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FDA 510(k)

PY-RITE

K-Number: K853758 · 1985-12-03

ApplicantGolden Dental Products, Inc.
Decision Date1985-12-03
Product CodeNJH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PY-RITE is the device name listed in this FDA 510(k) record. The listed applicant is Golden Dental Products, Inc.. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K853758. The device is classified under product code NJH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PY-RITE?

PY-RITE is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Golden Dental Products, Inc.. The 510(k) number is K853758.

When did PY-RITE receive FDA 510(k) clearance?

PY-RITE received FDA 510(k) clearance on 1985-12-03, under 510(k) number K853758.

Who is the listed applicant for PY-RITE?

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

What is the FDA product code for PY-RITE?

The FDA product code for PY-RITE is NJH.

Related Devices (Code: NJH)

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.

K022373CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENSCantor & Nissel , Ltd.

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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