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FDA 510(k)

DREAM DAM

K-Number: K875255 · 1988-03-18

ApplicantDental Dam, Inc.
Decision Date1988-03-18
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DREAM DAM is the device name listed in this FDA 510(k) record. The listed applicant is Dental Dam, Inc.. It received FDA 510(k) clearance on 1988-03-18 under 510(k) number K875255. 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 DREAM DAM?

DREAM DAM is a medical device that received FDA 510(k) clearance on 1988-03-18. The listed applicant is Dental Dam, Inc.. The 510(k) number is K875255.

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

DREAM DAM received FDA 510(k) clearance on 1988-03-18, under 510(k) number K875255.

Who is the listed applicant for DREAM DAM?

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

What is the FDA product code for DREAM DAM?

The FDA product code for DREAM 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 Dental Dam, Inc. 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.

K864096DREAM DAM

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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