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FDA 510(k)

DENTI-D RUBBER DAM

K-Number: K842844 · 1984-08-17

ApplicantFema Corp.
Decision Date1984-08-17
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTI-D RUBBER DAM is the device name listed in this FDA 510(k) record. The listed applicant is Fema Corp.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842844. 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 DENTI-D RUBBER DAM?

DENTI-D RUBBER DAM is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Fema Corp.. The 510(k) number is K842844.

When did DENTI-D RUBBER DAM receive FDA 510(k) clearance?

DENTI-D RUBBER DAM received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842844.

Who is the listed applicant for DENTI-D RUBBER DAM?

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

What is the FDA product code for DENTI-D RUBBER DAM?

The FDA product code for DENTI-D RUBBER DAM is EIE.

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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

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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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