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FDA 510(k)

ALL-BOUND 3

K-Number: K102844 · 2010-10-29

ApplicantBisco, Inc.
Decision Date2010-10-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALL-BOUND 3 is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K102844. 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 ALL-BOUND 3?

ALL-BOUND 3 is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Bisco, Inc.. The 510(k) number is K102844.

When did ALL-BOUND 3 receive FDA 510(k) clearance?

ALL-BOUND 3 received FDA 510(k) clearance on 2010-10-29, under 510(k) number K102844.

Who is the listed applicant for ALL-BOUND 3?

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

What is the FDA product code for ALL-BOUND 3?

The FDA product code for ALL-BOUND 3 is KLE.

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Other records listing Bisco, 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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