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)

3.25MM SPLINE TWIST IMPLANT

K-Number: K012055 · 2001-09-06

ApplicantSulzer Dental, Inc.
Decision Date2001-09-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3.25MM SPLINE TWIST IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Dental, Inc.. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K012055. 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 3.25MM SPLINE TWIST IMPLANT?

3.25MM SPLINE TWIST IMPLANT is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Sulzer Dental, Inc.. The 510(k) number is K012055.

When did 3.25MM SPLINE TWIST IMPLANT receive FDA 510(k) clearance?

3.25MM SPLINE TWIST IMPLANT received FDA 510(k) clearance on 2001-09-06, under 510(k) number K012055.

Who is the listed applicant for 3.25MM SPLINE TWIST IMPLANT?

The FDA 510(k) record lists Sulzer Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3.25MM SPLINE TWIST IMPLANT?

The FDA product code for 3.25MM SPLINE TWIST IMPLANT 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 Sulzer Dental, Inc. 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.

K014050HEX-LOCK TEMPORARY ABUTMENTK014175SULZER DENTAL CERAMIC SYSTEM-HEXLOCKK014214SULZER DENTAL CERAMIC SYSTEM-SPLINEK0134943.75MM AND 5.0MM SPLINE TWIST IMPLANTK013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTK011245ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM

View all 9 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.

↑