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FDA 510(k)

KIS-II IMPLANT SYSTEM/DRILLS

K-Number: K944356 · 1994-12-05

ApplicantImplant Center of the Palm Beaches
Decision Date1994-12-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KIS-II IMPLANT SYSTEM/DRILLS is the device name listed in this FDA 510(k) record. The listed applicant is Implant Center of the Palm Beaches. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K944356. 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-II IMPLANT SYSTEM/DRILLS?

KIS-II IMPLANT SYSTEM/DRILLS is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Implant Center of the Palm Beaches. The 510(k) number is K944356.

When did KIS-II IMPLANT SYSTEM/DRILLS receive FDA 510(k) clearance?

KIS-II IMPLANT SYSTEM/DRILLS received FDA 510(k) clearance on 1994-12-05, under 510(k) number K944356.

Who is the listed applicant for KIS-II IMPLANT SYSTEM/DRILLS?

The FDA 510(k) record lists 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-II IMPLANT SYSTEM/DRILLS?

The FDA product code for KIS-II IMPLANT SYSTEM/DRILLS is DZE.

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Other records listing 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.

K953001TP-4K SCREW IMPLANT 3.3, 3.75, 4.0K952997PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLEDK952992PROSTHETICS 4MMK952994TP-4 WIDE CYLINDER IMPLANTSK953000WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MMK952985WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS

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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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