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FDA 510(k)

TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

K-Number: K003818 · 2001-07-05

ApplicantTitan Implants
Decision Date2001-07-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Titan Implants. It received FDA 510(k) clearance on 2001-07-05 under 510(k) number K003818. 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 TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS?

TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS is a medical device that received FDA 510(k) clearance on 2001-07-05. The listed applicant is Titan Implants. The 510(k) number is K003818.

When did TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS receive FDA 510(k) clearance?

TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS received FDA 510(k) clearance on 2001-07-05, under 510(k) number K003818.

Who is the listed applicant for TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS?

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 TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS?

The FDA product code for TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS 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.

K001638O-RING PROSTHETIC ATTACHMENT

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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