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Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive

by Ormco Corporation

510(k) K250015

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250015 Date3 Jan 2025ClearedStatusActive

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  • Withdrawn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
Device class
Class II
Regulation
21 CFR Part 872.3750
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

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

Cites

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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ormco EtchFree Bonding System is a dental adhesive system comprising the EtchFree Bonding Primer and EtchFree Adhesive. It is designed for orthodontic applications and eliminates the need for acid etching, providing complete moisture tolerance during bonding procedures.

The system is supplied as a set of components for use in orthodontic bonding. It is classified as a Class II medical device under FDA regulation number 872.3750 and has received FDA 510(k) clearance (K250015) as substantially equivalent to a predicate device.

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