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FDA 510(k)

O-RING PROSTHETIC ATTACHMENT

K-Number: K001638 · 2002-03-04

ApplicantTitan Implants
Decision Date2002-03-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O-RING PROSTHETIC ATTACHMENT is the device name listed in this FDA 510(k) record. The listed applicant is Titan Implants. It received FDA 510(k) clearance on 2002-03-04 under 510(k) number K001638. 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 O-RING PROSTHETIC ATTACHMENT?

O-RING PROSTHETIC ATTACHMENT is a medical device that received FDA 510(k) clearance on 2002-03-04. The listed applicant is Titan Implants. The 510(k) number is K001638.

When did O-RING PROSTHETIC ATTACHMENT receive FDA 510(k) clearance?

O-RING PROSTHETIC ATTACHMENT received FDA 510(k) clearance on 2002-03-04, under 510(k) number K001638.

Who is the listed applicant for O-RING PROSTHETIC ATTACHMENT?

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

What is the FDA product code for O-RING PROSTHETIC ATTACHMENT?

The FDA product code for O-RING PROSTHETIC ATTACHMENT 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 Titan Implants 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.

K003818TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

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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