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FDA 510(k)

DENTOETCH QUICKBOND BOND ACTIVATOR

K-Number: K122522 · 2013-03-19

ApplicantItena Clinical
Decision Date2013-03-19
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTOETCH QUICKBOND BOND ACTIVATOR is the device name listed in this FDA 510(k) record. The listed applicant is Itena Clinical. It received FDA 510(k) clearance on 2013-03-19 under 510(k) number K122522. 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 DENTOETCH QUICKBOND BOND ACTIVATOR?

DENTOETCH QUICKBOND BOND ACTIVATOR is a medical device that received FDA 510(k) clearance on 2013-03-19. The listed applicant is Itena Clinical. The 510(k) number is K122522.

When did DENTOETCH QUICKBOND BOND ACTIVATOR receive FDA 510(k) clearance?

DENTOETCH QUICKBOND BOND ACTIVATOR received FDA 510(k) clearance on 2013-03-19, under 510(k) number K122522.

Who is the listed applicant for DENTOETCH QUICKBOND BOND ACTIVATOR?

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

What is the FDA product code for DENTOETCH QUICKBOND BOND ACTIVATOR?

The FDA product code for DENTOETCH QUICKBOND BOND ACTIVATOR is KLE.

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Other records listing Itena Clinical 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.

K170207ObturysK162960TotalC-RamK122551PROVITEMPK122521PREVENT SEALK122549DENTO TEMPK121804PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM

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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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