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)

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

K-Number: K002469 · 2001-02-07

ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2001-02-07
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2001-02-07 under 510(k) number K002469. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)?

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) is a medical device that received FDA 510(k) clearance on 2001-02-07. The listed applicant is W&H Dentalwerk Buermoos GmbH. The 510(k) number is K002469.

When did IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) receive FDA 510(k) clearance?

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) received FDA 510(k) clearance on 2001-02-07, under 510(k) number K002469.

Who is the listed applicant for IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)?

The FDA 510(k) record lists W&H Dentalwerk Buermoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)?

The FDA product code for IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) is EBW.

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 W&H Dentalwerk Buermoos GmbH 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.

K253776Implantmed Plus II & Piezomed Plus II ModuleK243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)K201703PROXEO Twist Cordless Polishing System PL-40 HK181858Electric Handpiece MotorK171553W&H Assistina TwinK100600PROSTHODONTIC SCREWDRIVER , MODEL IA-400

View all 16 devices →

Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, 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.

↑