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Damon 4CLEAR

by Ormco Corporation

510(k) K081415

Damon 4CLEAR is a medical device (FDA Class II; FDA product code NJM, Bracket, Ceramic, Orthodontic) made by Ormco Corporation, cleared under FDA 510(k) K081415 on 24 Sep 2008, 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 NumberK081415 Date24 Sep 2008ClearedStatusActive

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  • Withdrawn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
NJM
FDA applicant
Ormco Corp.
Device class
Class II
Regulation
21 CFR Part 872.5470
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

Similar devices

Other devices filed under FDA product code NJM (Bracket, Ceramic, Orthodontic).

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