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Orthodontic Plastic Bracket

by American Orthodontics

510(k) K891372

Orthodontic Plastic Bracket is a Class II device made by American Orthodontics, cleared under FDA 510(k) K891372 on 31 Mar 1989, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891372 Date31 Mar 1989ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DYW
Device class
Class II
Regulation
21 CFR Part 872.5470
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

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