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Biotec Control Unit

by Biotec, Inc.

Biotec Control Unit is a Class I device made by Biotec, Inc., listed in FDA GUDID since 18 Jan 2024 (UDI-DI 00860011235002), 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 Number00860011235002 UDI-DI Date18 Jan 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Biotec
Generic name
Dental delivery system instrument unit, pneumatic
Model / reference
Control Unit
Primary DI / UDI-DI
00860011235002
FDA product code
EIA
GMDN term
Dental delivery system instrument unit, pneumatic
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental delivery system instrument unit, pneumatic

Similar devices

Other devices filed under FDA product code EIA (Unit, Operative Dental).

Properties

  • Premarket exempt
Other properties (14, all answered No)