Cleared Traditional

Ormco? EtchFree Bonding System, Ormco? EtchFree Bonding Primer, Ormco? EtchFree Adhesive

K250015 · Ormco Corporation · Dental
Jan 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K250015 is an FDA 510(k) clearance for the Ormco? EtchFree Bonding System, Ormco? EtchFree Bonding Primer, Ormco? EtchFree Adhesive, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Ormco Corporation (Brea, US). The FDA issued a Cleared decision on January 3, 2025, 1 days after receiving the submission on January 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K250015 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2025
Decision Date January 03, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DYH — Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3750

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