Skip to content

Ormco System 1+ (Tm)

by Ormco Corporation

510(k) K941015

Ormco System 1+ (Tm) is a Class II device made by Ormco Corporation, cleared under FDA 510(k) K941015 on 31 Mar 1994, 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 NumberK941015 Date31 Mar 1994ClearedStatusActive

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  • Withdrawn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
DYH
FDA applicant
Ormco Corp.
Device class
Class II
Regulation
21 CFR Part 872.3750
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices from Ormco Corporation

See all devices from Ormco Corporation →