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FDA 510(k)

OBA-MCP, Orthodontic Bracket Adhesive with MCP

K-Number: K173020 · 2018-01-17

ApplicantPulpdent Corporation
Decision Date2018-01-17
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBA-MCP, Orthodontic Bracket Adhesive with MCP is a medical device manufactured by Pulpdent Corporation. It received FDA 510(k) clearance on 2018-01-17 under approval number K173020. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBA-MCP, Orthodontic Bracket Adhesive with MCP?

OBA-MCP, Orthodontic Bracket Adhesive with MCP is a medical device that received FDA 510(k) clearance on 2018-01-17. It is manufactured by Pulpdent Corporation. The 510(k) number is K173020.

When was OBA-MCP, Orthodontic Bracket Adhesive with MCP approved by the FDA?

OBA-MCP, Orthodontic Bracket Adhesive with MCP received FDA 510(k) clearance on 2018-01-17, under approval number K173020.

What company makes OBA-MCP, Orthodontic Bracket Adhesive with MCP?

OBA-MCP, Orthodontic Bracket Adhesive with MCP is manufactured by Pulpdent Corporation.

What is the FDA product code for OBA-MCP, Orthodontic Bracket Adhesive with MCP?

The FDA product code for OBA-MCP, Orthodontic Bracket Adhesive with MCP is DYH.

Related Clinical Trials

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Other Devices by Pulpdent Corporation

K153249Pulpdent Solo Flowable Composite with MCP K172169Pulpdent (Activa) Pit and Fissure Sealant with MCP K210045ACTIVA PRESTO PACK

Related Devices (Code: DYH)

K160782BracePaste AdhesiveAmerican Orthodontics K161684Quantum LBReliance Orthodontic Products, Inc. K183147BrackFixVoco GmbH K192682Orthocem, Ortho BiteDentscare Ltda K202276BracePaste Band and Build LCAmerican Orthodontics K193388GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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