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FDA 510(k)

KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM

K-Number: K955048 · 1996-01-11

ApplicantThe Implant Center of the Palm Beaches
Decision Date1996-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Implant Center of the Palm Beaches. It received FDA 510(k) clearance on 1996-01-11 under 510(k) number K955048. 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 KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM?

KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is The Implant Center of the Palm Beaches. The 510(k) number is K955048.

When did KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM receive FDA 510(k) clearance?

KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM received FDA 510(k) clearance on 1996-01-11, under 510(k) number K955048.

Who is the listed applicant for KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM?

The FDA 510(k) record lists The Implant Center of the Palm Beaches as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM?

The FDA product code for KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM is DZE.

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Other records listing The Implant Center of the Palm Beaches 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.

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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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