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FDA 510(k)

CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE

K-Number: K932828 · 1994-02-03

ApplicantAlpha-Dent
Decision Date1994-02-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Dent. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K932828. 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 CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE?

CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Alpha-Dent. The 510(k) number is K932828.

When did CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE receive FDA 510(k) clearance?

CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE received FDA 510(k) clearance on 1994-02-03, under 510(k) number K932828.

Who is the listed applicant for CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE?

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

What is the FDA product code for CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE?

The FDA product code for CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE 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 Alpha-Dent 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.

K932829CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PASTK932826CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUOK932827ALPHA-DENT CORE BUILDUP PASTEK904813VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.K904812COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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