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FDA 510(k)

ETEX DENTAL IMPLANT SYSTEM

K-Number: K913417 · 1992-02-19

ApplicantEtex Co.
Decision Date1992-02-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETEX DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etex Co.. It received FDA 510(k) clearance on 1992-02-19 under 510(k) number K913417. 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 ETEX DENTAL IMPLANT SYSTEM?

ETEX DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-02-19. The listed applicant is Etex Co.. The 510(k) number is K913417.

When did ETEX DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

ETEX DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1992-02-19, under 510(k) number K913417.

Who is the listed applicant for ETEX DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for ETEX DENTAL IMPLANT SYSTEM?

The FDA product code for ETEX DENTAL IMPLANT 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 Etex Co. 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.

K925895ETEX HIP REPLACEMENT 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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