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FDA 510(k)

GINGITRACT

K-Number: K771973 · 1977-11-07

ApplicantDen-Mat Corp.
Decision Date1977-11-07
Product CodeEIG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GINGITRACT is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Corp.. It received FDA 510(k) clearance on 1977-11-07 under 510(k) number K771973. The device is classified under product code EIG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GINGITRACT?

GINGITRACT is a medical device that received FDA 510(k) clearance on 1977-11-07. The listed applicant is Den-Mat Corp.. The 510(k) number is K771973.

When did GINGITRACT receive FDA 510(k) clearance?

GINGITRACT received FDA 510(k) clearance on 1977-11-07, under 510(k) number K771973.

Who is the listed applicant for GINGITRACT?

The FDA 510(k) record lists Den-Mat Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GINGITRACT?

The FDA product code for GINGITRACT is EIG.

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Other records listing Den-Mat Corp. 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.

K9831061ST IMPRESSIONK895731DEN-MAT CERINATE PORCELAINK895269DEN-MAT LAMI-QUICKK881918LIGHT-CURED ZIONOMER CEMENTK875351DEN-MAT PORETCH (PORCELAIN ETCHANT)K872510DEN-MAT TENURE

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Related Devices (Code: EIG)

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.

K971284OPALDAMUltradent Products, Inc.K854711FIBRELIGHT ILLUMINATING ORAL RETRACTORSDowns Surgical , Ltd.K832366ZOLLER BURNED LIP CONFORMERUniversal Prosthetics, Inc.K821784BEACH GINGIVAL RETRACTION INSTR. TYPE BPacific Dental Corp.K771399LIP & CHEEK RETRACTORL.D. Caulk Co.K761024RACESTYPTINE RINGSSeptodont, 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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