Cleared Traditional

D3 CHROMA

K042422 · Sybron Dental Specialties, Inc. · Dental
Nov 2004
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K042422 is an FDA 510(k) clearance for the D3 CHROMA, 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 November 15, 2004, 69 days after receiving the submission on September 7, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K042422 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2004
Decision Date November 15, 2004
Days to Decision 69 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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