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)

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

K-Number: K052097 · 2005-08-12

ApplicantDentsply International
Decision Date2005-08-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2005-08-12 under 510(k) number K052097. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE?

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE is a medical device that received FDA 510(k) clearance on 2005-08-12. The listed applicant is Dentsply International. The 510(k) number is K052097.

When did CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE receive FDA 510(k) clearance?

CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE received FDA 510(k) clearance on 2005-08-12, under 510(k) number K052097.

Who is the listed applicant for CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE?

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

What is the FDA product code for CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE?

The FDA product code for CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE is EBF.

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 Dentsply International 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.

K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSK061580ECLIPSE WAX REMOVERK060837IN-OVATION CK053368INTERPROXIMAL REDUCTION SYSTEMK052370CP BRACKET SYSTEMK050208FRIADENT ESTHETICAP

View all 23 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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.

↑