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VITA VIONIC® BASE RESIN FLEX pink transparent 1000g 04634

by DETAX GmbH

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 NumberEDET046341 UDI-DI Date4 Feb 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  • Withdrawn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
VITA VIONIC® BASE RESIN FLEX pink transparent 1000g
Generic Name
Denture reliner, elastic, long-term
Model / Reference
04634
Primary DI / UDI-DI
EDET046341
510(k) Number
FDA Product Code
EBI
GMDN Term
Denture reliner, elastic, long-term
Device Class
Class II
Regulation Number
872.3760
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K252430)

Other devices from DETAX GmbH

See all devices from DETAX GmbH →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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