PONTIC PAINT

K130237 · Reliance Orthodontic Products, Inc. · NXC · Apr 5, 2013 · Dental

Device Facts

• Record ID: K130237
• Device Name: PONTIC PAINT
• Applicant: Reliance Orthodontic Products, Inc.
• Product Code: NXC · Dental
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2

Indications for Use

The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.

Device Story

Pontic Paint is a light-cure coloring agent applied to thermoplastic aligners to simulate the appearance of a natural tooth. The device is supplied in a jar and applied by a dental professional using a brush. Upon application, the material is polymerized using an LED light source. It bonds chemically to the thermoplastic aligner surface. The output is a Vita-shaded (A1, A2, or B1) aesthetic coating that masks missing tooth spaces during orthodontic treatment. Used in a clinical dental setting, it assists clinicians in providing aesthetically pleasing results for patients using clear aligner systems.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Light-cure coloring agent; supplied in jars for brush application; polymerizes via LED light source; provides Vita shades A1, A2, and B1; chemically bonds to thermoplastic aligner surfaces.

Indications for Use

Indicated for use as a light cure coloring agent for thermoplastic aligners in patients undergoing orthodontic treatment with clear aligner systems to improve the aesthetic appearance of missing teeth.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Flowtain (K083051)
• Plastic Conditioner (K880792)

Submission Summary (Full Text)

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130257

Reliance Orthodontic Products, Inc.

APR 0 5 2013

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

Section 5.0

### 510 (k) Summary

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

Reliance Orthodontic Products, Inc. 510 (k) Owners Name: 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 Pontic Paint .
- Common name Pontic Paint for Thermoplastic Aligners e
- Classification name Accessory to an orthodontic plastic bracket . (21CFR872.5470, Product Code NXC, Class II Device)

## LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCE IS CLAIMED (PREDICATE DEVICE) [807.92(a) (3)]:

- Flowtain™ with Reliance Orthodontic Products, Inc. and Plastic 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 Pontic Paint is a light cure coloring agent for thermoplastic aligners. The Pontic Paint is formulated in a viscosity that is easily mixed and bonds chemically to a typically difficult to adhere to surface, a thermoplastic aligner now common in the dental industry. This paint, upon polymerization, is in Vita Shades A1. A2, and Bl allowing the appearance of a realistic tooth under the thermoplastic aligner thereby making a missing tooth situation appear aesthetically pleasing to the patient undergoing orthodontic treatment using clear aligner systems. The light cure property of the paint allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set.

The Pontic Paint will be marketed in a jar for ease of mixing and application with a brush.

## 5.2 INTENDED USE AND POPULATION:

The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.

### 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 Pontic Paint.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

#### April 5, 2013

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

Re: K130237

Trade/Device Name: Pontic Paint Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: January 29, 2013 Received: February 7. 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.

Public Health Service

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

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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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

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 Orthodontic Products, Inc.

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 30 237

Device Name: ______________ PONTIC PAINT

Indications for Use:

The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Mary S. Runner -S.
Susan Runny, DDS, MA 2013.04.04 10:24:09
000
04'00

vision Sign-Off) Ision of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k130237

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