ORTHO-GLOW GLITTER

K990699 · Harry J. Bosworth Co. · EBI · May 17, 1999 · Dental

Device Facts

• Record ID: K990699
• Device Name: ORTHO-GLOW GLITTER
• Applicant: Harry J. Bosworth Co.
• Product Code: EBI · Dental
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Decorative additive for acrylic resin systems to add glitter and/or metallic appearance and/or artistic shapes/designs to orthodontic retainers, and other orthodontic appliances and to dentures, splints, and mouth guards.

Device Story

Ortho-Glow Glitter is a decorative additive incorporated into acrylic resin systems during the fabrication of dental appliances. It provides a metallic or glitter appearance or artistic designs to orthodontic retainers, dentures, splints, and mouth guards. The device is intended for use by dental professionals or laboratory technicians during the appliance manufacturing process. It does not alter the structural integrity of the acrylic resin but serves an aesthetic purpose for the patient.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Decorative additive for acrylic resin systems. Form factor is a particulate or additive material. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for use as a decorative additive in acrylic resin systems for orthodontic retainers, orthodontic appliances, dentures, splints, and mouth guards.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 1999

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

Re : K990699 Ortho-Glow Glitter Trade Name: Requlatory Class: II Product Code: EBI February 23, Dated: ਹੈ ਰੇ ਰੇ Received: March 3, 1999

Dear Ms. Goldstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Goldstein

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Divisibn of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number:

Device Name: Ortho-Glow Glitter - Gold or Silver

## INDICATIONS FOR USE:

Decorative additive for acrylic resin systems to add glitter and/or metallic appearance and/or artistic shapes/designs to orthodontic retainers, and other orthodontic appliances and to dentures, splints, and mouth guards.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-the-Counter Use<br>(Optional Format 1/2/9) |
| <img alt="Checkmark" height="20" src="checkmark.png" width="20"/> | | |
| <img alt="Signature" height="50" src="signature.png" width="150"/> | | |
| (Division Sign-Off) | | |
| Division of Dental, Infection Control,<br>and General Hospital Devices | | |

eral Hospital **Devices**
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ugnog 510(k) Number_

Over-the-Counter Use √ (Optional Format 1/2/96)

CONFIDENT