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FDA 510(k)

MODIFICATION TO EXCITE

K-Number: K011490 · 2001-06-27

ApplicantIvoclar North America, Inc.
Decision Date2001-06-27
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO EXCITE is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K011490. 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 MODIFICATION TO EXCITE?

MODIFICATION TO EXCITE is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K011490.

When did MODIFICATION TO EXCITE receive FDA 510(k) clearance?

MODIFICATION TO EXCITE received FDA 510(k) clearance on 2001-06-27, under 510(k) number K011490.

Who is the listed applicant for MODIFICATION TO EXCITE?

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

What is the FDA product code for MODIFICATION TO EXCITE?

The FDA product code for MODIFICATION TO EXCITE is KLE.

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Other records listing Ivoclar North America, Inc. 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011023D.SIGN 96K011022BIOUNIVERSAL PDFK010381D.SIGN 30

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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

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

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