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OptraSculpt Starter Kit 683067AN

by Ivoclar Vivadent Aktiengesellschaft

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberDVIV683067AN1 UDI-DI Date26 Aug 2020ListedStatusListed 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  • Withdrawn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
OptraSculpt Starter Kit
Generic Name
Dental restoration carver, resin
Model / Ref / Catalog
683067AN
Primary DI / UDI-DI
DVIV683067AN1
FDA Product Code
DZN
GMDN Term
Dental restoration carver, resin
Device Class
Class I
Regulation Number
872.4565
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental restoration carver, resin

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Properties

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

Other properties (10)

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