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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 the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2018-01-17 under 510(k) 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. The listed applicant is Pulpdent Corporation. The 510(k) number is K173020.

When did OBA-MCP, Orthodontic Bracket Adhesive with MCP receive FDA 510(k) clearance?

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

Who is the listed applicant for OBA-MCP, Orthodontic Bracket Adhesive with MCP?

The FDA 510(k) record lists Pulpdent Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07291830A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket BondingNOT_YET_RECRUITINGNCT07517601Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical TrialACTIVE_NOT_RECRUITING

Other records listing Pulpdent Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210045ACTIVA PRESTO PACKK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPK153249Pulpdent Solo Flowable Composite with MCP

Related Devices (Code: DYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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