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Wax Disk Α

by Yamahachi Dental Mfg., Co. 4 variants

Ref 1PCS,20MM*95MM,GRAY, 1PC,14MM*98.5MM,GRAY, 1PCS,15MM*95MM,GRAY, 1PC,20MM*98.5MM,GRAY, 1PC,22MM*98.5MM,GRAY, 1PC,10MM*98.5MM,GRAY, 1PCS,18MM*95MM,GRAY, 1PC,15MM*98.5MM,GRAY, 1PC,12MM*98.5MM,GRAY

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D08016189CW9LH Basic UDI-DI Date24 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberXXWDA95MM20GRY UDI-DI Date5 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  • Withdrawn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 casting wax
Device Name
Wax Disk
Model / Reference
1PCS, 20MM*95MM, GRAY, 1PC, 14MM*98.5MM, 15MM*95MM, 20MM*98.5MM, 22MM*98.5MM, 10MM*98.5MM, 18MM*95MM, 15MM*98.5MM, 12MM*98.5MM
Primary DI / UDI-DI
XXWDA95MM20GRY EUDAMED
XXWDA985M14GRY EUDAMED
XXWDA95MM15GRY EUDAMED
XXWDA985M20GRY EUDAMED
XXWDA985M22GRY EUDAMED
XXWDA985M10GRY EUDAMED
XXWDA95MM18GRY EUDAMED
XXWDA985M15GRY EUDAMED
XXWDA985M12GRY EUDAMED
D080XXWDA985M22GRY0 GUDID
D080XXWDA985M14GRY0 GUDID
D080XXWDA985M10GRY0 GUDID
D080XXWDA985M12GRY0 GUDID
D080XXWDA985M15GRY0 GUDID
D080XXWDA985M20GRY0 GUDID
Basic UDI-DI
++D08016189CW9LH
FDA Product Code
EGD
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental casting wax
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
XXWDA95MM20GRY
XXWDA985M14GRY
XXWDA95MM15GRY
XXWDA985M20GRY
XXWDA985M22GRY
XXWDA985M10GRY
XXWDA95MM18GRY
XXWDA985M15GRY
XXWDA985M12GRY
GUDID
D080XXWDA985M22GRY0
D080XXWDA985M14GRY0
D080XXWDA985M10GRY0
D080XXWDA985M12GRY0
D080XXWDA985M15GRY0
D080XXWDA985M20GRY0

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