Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED

K-Number: K952997 · 1995-10-31

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

Device Summary

PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED 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 K952997. 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 PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED?

PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED 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 K952997.

When did PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED receive FDA 510(k) clearance?

PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED received FDA 510(k) clearance on 1995-10-31, under 510(k) number K952997.

Who is the listed applicant for PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED?

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 PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED?

The FDA product code for PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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, 4.0K952992PROSTHETICS 4MMK952994TP-4 WIDE CYLINDER IMPLANTSK953000WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MMK952998TP SCREW IMPLANT 3.75, 4.0-B5

View all 20 devices →

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.

↑