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FDA 510(k)

3I LOCATER ABUTMENT SYSTEM

K-Number: K012911 · 2001-09-28

ApplicantImplant Innovations, Inc.
Decision Date2001-09-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I LOCATER ABUTMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012911. 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 3I LOCATER ABUTMENT SYSTEM?

3I LOCATER ABUTMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K012911.

When did 3I LOCATER ABUTMENT SYSTEM receive FDA 510(k) clearance?

3I LOCATER ABUTMENT SYSTEM received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012911.

Who is the listed applicant for 3I LOCATER ABUTMENT SYSTEM?

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

What is the FDA product code for 3I LOCATER ABUTMENT SYSTEM?

The FDA product code for 3I LOCATER ABUTMENT SYSTEM is DZE.

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Other records listing Implant Innovations, Inc. as applicant

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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

View on FDA Database →

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

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