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FDA 510(k)

ORTHOJOIN, ORTHODONTIC ADHESIVE

K-Number: K861118 · 1986-05-02

ApplicantOrtho Source
Decision Date1986-05-02
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOJOIN, ORTHODONTIC ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Source. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861118. 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 ORTHOJOIN, ORTHODONTIC ADHESIVE?

ORTHOJOIN, ORTHODONTIC ADHESIVE is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Ortho Source. The 510(k) number is K861118.

When did ORTHOJOIN, ORTHODONTIC ADHESIVE receive FDA 510(k) clearance?

ORTHOJOIN, ORTHODONTIC ADHESIVE received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861118.

Who is the listed applicant for ORTHOJOIN, ORTHODONTIC ADHESIVE?

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

What is the FDA product code for ORTHOJOIN, ORTHODONTIC ADHESIVE?

The FDA product code for ORTHOJOIN, ORTHODONTIC ADHESIVE is DYH.

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Other records listing Ortho Source 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.

K913853FISSURE SEALERK913854ORTHO LIGHT CUREK913519SUMO GLASS IONOMER CEMENTK884949VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINERK884575MAXIBONDK861258PERMABAND (ORTHODONTIC ADHESIVE)

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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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