← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K990699 # ORTHO-GLOW GLITTER (K990699) _Harry J. Bosworth Co. · EBI · May 17, 1999 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K990699 ## Device Facts - **Applicant:** Harry J. Bosworth Co. - **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md) - **Decision Date:** May 17, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3760 - **Device Class:** Class 2 - **Review Panel:** Dental ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it. 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 {1}------------------------------------------------ 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ Page 1 of 1 510(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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ============================================================================================================================================================================== ssaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------| | Prescription Use
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(Optional Format 1/2/9) | | Checkmark | | | | Signature | | | | (Division Sign-Off) | | | | Division of Dental, Infection Control,
and General Hospital Devices | | | eral Hospital **Devices** KGaA ugnog 510(k) Number_ Over-the-Counter Use √ (Optional Format 1/2/96) CONFIDENT --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K990699](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K990699) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com