(75 days)
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.
Not Found
I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification letter from the FDA to the Harry J. Bosworth Company for a device called "Ortho-Glow Glitter."
The letter states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a test set, its sample size, or data provenance.
- Information about experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone algorithm-only performance study.
- The type of ground truth used.
- The sample size for the training set or how its ground truth was established.
The "INDICATIONS FOR USE" section describes the intended purpose of the product as a "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." This suggests that the device's primary function is decorative, and the FDA's substantial equivalence determination for such a product typically focuses on material safety and compatibility, rather than complex performance metrics that would require the kinds of detailed studies you've asked about.
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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
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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 (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
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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.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use(Optional Format 1/2/9) |
| (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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.