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FDA 510(k)

EXCITE F AND EXCITE DSC

K-Number: K093744 · 2010-03-10

ApplicantIvoclar Vivadent, Inc.
Decision Date2010-03-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCITE F AND EXCITE DSC is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K093744. 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 EXCITE F AND EXCITE DSC?

EXCITE F AND EXCITE DSC is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K093744.

When did EXCITE F AND EXCITE DSC receive FDA 510(k) clearance?

EXCITE F AND EXCITE DSC received FDA 510(k) clearance on 2010-03-10, under 510(k) number K093744.

Who is the listed applicant for EXCITE F AND EXCITE DSC?

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

What is the FDA product code for EXCITE F AND EXCITE DSC?

The FDA product code for EXCITE F AND EXCITE DSC is KLE.

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Other records listing Ivoclar Vivadent, 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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