Cleared Traditional

Orthocem, Ortho Bite

K192682 · Dentscare Ltda · Dental
Aug 2020
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K192682 is an FDA 510(k) clearance for the Orthocem, Ortho Bite, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on August 14, 2020, 323 days after receiving the submission on September 26, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K192682 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2019
Decision Date August 14, 2020
Days to Decision 323 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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