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Re-Fine Bright

by Yamahachi Dental Mfg., Co. 54 variants

Ref 15G,LF PINK

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-XXRFBX15GXXLFP Basic UDI-DI XXRFBX15GXXLFPUDI-DIDate7 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberXXRFBX15GXXLFP UDI-DI Date4 Oct 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Dental prosthesis restorative material, unfilled resin
Model / Reference
15G, LF PINK
Primary DI / UDI-DI
XXRFBX15GXXLFP EUDAMED
D080XXRFBX15GXXLFP0 GUDID
Basic UDI-DI
B-XXRFBX15GXXLFP
510(k) Number
FDA Product Code
EBI
EMDN Code
Q0102050101 Temporary teeth resins
GMDN Term
Dental prosthesis restorative material, unfilled resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3760
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
XXRFBX15GXXLFP
GUDID
D080XXRFBX15GXXLFP0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Dental appliance fabrication material, resin

Other devices from Yamahachi Dental Mfg., Co.

See all devices from Yamahachi Dental Mfg., Co. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No