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FDA 510(k)

ODONT HEX SYSTEM

K-Number: K961631 · 1997-05-12

ApplicantOdontit S.A.
Decision Date1997-05-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODONT HEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Odontit S.A.. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K961631. 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 ODONT HEX SYSTEM?

ODONT HEX SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Odontit S.A.. The 510(k) number is K961631.

When did ODONT HEX SYSTEM receive FDA 510(k) clearance?

ODONT HEX SYSTEM received FDA 510(k) clearance on 1997-05-12, under 510(k) number K961631.

Who is the listed applicant for ODONT HEX SYSTEM?

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

What is the FDA product code for ODONT HEX SYSTEM?

The FDA product code for ODONT HEX SYSTEM 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 Odontit S.A. 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.

K072917JJG EVOLUTION ORTHODONTIC 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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