DENTOETCH QUICKBOND BOND ACTIVATOR

• K Number: K122522
• Device Name: DENTOETCH QUICKBOND BOND ACTIVATOR
• Manufacturer: ITENA CLINICAL
• Date Cleared: 2013-03-19 ( 211 days)
• Product Code: KLE , EBF
• Regulation Number: 872.3200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K000954 , K061998 , K023842 , K982394 , K964525 , K013543
• Predicate For: N/A

Intended Use

DentoEtch: It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.
Quickbond: It is intended for: Bonding composite to enamel and/or dentin; Bonding veneers, crowns & bridges, onlays and inlays; Bonding composite core built-up material; Bonding of composite to metal, Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers); Treatment of hypersensitive teeth or exposed root surfaces; and Cavity sealing under amalgam restorations
Bond Activator: It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.

Device Description

DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.
Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator

AI/ML Overview

The provided text is related to a 510(k) summary for dental devices (DentoEtch, Quickbond, and Bond Activator) and does not contain information about a study proving that a device meets specific acceptance criteria in the context of AI/ML performance testing for medical image analysis or similar diagnostic tools. The document describes the devices, their classification, predicate devices, and indications for use, as well as the FDA's clearance of the devices based on substantial equivalence to existing products.

Therefore, for almost all points requested, the information is not present in the provided text, as the context is a traditional medical device clearance, not an AI/ML diagnostic tool.

Here's how the information maps to the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) summary focuses on substantial equivalence based on indications for use and technological characteristics, not on quantifiable performance metrics of an AI/ML system.
2. Sample sizes used for the test set and the data provenance: Not present. This type of detail is not typically included in a 510(k) summary for these types of dental devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. Ground truth establishment for AI/ML models is not relevant to this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This type of study is relevant for AI/ML-assisted diagnostic tools, not for dental bonding agents and etchants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Not applicable to these devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only "performance" or "test" information mentioned is:

• "cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test." This is a very brief and high-level statement, likely referring to biocompatibility testing, which is standard for medical devices, but it does not provide acceptance criteria or detailed performance data in the way an AI/ML study would. It serves only to state that a test was performed and validated the product.

Summary

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K | 22.522

Itena Clinical

510(k) Summary

MAR 1 9 2013

1. Name/Address of Submitter:

Contact Person:

Louis-Paul Marin Co-President, BCF Certification inc. Phone: [phone] [phone] Fax: Email: [e-mail]

July 24, 2012 3. Date Summary Prepared:

• Devices Names: DentoEtch, Quickbond and Bond Activator 4. 5. Device Classification: II
• 6. Common name: Etching Gel and Resin tooth bonding agents
• 7. Classification Product Code: EBF (21 CFR 872.3690) and KLE (21 CFR 872.3200)
• 8. Predicate Devices:

DentoEtch	Kerr Gel EtchantK000954
Quickbond	PremierSelf-EtchingBondEnhancerK061998	ClearfilSE BondK023842	PrimeandBond NTK982394
Bond Activator	Prime & BondActivatorK964525	Bond-1 Self-Cure ActivatorK013543

9. Devices Description:

DentoEtch: DentoEtch is an etching gel phosphoric acid 37%.

Quickbond: Simple to use, two-bottle, two step self-etching bonding system, with a first bottle containing the primer and a second one containing the bonding agent. This subject device may also be used with a self-curing activator

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resulted in cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test.

• Conclusion Drawn: Based on their indications for use, technological 12. characteristics and comparison to predicate devices, the subject devices have been shown to be safe and effective for their intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 19, 2013

Itena Clinical C/O Mr. Louis-Paul Marin Co-President BCF Certification Incorporated 500 Boul Cartier West Laval, Canada H7V 5B7

Re: K122522

Trade/Device Name: Quickbond , Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 15, 2013 Received: February 11, 2013

Dear Mr. Marin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K12252z

Indication for Use

Device Name: DentoEtch

Indication for Use:

It is intended used for etching tooth enamel and dentine when preparing surfaces for application of composites.

Device Name: Quickbond

Indication for Use:

It is intended for:

• · Bonding composite to enamel and/or dentin;
• · Bonding veneers, crowns & bridges, onlays and inlays
• · Bonding composite core built-up material
• · Bonding of composite to metal,
• · Intraoral repairs (i.e. composite, fractured crowns & bridges, inlays & onlays and veneers);
• · Treatment of hypersensitive teeth or exposed root surfaces; and
• · Cavity sealing under amalgam restorations

Device Name: Bond Activator

It is intended for use to enable the practitioner to use self-cure techniques for the indications where dual-cured adhesive may be desired.

Concurrence of CDRH Office of Device Evaluation

l - I

Prescription Use X	OR
801.109)

Susan Runner, DDS, MS
Mary S. Runner -S
2013.03.15

10:20:07 -04'00'

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

(per 21 CFR

x122 522

510(k) Number:_

Over-the-counter Use

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.