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FDA 510(k)

KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10

K-Number: K112758 · 2012-02-23

ApplicantKat Implants, LLC
Decision Date2012-02-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 is the device name listed in this FDA 510(k) record. The listed applicant is Kat Implants, LLC. It received FDA 510(k) clearance on 2012-02-23 under 510(k) number K112758. 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 KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10?

KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 is a medical device that received FDA 510(k) clearance on 2012-02-23. The listed applicant is Kat Implants, LLC. The 510(k) number is K112758.

When did KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 receive FDA 510(k) clearance?

KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 received FDA 510(k) clearance on 2012-02-23, under 510(k) number K112758.

Who is the listed applicant for KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10?

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

What is the FDA product code for KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10?

The FDA product code for KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 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 Kat Implants, LLC 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.

K101201STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,K083544KAT IMPLANT 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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