DENTOETCH QUICKBOND BOND ACTIVATOR

K122522 · Itena Clinical · KLE · Mar 19, 2013 · Dental

Device Facts

• Record ID: K122522
• Device Name: DENTOETCH QUICKBOND BOND ACTIVATOR
• Applicant: Itena Clinical
• Product Code: KLE · Dental
• Decision Date: Mar 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

DentoEtch is 37% phosphoric acid etching gel. Quickbond is a two-bottle, two-step self-etching bonding system (primer and bonding agent). Bond Activator enables self-cure techniques for dual-cured adhesive applications. Used by dental practitioners in clinical settings for restorative procedures. Products applied to tooth surfaces to facilitate adhesion of restorative materials or seal cavities. Benefits include improved retention of dental restorations and treatment of tooth sensitivity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed; results interpreted as moderate-severe and none, validating the test.

Technological Characteristics

DentoEtch: 37% phosphoric acid gel. Quickbond: Two-bottle, two-step self-etching resin bonding system. Bond Activator: Chemical additive for self-cure/dual-cure functionality. Materials are standard dental resins and acids. No electronic components or software.

Indications for Use

Indicated for dental patients requiring enamel/dentin etching, bonding of restorative materials (composites, veneers, crowns, bridges, inlays, onlays), composite core build-ups, metal bonding, intraoral repairs, treatment of hypersensitive teeth/exposed roots, and cavity sealing under amalgam.

Regulatory Classification

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.

Predicate Devices

• Kerr Gel Etchant (K000954)
• Premier Self-Etching Bond Enhancer (K061998)
• Clearfil SE Bond (K023842)
• Prime and Bond NT (K982394)
• Prime & Bond Activator (K964525)
• Bond-1 Self-Cure Activator (K013543)

Submission Summary (Full Text)

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K | 22.522

Itena Clinical

# 510(k) Summary

MAR 1 9 2013

1. Name/Address of Submitter:

Contact Person:

2.

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 Etchant<br>K000954 | | |
|----------------|------------------------------------------------------------|-------------------------------------------|------------------------------------|
| Quickbond | Premier<br>Self-<br>Etching<br>Bond<br>Enhancer<br>K061998 | Clearfil<br>SE Bond<br>K023842 | Prime<br>and<br>Bond NT<br>K982394 |
| Bond Activator | Prime & Bond<br>Activator<br>K964525 | Bond-1 Self-<br>Cure Activator<br>K013543 | |

#### 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