMDN Code
Q0102050101 Temporary teeth resins
GMDN Term
Temporary dental crown/bridge
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3770
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.0625 Pound

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000052564
Authorised representative
ALTRION IT-AR-000050286

From the manufacturer

Manufacturer's product page: Coldpac Tooth Acrylic Kit from $163.90

Other devices from Yates Motloid division of Bird-X, Inc.

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No