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NextDent NDOF01000_US

by Vertex-Dental B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number08719425509556 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
NextDent
Generic Name
Dental appliance fabrication material, resin
Model / Reference
NDOF01000_US
Primary DI / UDI-DI
08719425509556
FDA Product Code
MQC, KMY
GMDN Term
Dental appliance fabrication material, resin
Device Class
U
Regulation Number
872.5525
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental appliance fabrication material, resin

Other devices from Vertex-Dental B.V.

See all devices from Vertex-Dental B.V. →

Properties

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

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No