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Alpen RU10169L

by Coltene/Whaledent Inc.

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 NumberD661RU10169L1 UDI-DI Date11 Feb 2019ListedStatusListed 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  • Withdrawn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
Alpen
Generic name
Carbide dental bur, reusable
Model / reference
RU10169L
Primary DI / UDI-DI
D661RU10169L1
FDA product code
EJL
GMDN term
Carbide dental bur, reusable
Device class
Class I
Regulation number
872.3240
GUDID distribution status
In Commercial Distribution

Related devices

Category: Carbide dental bur, reusable

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No