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FDA 510(k)

PREFORMED TEMPLATE FOR TOOTH POSITIONER

K-Number: K891328 · 1989-03-31

ApplicantAmerican Orthodontics
Decision Date1989-03-31
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREFORMED TEMPLATE FOR TOOTH POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K891328. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFORMED TEMPLATE FOR TOOTH POSITIONER?

PREFORMED TEMPLATE FOR TOOTH POSITIONER is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is American Orthodontics. The 510(k) number is K891328.

When did PREFORMED TEMPLATE FOR TOOTH POSITIONER receive FDA 510(k) clearance?

PREFORMED TEMPLATE FOR TOOTH POSITIONER received FDA 510(k) clearance on 1989-03-31, under 510(k) number K891328.

Who is the listed applicant for PREFORMED TEMPLATE FOR TOOTH POSITIONER?

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

What is the FDA product code for PREFORMED TEMPLATE FOR TOOTH POSITIONER?

The FDA product code for PREFORMED TEMPLATE FOR TOOTH POSITIONER is KMY.

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Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.

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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