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FDA 510(k)

IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER

K-Number: K905039 · 1991-04-29

ApplicantMinimatic Implant Technology
Decision Date1991-04-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER is the device name listed in this FDA 510(k) record. The listed applicant is Minimatic Implant Technology. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K905039. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER?

IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Minimatic Implant Technology. The 510(k) number is K905039.

When did IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER receive FDA 510(k) clearance?

IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER received FDA 510(k) clearance on 1991-04-29, under 510(k) number K905039.

Who is the listed applicant for IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER?

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

What is the FDA product code for IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER?

The FDA product code for IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER is DZE.

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Other records listing Minimatic Implant Technology 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.

K911776DPI-1106 IMPLANT, MODIFICATIONK903515HH-1119 HEALING HEADK911112DEVICE PART NUMBERS: - 1400 SERIESK904707BC 1208 IMPLANT, THREADED EXTERNAL HEXK903043ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT)K903046IDT-1104 IMPLANT (SCREW-IN-THREADED)

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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