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FDA 510(k)

PHASE II ORTHODONTIC ADHESIVE

K-Number: K895523 · 1989-12-08

ApplicantReliance Orthodontic Products, Inc.
Decision Date1989-12-08
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHASE II ORTHODONTIC ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 1989-12-08 under 510(k) number K895523. 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 PHASE II ORTHODONTIC ADHESIVE?

PHASE II ORTHODONTIC ADHESIVE is a medical device that received FDA 510(k) clearance on 1989-12-08. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K895523.

When did PHASE II ORTHODONTIC ADHESIVE receive FDA 510(k) clearance?

PHASE II ORTHODONTIC ADHESIVE received FDA 510(k) clearance on 1989-12-08, under 510(k) number K895523.

Who is the listed applicant for PHASE II ORTHODONTIC ADHESIVE?

The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASE II ORTHODONTIC ADHESIVE?

The FDA product code for PHASE II ORTHODONTIC ADHESIVE is DYH.

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Other records listing Reliance Orthodontic Products, Inc. as applicant

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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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