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FDA 510(k)

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS

K-Number: K970992 · 1997-06-17

ApplicantPremier Dental Products Co.
Decision Date1997-06-17
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS 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 1997-06-17 under 510(k) number K970992. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS?

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS is a medical device that received FDA 510(k) clearance on 1997-06-17. The listed applicant is Premier Dental Products Co.. The 510(k) number is K970992.

When did PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS receive FDA 510(k) clearance?

PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS received FDA 510(k) clearance on 1997-06-17, under 510(k) number K970992.

Who is the listed applicant for PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS?

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 NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS?

The FDA product code for PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS is GEH.

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Other records listing Premier Dental Products Co. as applicant

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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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