FDA 510(k)

SURE BOND

K-Number: K993013 · 1999-11-29

Decision Date1999-11-29

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SURE BOND is the device name listed in this FDA 510(k) record. The listed applicant is Miradent Distributing Co., LLC. It received FDA 510(k) clearance on 1999-11-29 under 510(k) number K993013. 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 SURE BOND?

SURE BOND is a medical device that received FDA 510(k) clearance on 1999-11-29. The listed applicant is Miradent Distributing Co., LLC. The 510(k) number is K993013.

When did SURE BOND receive FDA 510(k) clearance?

SURE BOND received FDA 510(k) clearance on 1999-11-29, under 510(k) number K993013.

Who is the listed applicant for SURE BOND?

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

What is the FDA product code for SURE BOND?

The FDA product code for SURE BOND is KLE.

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, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.