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FDA 510(k)

OPTIBOND SOLO PLUS 3

K-Number: K011908 · 2001-09-06

ApplicantKerr Dental Materials Center
Decision Date2001-09-06
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND SOLO PLUS 3 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 2001-09-06 under 510(k) number K011908. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIBOND SOLO PLUS 3?

OPTIBOND SOLO PLUS 3 is a medical device that received FDA 510(k) clearance on 2001-09-06. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K011908.

When did OPTIBOND SOLO PLUS 3 receive FDA 510(k) clearance?

OPTIBOND SOLO PLUS 3 received FDA 510(k) clearance on 2001-09-06, under 510(k) number K011908.

Who is the listed applicant for OPTIBOND SOLO PLUS 3?

The FDA 510(k) record lists Kerr Dental Materials Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIBOND SOLO PLUS 3?

The FDA product code for OPTIBOND SOLO PLUS 3 is EBC.

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Other records listing Kerr Dental Materials Center 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.

K050984BIOPLANTK031444OPTIBOND FLK030646BELLEGLASS POINT 4K020303XR PRIMER 2K020178BELLEGLASS HP MODELING GELK014027OPTIBOND SOLO PLUS 4

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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