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Molar Distalizing Assembly

by American Orthodontics

510(k) K912417

Molar Distalizing Assembly is a Class I device made by American Orthodontics, cleared under FDA 510(k) K912417 on 20 Dec 1991, 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 NumberK912417 Date20 Dec 1991ClearedStatusActive

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  • Withdrawn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
DYJ
Device class
Class I
Regulation
21 CFR Part 872.5410
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code DYJ (Retainer, Screw Expansion, Orthodontic).

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