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FDA 510(k)

OCCLUSAL HARMONY IMPRESSION TRAY

K-Number: K884316 · 1988-12-22

ApplicantAdvantage Dental Co.
Decision Date1988-12-22
Product CodeEHY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OCCLUSAL HARMONY IMPRESSION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Dental Co.. It received FDA 510(k) clearance on 1988-12-22 under 510(k) number K884316. The device is classified under product code EHY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCLUSAL HARMONY IMPRESSION TRAY?

OCCLUSAL HARMONY IMPRESSION TRAY is a medical device that received FDA 510(k) clearance on 1988-12-22. The listed applicant is Advantage Dental Co.. The 510(k) number is K884316.

When did OCCLUSAL HARMONY IMPRESSION TRAY receive FDA 510(k) clearance?

OCCLUSAL HARMONY IMPRESSION TRAY received FDA 510(k) clearance on 1988-12-22, under 510(k) number K884316.

Who is the listed applicant for OCCLUSAL HARMONY IMPRESSION TRAY?

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

What is the FDA product code for OCCLUSAL HARMONY IMPRESSION TRAY?

The FDA product code for OCCLUSAL HARMONY IMPRESSION TRAY is EHY.

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Related Devices (Code: EHY)

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.

K942668O-TRAY IMPRESSION TRAYSDentauraum, Inc.K896470EOS IMPRESSION TRAYSIvoclar North America, Inc.K863836POST TRAYMarket Masters, Inc.K850776PREFORMED DENTAL IMPRESSION TRAYSL.A.K. Ent., Inc.K842273CROWN INDEX TRAYDi-Equi Dental ProductsK842274F-G-P TRAYDi-Equi Dental Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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