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FDA 510(k)

AMERICAN DENTAL PRODUCTS SE BONDEASY

K-Number: K093014 · 2010-04-16

ApplicantAmerican Dental Products, Inc.
Decision Date2010-04-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMERICAN DENTAL PRODUCTS SE BONDEASY is the device name listed in this FDA 510(k) record. The listed applicant is American Dental Products, Inc.. It received FDA 510(k) clearance on 2010-04-16 under 510(k) number K093014. 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 AMERICAN DENTAL PRODUCTS SE BONDEASY?

AMERICAN DENTAL PRODUCTS SE BONDEASY is a medical device that received FDA 510(k) clearance on 2010-04-16. The listed applicant is American Dental Products, Inc.. The 510(k) number is K093014.

When did AMERICAN DENTAL PRODUCTS SE BONDEASY receive FDA 510(k) clearance?

AMERICAN DENTAL PRODUCTS SE BONDEASY received FDA 510(k) clearance on 2010-04-16, under 510(k) number K093014.

Who is the listed applicant for AMERICAN DENTAL PRODUCTS SE BONDEASY?

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

What is the FDA product code for AMERICAN DENTAL PRODUCTS SE BONDEASY?

The FDA product code for AMERICAN DENTAL PRODUCTS SE BONDEASY is KLE.

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Other records listing American Dental Products, Inc. as applicant

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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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