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FDA 510(k)

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER

K-Number: K904128 · 1990-11-09

ApplicantAmerican Orthodontics
Decision Date1990-11-09
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1990-11-09 under 510(k) number K904128. 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 PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER?

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER is a medical device that received FDA 510(k) clearance on 1990-11-09. The listed applicant is American Orthodontics. The 510(k) number is K904128.

When did PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER receive FDA 510(k) clearance?

PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER received FDA 510(k) clearance on 1990-11-09, under 510(k) number K904128.

Who is the listed applicant for PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER?

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 PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER?

The FDA product code for PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER 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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