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American Medicals 1

by American Medicals 1,000+ variants

American Medicals 1 is a Class I device made by American Medicals, listed in FDA GUDID since 15 Apr 2026 (UDI-DI B356KF251040), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB356KF251040 UDI-DI Date15 Apr 2026ListedStatusListed 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  • Withdrawn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
American Medicals
Generic name
Dental material application tool, reusable
Model / reference
1
Primary DI / UDI-DI
B356KF251040
FDA product code
MDM
GMDN term
Dental material application tool, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Microwave Radiation

Other devices from American Medicals

See all devices from American Medicals →

Properties

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