Cleared Traditional

OBA-MCP, Orthodontic Bracket Adhesive with MCP

K173020 · Pulpdent Corporation · Dental
Jan 2018
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K173020 is an FDA 510(k) clearance for the OBA-MCP, Orthodontic Bracket Adhesive with MCP, a Adhesive, Bracket And Tooth Conditioner, Resin (Class II — Special Controls, product code DYH), submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on January 17, 2018, 111 days after receiving the submission on September 28, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3750.

Submission Details

510(k) Number K173020 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2017
Decision Date January 17, 2018
Days to Decision 111 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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