CLEAR ALIGNER ADHESIVE

K123348 · Reliance Orthodontic Products, Inc. · DYH · Feb 28, 2013 · Dental

Device Facts

• Record ID: K123348
• Device Name: CLEAR ALIGNER ADHESIVE
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: DYH · Dental
• Decision Date: Feb 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

Device Story

Clear Aligner Adhesive is a light-cure orthodontic bonding resin; used to attach metal, composite, or porcelain brackets and appliances to thermoplastic aligners. Dispensed via push syringe; applied by dental professionals. Polymerization triggered by LED light source. Adhesive bonds chemically to thermoplastic surfaces; provides clear, aesthetically pleasing finish. Benefits include improved bond strength compared to traditional adhesives; facilitates secure attachment of orthodontic accessories to aligners.

Clinical Evidence

Bench testing only. Shear bond strength testing compared Clear Aligner Adhesive to Flowtain with Plastic Conditioner, demonstrating higher bond strength for the subject device. Biocompatibility testing performed via ISO 10993-5 elution test; results showed no evidence of cytotoxicity, cell lysis, or toxicity.

Technological Characteristics

Light-cure orthodontic adhesive resin. Chemical bonding mechanism to thermoplastic aligners, metal, composite, and porcelain. Supplied in push syringe. Clear appearance upon polymerization. Biocompatibility verified per ISO 10993-5.

Indications for Use

Indicated for orthodontic patients requiring bonding of brackets and appliances to thermoplastic aligner surfaces.

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

• Flowtain (K083051)
• Plastic Conditioner (K880792)

Submission Summary (Full Text)

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K123348

# ic Products. Inc.

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.

FEB 2 8 2013

# Section 5.0

#### 510 (k) Summary

Note: This summary is provided in accordance with 21CFR807.92 (c).

510 (k) Owners Name: Reliance Orthodontic Products, Inc. Paul Gange, President

Address: 1540 West Thorndale Avenue Itasca, Il 60143 USA

Phone Number: 630-773-4009 Fax Number: 630-250-7704

Paula Wendland, Regulatory Affairs Manager (Preparer) Contact Person:

Date 510 (k) Summary was Prepared: August 13, 2012

Medical Device Name:

- Trade name Clear Aligner Adhesive .
- Common name Light Cure Orthodontic Adhesive for Aligners .
- Classification name Bracket Adhesive Resin and Tooth Conditioner � (21CFR872,3750, Product Code DYH, Class II Device)

LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) 1807.92(a) (3)|:

- Flowtain™ with Reliance Orthodontic Products, Inc. and Plastic 0 Conditioner : 510(K083051 and K880792, respectively).

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Reliance Orthodontic Products, Inc.

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.

## 5.1 DESCRIPTION OF THE APPLICANTS DEVICE:

The Clear Aligner Adhesive is a light cure, orthodontic adhesive for metal, composite and porcelain brackets and appliances to bond to a thermoplastic aligner. The Clear Aligner Adhesive is formulated in a viscosity that flows easily from the syringe and bonds chemically to a typically difficult to adhere to surface. a thermoplastic aligner now common in the dental industry. This adhesive, upon polymerization, is clear and virtually indistinguishable from the thermoplastic aligner thereby making it aesthetically pleasing to the patient.

The light cure property of the adhesive allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set.

The Clear Aligner Adhesive will be marketed in a push syringe for dispensing.

#### 5.2 INTENDED USE AND POPULATION:

The Clear Aligner Adhesive is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

## 5.3 PREDICATE DEVICE:

Reliance Orthodontic Products, Inc. Flowtain and Plastic Conditioner, 510(k) submission (K083051 and 880792, respectively) dated 2/20/2009 and 1/15/1988. Flowtain and Plastic Conditioner are similar in intended use for bonding to thermoplastic aligners. Flowtain is similar in compositional basis to the Clear Aligner Adhesive.

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Reliance Orthod ic Product

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] West Thorndale Ave. · Itasca, IL · 60143 · U.S.A.

5.4 TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS:

Performance Characteristics of CLEAR ALIGNER ADHESIVE versus Flowtain with Plastic Conditioner:

| Property | Clear Aligner Adhesive | Reliance Orthodontic Products,<br>Inc. Flowtain with Plastic<br>Conditioner |
|------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | Orthodontic Bonding<br>Adhesive for Thermoplastic<br>Aligners | Orthodontic Bonding Adhesive for<br>retention of Thermoplastic<br>Aligners |
| Method of<br>Cure | Light Cure | Light Cure |
| Aesthetic<br>Features | Clear when polymerized | Shade A1 when polymerized |
| Physical<br>Properties | Chemical bond to<br>thermoplastic aligner and<br>metal, composite or<br>porcelain | Mechanical and Chemical bond to<br>thermoplastic aligner, enamel,<br>metal, composite and porcelain |

## 5.5 Summary:

Clear Aligner Adhesive was tested and compared to Reliance Orthodontic Products, Inc. Flowtain in conjunction with Plastic Conditioner for Shear Bond Strength. Testing resulted in highly increased bond strength values for the Clear Aligner adhesive when compared to the use of Flowtain with a Plastic conditioner.

Clear Aligner Adhesive has been tested for cytotoxicity via the ISO 10993-5 elution test method and showed no evidence of causing cell lysis or toxicity.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

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

February 28, 2013

Ms. Paula Wendland Regulatory Affairs Manager Reliance Orthodontic Products. Incorporated 1540 West Thorndale Avenue ITASCA IL 60143

Re: K123348

Trade/Device Name: Clear Aligner Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: January 3, 2013 Received: January 24, 2013

Dear Ms. Wendland:

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. Wendland

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 (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.

Image /page/4/Picture/6 description: The image shows the name "Kwame O. Ulmer" in bold, black font. To the right of the name is a graphic design that appears to be a stylized logo. The logo is composed of geometric shapes and lines, creating a visually interesting pattern. The overall image has a clean and professional look.

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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Reliance Orthodonlic Product

Toll Free 1-800-323-4348 · Phone [phone] · Fax [phone] West Thorndale Ave. · Itasca IL · 60143 · U.S.A.

# SECTION 6.0 INDICATIONS FOR USE STATEMENT

Indications for Use 510 (k) Number (if known): K 123348

Device Name: CLEAR ALIGNER ADHESIVE

Indications for Use:

The CLEAR ALIGNER ADHESIVE is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

Mary S. Runner -S 2013.02.27 SULDA 13:29:06 -05'00' న్నారు.
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(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

**510(k) Number:** KR2348