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)

IMPLANT CENTER 2

K-Number: K091252 · 2009-07-22

ApplicantSatelec
Decision Date2009-07-22
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANT CENTER 2 is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2009-07-22 under 510(k) number K091252. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT CENTER 2?

IMPLANT CENTER 2 is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is Satelec. The 510(k) number is K091252.

When did IMPLANT CENTER 2 receive FDA 510(k) clearance?

IMPLANT CENTER 2 received FDA 510(k) clearance on 2009-07-22, under 510(k) number K091252.

Who is the listed applicant for IMPLANT CENTER 2?

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

What is the FDA product code for IMPLANT CENTER 2?

The FDA product code for IMPLANT CENTER 2 is DZI.

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 Satelec 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.

K110379AIR-N-GOK100410PIEZOELECTRIC SYSTEMK091331PIEZOTOME 2K082116HEMOSTASYL PASTEK072181MINI LED AUTOFOCUSK071965I-SURGE

View all 24 devices →

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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.

↑