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FDA 510(k)

DEN-MAT PAINT-ON RUBBER DAM

K-Number: K852630 · 1985-12-18

ApplicantDen-Mat Corp.
Decision Date1985-12-18
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEN-MAT PAINT-ON RUBBER DAM 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 1985-12-18 under 510(k) number K852630. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEN-MAT PAINT-ON RUBBER DAM?

DEN-MAT PAINT-ON RUBBER DAM is a medical device that received FDA 510(k) clearance on 1985-12-18. The listed applicant is Den-Mat Corp.. The 510(k) number is K852630.

When did DEN-MAT PAINT-ON RUBBER DAM receive FDA 510(k) clearance?

DEN-MAT PAINT-ON RUBBER DAM received FDA 510(k) clearance on 1985-12-18, under 510(k) number K852630.

Who is the listed applicant for DEN-MAT PAINT-ON RUBBER DAM?

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 DEN-MAT PAINT-ON RUBBER DAM?

The FDA product code for DEN-MAT PAINT-ON RUBBER DAM is EIE.

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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: EIE)

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.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

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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