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Diamond Wedge Long Extra Large

by Bioclear Matrix Systems LLC 3 variants

Diamond Wedge Long Extra Large is a Class I device made by Bioclear Matrix Systems LLC, listed in FDA GUDID since 15 Aug 2023 (UDI-DI D949112091501), 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 NumberD949112091501 UDI-DI Date15 Aug 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  • Withdrawn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
Diamond Wedge
Generic name
Dental wedge, single-use
Model / reference
Long Extra Large
Primary DI / UDI-DI
D949112091501
FDA product code
EJB
GMDN term
Dental wedge, single-use
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
Other properties (13, all answered No)