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Brasseler USA 5000916U0

by Peter Brasseler Holdings, LLC

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 Number00887919404071 UDI-DI Date20 Apr 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  • Withdrawn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
Brasseler USA
Generic Name
Diamond dental bur, single-use
Model / Ref / Catalog
5000916U0
Description
A303RED ALUM FG 15HOLE 1P
Primary DI / UDI-DI
00887919404071
510(k) Number
FDA Product Code
FRG
GMDN Term
Diamond dental bur, single-use
Device Class
Class II
Regulation Number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K983223)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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