Skip to content

Edenta BF11-100

by Edenta Etablissement

Edenta BF11-100 is a Class I device made by Edenta Etablissement, listed in FDA GUDID since 3 Feb 2022 (UDI-DI E312BF111001), 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 NumberE312BF111001 UDI-DI Date3 Feb 2022ListedStatusListed 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  • Withdrawn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
Edenta
Generic name
Dental abrasive point, reusable
Model / reference
BF11-100
Primary DI / UDI-DI
E312BF111001
FDA product code
EJQ
GMDN term
Dental abrasive point, reusable
Device class
Class I
Regulation number
872.6010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental abrasive point, reusable

Similar devices in this category

Other devices filed under Dental abrasive point, reusable.

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)