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FDA 510(k)

PREMIER TRIPLE TRAY

K-Number: K800900 · 1980-04-29

ApplicantPremier Dental Products Co.
Decision Date1980-04-29
Product CodeEHY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER TRIPLE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 1980-04-29 under 510(k) number K800900. 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 PREMIER TRIPLE TRAY?

PREMIER TRIPLE TRAY is a medical device that received FDA 510(k) clearance on 1980-04-29. The listed applicant is Premier Dental Products Co.. The 510(k) number is K800900.

When did PREMIER TRIPLE TRAY receive FDA 510(k) clearance?

PREMIER TRIPLE TRAY received FDA 510(k) clearance on 1980-04-29, under 510(k) number K800900.

Who is the listed applicant for PREMIER TRIPLE TRAY?

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

What is the FDA product code for PREMIER TRIPLE TRAY?

The FDA product code for PREMIER TRIPLE TRAY is EHY.

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Other records listing Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

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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.K884316OCCLUSAL HARMONY IMPRESSION TRAYAdvantage Dental Co.K863836POST TRAYMarket Masters, Inc.K850776PREFORMED DENTAL IMPRESSION TRAYSL.A.K. Ent., Inc.K842273CROWN INDEX TRAYDi-Equi Dental Products

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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