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FDA 510(k)

PREMIER PROMAX BITE GUARD

K-Number: K941856 · 1995-04-05

ApplicantPremier Dental Products Co.
Decision Date1995-04-05
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PREMIER PROMAX BITE GUARD 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 1995-04-05 under 510(k) number K941856. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER PROMAX BITE GUARD?

PREMIER PROMAX BITE GUARD is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Premier Dental Products Co.. The 510(k) number is K941856.

When did PREMIER PROMAX BITE GUARD receive FDA 510(k) clearance?

PREMIER PROMAX BITE GUARD received FDA 510(k) clearance on 1995-04-05, under 510(k) number K941856.

Who is the listed applicant for PREMIER PROMAX BITE GUARD?

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 PROMAX BITE GUARD?

The FDA product code for PREMIER PROMAX BITE GUARD is JXL.

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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 PRIMERK083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061998PREMIER SELF-ETCHING BOND ENHANCER

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Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.

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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