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FDA 510(k)

HA/TP COATED CYLINDER IMPLANT 3.3,4.0

K-Number: K952996 · 1995-10-31

ApplicantImplant Center of the Palm Beaches
Decision Date1995-10-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HA/TP COATED CYLINDER IMPLANT 3.3,4.0 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 1995-10-31 under 510(k) number K952996. 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 HA/TP COATED CYLINDER IMPLANT 3.3,4.0?

HA/TP COATED CYLINDER IMPLANT 3.3,4.0 is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Implant Center of the Palm Beaches. The 510(k) number is K952996.

When did HA/TP COATED CYLINDER IMPLANT 3.3,4.0 receive FDA 510(k) clearance?

HA/TP COATED CYLINDER IMPLANT 3.3,4.0 received FDA 510(k) clearance on 1995-10-31, under 510(k) number K952996.

Who is the listed applicant for HA/TP COATED CYLINDER IMPLANT 3.3,4.0?

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 HA/TP COATED CYLINDER IMPLANT 3.3,4.0?

The FDA product code for HA/TP COATED CYLINDER IMPLANT 3.3,4.0 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.

K952985WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SSK953001TP-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, 6MM

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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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