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FDA 510(k)

3I ASYST ABUTMENT PACKAGE SYSTEM

K-Number: K951553 · 1995-06-30

ApplicantImplant Innovations, Inc.
Decision Date1995-06-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I ASYST ABUTMENT PACKAGE 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 1995-06-30 under 510(k) number K951553. 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 ASYST ABUTMENT PACKAGE SYSTEM?

3I ASYST ABUTMENT PACKAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-30. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K951553.

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

3I ASYST ABUTMENT PACKAGE SYSTEM received FDA 510(k) clearance on 1995-06-30, under 510(k) number K951553.

Who is the listed applicant for 3I ASYST ABUTMENT PACKAGE 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 ASYST ABUTMENT PACKAGE SYSTEM?

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

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Other records listing Implant Innovations, Inc. 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.

K062636OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTSK0633413I OSSEOTITE CERTAIN DENTAL IMPLANTSK063286OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITEK063403CONICAL ANGLED ABUTMENTK061629CERTAIN PREVAIL DENTAL IMPLANTK062432NANOTITE DENTAL IMPLANTS

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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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