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FDA 510(k)

HYGIENIC 5 & 6 RUBBER DAM FRAME

K-Number: K770117 · 1977-01-28

ApplicantHygienic Dental Mfg., Co., The
Decision Date1977-01-28
Product CodeEJE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYGIENIC 5 & 6 RUBBER DAM FRAME 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 1977-01-28 under 510(k) number K770117. The device is classified under product code EJE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYGIENIC 5 & 6 RUBBER DAM FRAME?

HYGIENIC 5 & 6 RUBBER DAM FRAME is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is Hygienic Dental Mfg., Co., The. The 510(k) number is K770117.

When did HYGIENIC 5 & 6 RUBBER DAM FRAME receive FDA 510(k) clearance?

HYGIENIC 5 & 6 RUBBER DAM FRAME received FDA 510(k) clearance on 1977-01-28, under 510(k) number K770117.

Who is the listed applicant for HYGIENIC 5 & 6 RUBBER DAM FRAME?

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 HYGIENIC 5 & 6 RUBBER DAM FRAME?

The FDA product code for HYGIENIC 5 & 6 RUBBER DAM FRAME is EJE.

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 FORCEPSK780745RUBBER DAM

Related Devices (Code: EJE)

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.

K781520RUBBER DAM HOLDERYoung Dental Manufacturing Co. 1, LLCK780746HYGIENIC RUBBER DAM FRAMEHygienic Dental Mfg., Co., The

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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