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FDA 510(k)

MADEGOM LTDA. DENTAL DAM

K-Number: K894120 · 1989-08-21

ApplicantMadegom
Decision Date1989-08-21
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MADEGOM LTDA. DENTAL DAM is the device name listed in this FDA 510(k) record. The listed applicant is Madegom. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K894120. 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 MADEGOM LTDA. DENTAL DAM?

MADEGOM LTDA. DENTAL DAM is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Madegom. The 510(k) number is K894120.

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

MADEGOM LTDA. DENTAL DAM received FDA 510(k) clearance on 1989-08-21, under 510(k) number K894120.

Who is the listed applicant for MADEGOM LTDA. DENTAL DAM?

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

What is the FDA product code for MADEGOM LTDA. DENTAL DAM?

The FDA product code for MADEGOM LTDA. DENTAL 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 Madegom 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.

K894119MADEGOM LTDA. PENROSE DRAIN TUBING

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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