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Paraffin Wax

by Yamahachi Dental Mfg., Co. 26 variants

Ref 5LBS,LARGE MEDIUM,PINK, 5LBS,SOFT,LIGHT PINK, 1KG,LARGE MEDIUM,CLEAR, 1KG,LARGE SOFT,LIGHT PINK, 5LBS,LARGE MEDIUM,LIGHT PINK, 500G,SOFT,LIGHT PINK, 1KG,LARGE MEDIUM,PINK, 500G,MEDIUM,CLEAR, 5LBS,MEDIUM,CLEAR, SAMPLE,LARGE MEDIUM,LIGHT PINK, 500G,LARGE SOFT,CLEAR, 1KG,LARGE SOFT,PINK, SAMPLE,MEDIUM,PINK, 5LBS,LARGE SOFT,PINK, 500G,MEDIUM,PINK, 500G,LARGE SOFT,PINK, SAMPLE,LARGE SOFT,PINK, SAMPLE,MEDIUM,CLEAR, 5LBS,MEDIUM,LIGHT PINK, 5LBS,SOFT,CLEAR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D08034808WX9PQ Basic UDI-DI Date6 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberXXPRW5LBSLMPNK UDI-DI Date2 Oct 2023ListedStatusListed 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  • Withdrawn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

Generic Name
Dental base plate
Device Name
Bite Rim Stick, Paraffin Wax
Model / Reference
5LBS, LARGE MEDIUM, PINK, SOFT, LIGHT PINK, 1KG, CLEAR, LARGE SOFT, 500G, MEDIUM, SAMPLE
Primary DI / UDI-DI
XXPRW5LBSLMPNK EUDAMED
XXPRW5LBSSOLGP EUDAMED
XXPRWX1KGLMCLE EUDAMED
XXPRWX1KGLSLGP EUDAMED
XXPRW5LBSLMLGP EUDAMED
XXPRW500GSOLGP EUDAMED
XXPRWX1KGLMPNK EUDAMED
XXPRW500GMDCLE EUDAMED
XXPRW5LBSMDCLE EUDAMED
XXPRWSAMPLMLGP EUDAMED
XXPRW500GLSCLE EUDAMED
XXPRWX1KGLSPNK EUDAMED
XXPRWSAMPMDPNK EUDAMED
XXPRW5LBSLSPNK EUDAMED
XXPRW500GMDPNK EUDAMED
XXPRW500GLSPNK EUDAMED
XXPRWSAMPLSPNK EUDAMED
XXPRWSAMPMDCLE EUDAMED
XXPRW5LBSMDLGP EUDAMED
XXPRW5LBSSOCLE EUDAMED
D080XXPRW5LBSLSPNK0 GUDID
D080XXPRWX1KGLMCLE0 GUDID
D080XXPRW5LBSMDCLE0 GUDID
D080XXPRW500GMDPNK0 GUDID
D080XXPRWSAMPLSPNK0 GUDID
D080XXPRW500GLSPNK0 GUDID
D080XXPRWX1KGLSLGP0 GUDID
D080XXPRW5LBSLMLGP0 GUDID
D080XXPRWSAMPLMLGP0 GUDID
D080XXPRW500GLSCLE0 GUDID
D080XXPRWSAMPMDPNK0 GUDID
D080XXPRWSAMPMDCLE0 GUDID
D080XXPRW5LBSSOLGP0 GUDID
D080XXPRWX1KGLMPNK0 GUDID
D080XXPRW5LBSSOCLE0 GUDID
D080XXPRW500GSOLGP0 GUDID
D080XXPRW5LBSLMPNK0 GUDID
D080XXPRWX1KGLSPNK0 GUDID
D080XXPRW500GMDCLE0 GUDID
D080XXPRW5LBSMDLGP0 GUDID
Basic UDI-DI
++D08034808WX9PQ
FDA Product Code
EGD
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental base plate
Device Class
Class I
Regulation Number
872.6890
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
XXPRW5LBSLMPNK
XXPRW5LBSSOLGP
XXPRWX1KGLMCLE
XXPRWX1KGLSLGP
XXPRW5LBSLMLGP
XXPRW500GSOLGP
XXPRWX1KGLMPNK
XXPRW500GMDCLE
XXPRW5LBSMDCLE
XXPRWSAMPLMLGP
XXPRW500GLSCLE
XXPRWX1KGLSPNK
XXPRWSAMPMDPNK
XXPRW5LBSLSPNK
XXPRW500GMDPNK
XXPRW500GLSPNK
XXPRWSAMPLSPNK
XXPRWSAMPMDCLE
XXPRW5LBSMDLGP
XXPRW5LBSSOCLE
GUDID
D080XXPRW5LBSLSPNK0
D080XXPRWX1KGLMCLE0
D080XXPRW5LBSMDCLE0
D080XXPRW500GMDPNK0
D080XXPRWSAMPLSPNK0
D080XXPRW500GLSPNK0
D080XXPRWX1KGLSLGP0
D080XXPRW5LBSLMLGP0
D080XXPRWSAMPLMLGP0
D080XXPRW500GLSCLE0
D080XXPRWSAMPMDPNK0
D080XXPRWSAMPMDCLE0
D080XXPRW5LBSSOLGP0
D080XXPRWX1KGLMPNK0
D080XXPRW5LBSSOCLE0
D080XXPRW500GSOLGP0
D080XXPRW5LBSLMPNK0
D080XXPRWX1KGLSPNK0
D080XXPRW500GMDCLE0
D080XXPRW5LBSMDLGP0

Manufacturer details

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

Other devices from Yamahachi Dental Mfg., Co.

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

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No