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FDA 510(k)

CLEARFIL NEW BOND

K-Number: K943167 · 1994-08-10

ApplicantKuraray Company, Ltd.
Decision Date1994-08-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLEARFIL NEW BOND is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Company, Ltd.. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K943167. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIL NEW BOND?

CLEARFIL NEW BOND is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is Kuraray Company, Ltd.. The 510(k) number is K943167.

When did CLEARFIL NEW BOND receive FDA 510(k) clearance?

CLEARFIL NEW BOND received FDA 510(k) clearance on 1994-08-10, under 510(k) number K943167.

Who is the listed applicant for CLEARFIL NEW BOND?

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

What is the FDA product code for CLEARFIL NEW BOND?

The FDA product code for CLEARFIL NEW BOND is KLE.

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 Company, Ltd. 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.

K001914CLEARFIL REPAIRK001913CLEARFIL ST OPAQUERK980232CLEARFIL DC CEMENTK965091TEETHMATE F-1K943168CLEARFIL AP-XK943165CLEARFIL PHOTO BOND

View all 10 devices →

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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