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)

PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST

K-Number: K850824 · 1985-04-08

ApplicantKuraray Co.
Decision Date1985-04-08
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Co.. It received FDA 510(k) clearance on 1985-04-08 under 510(k) number K850824. 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 PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST?

PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST is a medical device that received FDA 510(k) clearance on 1985-04-08. The listed applicant is Kuraray Co.. The 510(k) number is K850824.

When did PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST receive FDA 510(k) clearance?

PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST received FDA 510(k) clearance on 1985-04-08, under 510(k) number K850824.

Who is the listed applicant for PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST?

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

What is the FDA product code for PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST?

The FDA product code for PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST 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 Kuraray Co. 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.

K990040CLEARFIL SE BONDK951813CARIES DETECTORK933030PANAVIA 21K925383PHOTO CLEARFIL OPAQUERK925404CLEARFIL PORCELAIN BOND ACTIVATORK912707CLEARFIL LINER BOND SYSTEM

View all 25 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.

↑