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)

SOLOCEM

K-Number: K121621 · 2013-01-08

ApplicantColtene/Whaledent AG
Decision Date2013-01-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLOCEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2013-01-08 under 510(k) number K121621. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOCEM?

SOLOCEM is a medical device that received FDA 510(k) clearance on 2013-01-08. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K121621.

When did SOLOCEM receive FDA 510(k) clearance?

SOLOCEM received FDA 510(k) clearance on 2013-01-08, under 510(k) number K121621.

Who is the listed applicant for SOLOCEM?

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

What is the FDA product code for SOLOCEM?

The FDA product code for SOLOCEM is EMA.

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 Coltene/Whaledent 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.

K191385BRILLIANT COMPONEERK190597BRILLIANT EverGlow FlowK181500BRILLIANT CriosK160800DuoCemK152927BRILLIANT EVERGLOWK112168COMPONEER

View all 14 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, 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.

↑