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FDA 510(k)

DENTAL DAM

K-Number: K954990 · 1996-01-26

ApplicantThe Hygenic Corp.
Decision Date1996-01-26
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL DAM is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K954990. 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 DENTAL DAM?

DENTAL DAM is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is The Hygenic Corp.. The 510(k) number is K954990.

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

DENTAL DAM received FDA 510(k) clearance on 1996-01-26, under 510(k) number K954990.

Who is the listed applicant for DENTAL DAM?

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

What is the FDA product code for DENTAL DAM?

The FDA product code for DENTAL DAM is EIE.

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Other records listing The Hygenic 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.

K930764ENDO-ICE-PULP TESTER-THERMALK905418GATES GLIDDEN DRILLSK911225TRAY DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900301NOVUS BONDING AGENTK900844WEDJETS

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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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