Cleared Traditional

SOLO ORTHO 3

K020502 · Sybron Dental Specialties, Inc. · Dental
May 2002
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K020502 is an FDA 510(k) clearance for the SOLO ORTHO 3, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on May 1, 2002, 76 days after receiving the submission on February 14, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K020502 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2002
Decision Date May 01, 2002
Days to Decision 76 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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