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DentaFab R01-NC-04-OM3

by 3BFAB Teknoloji Anonim Sirketi

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08685313736208 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DentaFab
Generic Name
Dental appliance fabrication material, resin
Model / Reference
R01-NC-04-OM3
Primary DI / UDI-DI
08685313736208
510(k) Number
FDA Product Code
EBF, EBI, PZY
GMDN Term
Dental appliance fabrication material, resin
Device Class
Class II
Regulation Number
872.3690, 872.3760, 872.3590
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K262681)

Show all (12)

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Properties

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

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No