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FDA 510(k)

IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM

K-Number: K921854 · 1992-10-27

ApplicantImpla-Med
Decision Date1992-10-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM is the device name listed in this FDA 510(k) record. The listed applicant is Impla-Med. It received FDA 510(k) clearance on 1992-10-27 under 510(k) number K921854. 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 IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM?

IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM is a medical device that received FDA 510(k) clearance on 1992-10-27. The listed applicant is Impla-Med. The 510(k) number is K921854.

When did IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM receive FDA 510(k) clearance?

IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM received FDA 510(k) clearance on 1992-10-27, under 510(k) number K921854.

Who is the listed applicant for IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM?

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

What is the FDA product code for IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM?

The FDA product code for IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM is DZE.

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Other records listing Impla-Med 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.

K902911TITANIUM/STAINLESS STEEL INSTRUMENTSK902158TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMPK900061IMPLA-MED TITANIUM, IMPLANT DEVICESK892124IMPLA-MED IMPLANT SYSTEM

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

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