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FDA 510(k)

PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX

K-Number: K781035 · 1978-06-30

ApplicantPremier Dental Products Co.
Decision Date1978-06-30
Product CodeEMN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX 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 1978-06-30 under 510(k) number K781035. The device is classified under product code EMN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX?

PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX is a medical device that received FDA 510(k) clearance on 1978-06-30. The listed applicant is Premier Dental Products Co.. The 510(k) number is K781035.

When did PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX receive FDA 510(k) clearance?

PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX received FDA 510(k) clearance on 1978-06-30, under 510(k) number K781035.

Who is the listed applicant for PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX?

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 PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX?

The FDA product code for PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX is EMN.

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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 PROK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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Related Devices (Code: EMN)

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.

K070127PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02Kevin Vu, DdsK931330DENTAL INSTRUMENTS SCALERMinnesota Prophy Power, Inc.K8517211200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERSArtiberiaK821786BEACH SCALERSPacific Dental Corp.

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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