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FDA 510(k)

BOSWORTH DENTIN RESIN

K-Number: K061611 · 2006-09-11

ApplicantHarry J. Bosworth Co.
Decision Date2006-09-11
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOSWORTH DENTIN RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 2006-09-11 under 510(k) number K061611. 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 BOSWORTH DENTIN RESIN?

BOSWORTH DENTIN RESIN is a medical device that received FDA 510(k) clearance on 2006-09-11. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K061611.

When did BOSWORTH DENTIN RESIN receive FDA 510(k) clearance?

BOSWORTH DENTIN RESIN received FDA 510(k) clearance on 2006-09-11, under 510(k) number K061611.

Who is the listed applicant for BOSWORTH DENTIN RESIN?

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

What is the FDA product code for BOSWORTH DENTIN RESIN?

The FDA product code for BOSWORTH DENTIN RESIN is KLE.

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Other records listing Harry J. Bosworth 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.

K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPK100731BOSWORTH AIR POLISHERK051224BOSWORTH SEALK043170BOSWORTH BONDK040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVEK040547AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

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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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