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FDA 510(k)

VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.

K-Number: K904813 · 1991-05-31

ApplicantAlpha-Dent
Decision Date1991-05-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Dent. It received FDA 510(k) clearance on 1991-05-31 under 510(k) number K904813. 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 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.?

VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. is a medical device that received FDA 510(k) clearance on 1991-05-31. The listed applicant is Alpha-Dent. The 510(k) number is K904813.

When did VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. receive FDA 510(k) clearance?

VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. received FDA 510(k) clearance on 1991-05-31, under 510(k) number K904813.

Who is the listed applicant for VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.?

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 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.?

The FDA product code for VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. 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.

K932828CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN COREK932829CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PASTK932826CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUOK932827ALPHA-DENT CORE BUILDUP PASTEK904812COMPOSITE 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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