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FDA 510(k)

AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR

K-Number: K821895 · 1982-07-16

ApplicantAmerican Midwest
Decision Date1982-07-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR is the device name listed in this FDA 510(k) record. The listed applicant is American Midwest. It received FDA 510(k) clearance on 1982-07-16 under 510(k) number K821895. 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 AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR?

AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR is a medical device that received FDA 510(k) clearance on 1982-07-16. The listed applicant is American Midwest. The 510(k) number is K821895.

When did AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR receive FDA 510(k) clearance?

AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR received FDA 510(k) clearance on 1982-07-16, under 510(k) number K821895.

Who is the listed applicant for AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR?

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

What is the FDA product code for AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR?

The FDA product code for AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR 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 American Midwest 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.

K821715AM-40 SYSTEMK820693MIDWEST LIGHT WANDK811979ATT-1 DENTAL COMPOSITE RESTORATIVE SYSK800735U-STYLE ADAPTER

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.

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