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)

SR PHONARES II

K-Number: K120736 · 2012-05-14

ApplicantIvoclar Vivadent, AG
Decision Date2012-05-14
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SR PHONARES II is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2012-05-14 under 510(k) number K120736. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR PHONARES II?

SR PHONARES II is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K120736.

When did SR PHONARES II receive FDA 510(k) clearance?

SR PHONARES II received FDA 510(k) clearance on 2012-05-14, under 510(k) number K120736.

Who is the listed applicant for SR PHONARES II?

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

What is the FDA product code for SR PHONARES II?

The FDA product code for SR PHONARES II is ELM.

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 Ivoclar Vivadent, AG 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.

K210804Adhese Universal DC, Cention PrimerK211916IPS e.max OneK193193Telio CAD Abutment Solutions- extra systemsK191453Cervitec FK191448Barrier SleevesK191382IPS e.max CAD Abutment Solutions- extra systems

View all 24 devices →

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK113426VERACIA SAShofu Dental Corporation

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.

↑