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FDA 510(k)

HYDROXI-FLEX IMPLANT

K-Number: K812321 · 1981-10-29

ApplicantImpladent
Decision Date1981-10-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROXI-FLEX IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Impladent. It received FDA 510(k) clearance on 1981-10-29 under 510(k) number K812321. 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 HYDROXI-FLEX IMPLANT?

HYDROXI-FLEX IMPLANT is a medical device that received FDA 510(k) clearance on 1981-10-29. The listed applicant is Impladent. The 510(k) number is K812321.

When did HYDROXI-FLEX IMPLANT receive FDA 510(k) clearance?

HYDROXI-FLEX IMPLANT received FDA 510(k) clearance on 1981-10-29, under 510(k) number K812321.

Who is the listed applicant for HYDROXI-FLEX IMPLANT?

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

What is the FDA product code for HYDROXI-FLEX IMPLANT?

The FDA product code for HYDROXI-FLEX IMPLANT is DZE.

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 Impladent 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.

K923310OSTEOGEN (HA RESORB)K881662EXPANDED CLAIMES TO OSTEOGEN(R)K843398OSTEOGENK792663FLEXI-CUP IMPLANT

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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