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FDA 510(k)

SOLOBOND PLUS

K-Number: K003153 · 2000-11-15

ApplicantVoco GmbH
Decision Date2000-11-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLOBOND PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2000-11-15 under 510(k) number K003153. 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 SOLOBOND PLUS?

SOLOBOND PLUS is a medical device that received FDA 510(k) clearance on 2000-11-15. The listed applicant is Voco GmbH. The 510(k) number is K003153.

When did SOLOBOND PLUS receive FDA 510(k) clearance?

SOLOBOND PLUS received FDA 510(k) clearance on 2000-11-15, under 510(k) number K003153.

Who is the listed applicant for SOLOBOND PLUS?

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

What is the FDA product code for SOLOBOND PLUS?

The FDA product code for SOLOBOND PLUS is KLE.

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Other records listing Voco GmbH 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.

K252073VOCO Profluorid Varnish + BioMinK261357Grandio disc multicolorK252606Bifix Veneer LC, Bifix Veneer Try-InK251390MTA vptK251239GrandioSO UnlimitedK231817AlignerFlow LC

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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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