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FDA 510(k)

RUBBER DAM

K-Number: K780745 · 1978-05-12

ApplicantHygienic Dental Mfg., Co., The
Decision Date1978-05-12
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RUBBER DAM is the device name listed in this FDA 510(k) record. The listed applicant is Hygienic Dental Mfg., Co., The. It received FDA 510(k) clearance on 1978-05-12 under 510(k) number K780745. 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 RUBBER DAM?

RUBBER DAM is a medical device that received FDA 510(k) clearance on 1978-05-12. The listed applicant is Hygienic Dental Mfg., Co., The. The 510(k) number is K780745.

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

RUBBER DAM received FDA 510(k) clearance on 1978-05-12, under 510(k) number K780745.

Who is the listed applicant for RUBBER DAM?

The FDA 510(k) record lists Hygienic Dental Mfg., Co., The as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBBER DAM?

The FDA product code for RUBBER DAM is EIE.

Related Clinical Trials

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.

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Other records listing Hygienic Dental Mfg., Co., The 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.

K780804HYGIENIC ANCHORINGSK780746HYGIENIC RUBBER DAM FRAMEK780744BRINKER TISSUE RETRACTORSK780743CLAMP FORCEPSK770117HYGIENIC 5 & 6 RUBBER DAM FRAME

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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