(87 days)
Solo Ortho 2 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 2 can be used with either chemical or light cured adhesive systems.
This document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Solo Ortho 2," an orthodontic bonding primer. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study to prove acceptance criteria using the specified structure for AI/ML medical devices. Therefore, I cannot generate the requested table and information based on the provided text.
The document is primarily a regulatory submission for premarket notification to the FDA, asserting that Solo Ortho 2 is substantially equivalent to a previously marketed device (Solo Plus Ortho). It does not contain information about:
- Specific acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity).
- A "study" designed to meet such criteria with reported device performance.
- Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML device.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details for an AI/ML model.
In summary, the provided text describes a traditional medical device (an orthodontic primer) and its regulatory submission, which is not an AI/ML device, and thus does not contain the information required to fill out the requested table and answer the study-specific questions.
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Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.
Ka943ca
· Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Wendy Urtel - Contact Person
Date Summary Prepared: December 1999
Device Name:
- Trade Name Solo Ortho 2 .
- Common Name Orthodontic Bonding Primer ●
- Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § 872.3750 .
Device for Which Substantial Equivalence is Claimed:
- Solo Plus Ortho Ormco Corporation .
Device Description:
The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 2 can be used with either chemical or light cured adhesive systems.
Intended Use of the Device:
The intended use of Solo Ortho 2 is as an enhancing primer for labial and lingual orthodontic bonding.
Substantial Equivalence:
Solo Ortho 2 is substantially equivalent to other legally marketed devices in the United States. Solo Ortho 2 functions in a manner similar to and is intended for the same use as the product Solo Plus Ortho cleared for marketing for Ormco Corporation.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2000
Ms. Wendy Urtel Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re : K994309 Trade Name: Solo Ortho 2 Regulatory Class: II Product Code: DYH Dated: December 16, 1999 Received: December 21, 1999
Dear Ms. Urtel:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Urtel
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 diagnostic 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" (21 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section I - Indications for Use
510(k) Number: K994309
Solo Ortho 2 Device Name:
Indications for Use:
Solo Ortho 2 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
UNDE
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices rag 42 510(k) Number .
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
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.(b)
Classification. Class II.