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AuraVeneer Cement Off White

by Denali Corporation

AuraVeneer Cement Off White (AVOW) is a dental composite resin (FDA Class II; FDA product code EMA, Cement, Dental) made by Denali Corporation, listed in FDA GUDID since 4 Aug 2016 (UDI-DI D820AVOW), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD820AVOW UDI-DI Date4 Aug 2016ListedStatusListed 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  • Withdrawn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
AuraVeneer Cement
Generic name
Dental composite resin
Model / Ref / Catalog
Off White, AVOW
Primary DI / UDI-DI
D820AVOW
FDA product code
EMA
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

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Other devices filed under Dental composite resin.

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Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)