DMRC Self-Cure Bracket Adhesive One Step and Primer

K142886 · Danville Materials, LLC · DYH · Mar 18, 2015 · Dental

Device Facts

• Record ID: K142886
• Device Name: DMRC Self-Cure Bracket Adhesive One Step and Primer
• Applicant: Danville Materials, LLC
• Product Code: DYH · Dental
• Decision Date: Mar 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure

Device Story

DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin-based, no-mix adhesive system; used by orthodontists for direct bonding of orthodontic brackets to tooth enamel. Device functions via chemical self-curing mechanism; eliminates need for manual mixing of adhesive components. Applied by clinician to bracket and tooth surface to facilitate orthodontic treatment. Provides mechanical bond strength sufficient for clinical orthodontic applications; benefits patient by simplifying bracket placement procedure and reducing chair time.

Clinical Evidence

Bench testing only. Comparative testing against ORMCO SYSTEM 1+ included Vicker's Hardness (37 vs 29), Shear Bond Strength on enamel (6.7 MPa vs 5.2 MPa), and Self-Cure Set Time (2:30 min vs 2:00 min). Biocompatibility confirmed via cytotoxicity testing (ISO 10993-5, 2009; ISO 10993-12, 2012), with device extract found to be non-cytotoxic.

Technological Characteristics

Resin-based adhesive; self-curing chemical mechanism; no-mix formulation. Biocompatibility tested per ISO 10993-5 and ISO 10993-12. No specific ASTM standards cited for physical performance testing.

Indications for Use

Indicated for patients of all ages requiring direct bonding of orthodontic brackets to tooth structure.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• ORMCO SYSTEM 1+ (K941015)

Submission Summary (Full Text)

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

March 18, 2015

Danville Materials, LLC. Ms. Dong Hua Regulatory Affairs Director and QA Manager 3420 Fostoria Way, Suite A200 San Ramon, California 94583

Re: K142886

> Trade/Device Name: DMRC Self-cure Bracket Adhesive One Step and Primer Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: Class II Product Code: DYH Dated: February 18, 2015 Received: February 20, 2015

Dear Ms. Hua,

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, listing 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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Page 2 - Ms. Dong Hua

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

# K142886

Device Name

DMRC Self-Cure Bracket Adhesive One Step and Primer

Indications for Use (Describe)

This device is a one step no-mix adhesive for direct bonding of orthodontic bracket to tooth structure

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a square graphic on the left with a stylized design resembling a starburst or radiating lines. To the right of the graphic is the word "Danville" in a bold, sans-serif font. Below "Danville" are the words "ENGINEERING & MATERIALS" in a smaller, sans-serif font.

www.danvillematerials.com 3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

# 510(K) Summary

This summary of the Traditional 510(K) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92

#### A. Applicant's Name and Address

- A Danville Materials LLC Name:
- A Address: 3420 Fostoria Way Suite A-200 San Roman, CA 94583 USA
- A Contact Person: Dong Hua
- A Title: Regulatory Affair Director and QA Manager
- A 800-827-7940/925-973-0710. Ext. 212 Phone:
- > Fax: [phone]
- > Date Summary Prepared: March 9, 2015

#### B. The Name of the Device:

- A Trade/Proprietary Name: DMRC Self-Cure Bracket Adhesive One Step and Primer
- A The common name of the device: Dental adhesive, bracket and tooth conditioner, Resin
- A The Classification Name: Bracket adhesive resin and tooth conditioner per 21 CFR 872.3750, product Code DYH has been classified under section 513 of the Act as a Class II device

#### C. Legally Marketed Predicate Device to Which Substantial Equivalence (SE) is claimed: A K941015 ORMCO SYSTEM 1+ (TM) By ORMCO CORP

#### D. Description of the Device:

The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step. This product can be used for patients of all ages.

#### E. Indication For Use:

The DMRC Self-Cure Bracket Adhesive One Step and Primer is a one step, no mix adhesive for direct bonding of orthodontic bracket to tooth structure

### F. A comparison of the ORMCO SYSTEM 1+ (TM) by ORMCO CORP and the DMRC Self-Cure Bracket Adhesive One Step and Primer to determine SE:

- A The equivalence to the predicate device is supported by the physical performance

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Image /page/4/Picture/0 description: The image is a logo for Danville Engineering & Materials. The logo features a square graphic on the left side, which contains a stylized image of what appears to be a sun or starburst. To the right of the graphic is the word "Danville" in a bold, sans-serif font. Below "Danville" are the words "ENGINEERING & MATERIALS" in a smaller, sans-serif font.

## www.danvillematerials.com

3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

testing

- Chemicals, function of each component of the product are identified A
- A Similarities in the Indications for Use:

| Product | 510(K)<br>Number | Classification Name | Indications For Use |
|-----------------------------------------------------------|------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| ORMCO SYSTEM 1+ (TM) | K941015 | Adhesive, Bracket and<br>Tooth Conditioner,<br>Resin | Self-Cure orthodontic bracket adhesive<br>used with a liquid primer and enamel<br>etching gel to adhere orthodontic<br>brackets to tooth surfaces |
| DMRC Self-Cure Bracket<br>Adhesive One Step and<br>Primer | New<br>(K142886) | Adhesive, Bracket and<br>Tooth Conditioner,<br>Resin | A one step no-mix adhesive for direct<br>bonding of orthodontic bracket to tooth<br>structure |

- A Discussion of Non-Clinical and Clinical Tests performed for Determination of Substantial Equivalence:
The DMRC Self-Cure Bracket Adhesive One Step and Primer is a resin based adhesive designed for direct bonding of orthodontic brackets with no-mix step. The materials used in The DMRC Self-Cure Bracket Adhesive One Step and Primer are the same as used by our predicate, ORMCO SYSTEM 1+ (TM) By ORMCO CORP (K941015), which is the similar dental adhesive product. The raw chemical materials have been widely used by numerous manufacturers in the medical/dental industry.

Non-Clinical Testing performed on the DMRC Self-Cure Bracket Adhesive One Step and Primer included the following:

- Vicker's Hardness
- . Shear Bond Strength on enamel (MPa)
- . Self-Cure Set Time (Min)

There is no specific standard is used. Results of our bench testing indicate that DMRC Self-Cure Bracket Adhesive One Step and Primer was equivalent to the predicate device.

| Test Method | DMRC Self-Cure Bracket<br>Adhesive and Primer | System 1+ and Activator<br>(Ormco) |
|----------------------------------------|-----------------------------------------------|------------------------------------|
| Vicker's Hardness | 37 (5) | 29 (3) |
| Shear Bond Strength on<br>enamel (MPa) | 6.7 (1) | 5.2 (0.7) |
| Self-Cure Set Time (min) | 2:30 | 2:00 |

The subject device was determined to be substantial equivalent to the predicate in terms of biocompatibility, based on a risk assessment and the identification of legally marketed predicate devices for all ingredients in the chemical composition, as well as cytotoxicity testing

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Image /page/5/Picture/0 description: The image contains the logo for Danville Engineering & Materials. The logo features a square graphic on the left with a stylized sun or starburst design inside. To the right of the graphic, the word "Danville" is written in a bold, sans-serif font, and below that, the words "ENGINEERING & MATERIALS" are written in a smaller, sans-serif font.

www.danvillematerials.com

3420 Fostoria Way Suite A-200 San Ramon, CA 94583 USA

of device extract performed according to ISO 10993-5, 2009 and ISO 10993-12, 2012. The device extract was found to be not cytotoxic.

#### Conclusion: G.

In conclusion, the subject device, the DMRC Self-Cure Bracket Adhesive One Step and Primer has been designed and manufactured with the intended use and claims for the product in mind. The bench testing contained in our submission demonstrates that there are no differences in their technological characteristics, thereby not raising any new issues of safety or effectiveness. The DMRC Self-Cure Bracket Adhesive One Step and Primer is as safe and effective as the predicate device, and may be released to the market.