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FDA 510(k)

DENT-DR. VACU-FRAME

K-Number: K851045 · 1985-04-22

ApplicantDent-Dr.
Decision Date1985-04-22
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENT-DR. VACU-FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Dent-Dr.. It received FDA 510(k) clearance on 1985-04-22 under 510(k) number K851045. 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 DENT-DR. VACU-FRAME?

DENT-DR. VACU-FRAME is a medical device that received FDA 510(k) clearance on 1985-04-22. The listed applicant is Dent-Dr.. The 510(k) number is K851045.

When did DENT-DR. VACU-FRAME receive FDA 510(k) clearance?

DENT-DR. VACU-FRAME received FDA 510(k) clearance on 1985-04-22, under 510(k) number K851045.

Who is the listed applicant for DENT-DR. VACU-FRAME?

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

What is the FDA product code for DENT-DR. VACU-FRAME?

The FDA product code for DENT-DR. VACU-FRAME is EIE.

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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

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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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