(88 days)
Solo Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
The device is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structure, e.g., enamel and dentin, to commonly used restorative materials, e.g., composite resins, porcelain and metals. Due to the chemistry of this device is also suitable as a universal primer for labial and lingual bonding of ceramic or metal brackets.
This document is a 510(k) summary for the Solo Ortho orthodontic bonding primer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met is not available in the provided text.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not provided. The document focuses on substantial equivalence based on similar function and intended use, not on specific performance metrics or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No performance study data is presented. The substantial equivalence claim is based on the device description and intended use being similar to a predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No performance study data is presented.
4. Adjudication Method for the Test Set:
Not applicable. No performance study data is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. An MRMC study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical orthodontic bonding primer, not an algorithm or AI.
7. The Type of Ground Truth Used:
Not applicable. No ground truth is established as no performance study is described. The basis for substantial equivalence is comparison to a predicate device for intended use and function.
8. The Sample Size for the Training Set:
Not applicable. No training set is mentioned as this is a physical device and not an AI/ML product.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set or ground truth for a training set is mentioned.
{0}------------------------------------------------
JUN 4 1999
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.
SYBRON DENTAL SPECIALTIES
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 Colleen Boswell - Contact Person
Date Summary Prepared: March 1999
Device Name:
- . Trade Name - Solo Ortho
- Common Name Orthodontic Bonding Primer .
- Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 21 CFR § 872.3750 .
Devices for Which Substantial Equivalence is Claimed:
- . Ormco Corporation, Solo Plus Ortho
Device Description:
The device is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structure, e.g., enamel and dentin, to commonly used restorative materials, e.g., composite resins, porcelain and metals. Due to the chemistry of this device is also suitable as a universal primer for labial and lingual bonding of ceramic or metal brackets.
Intended Use of the Device:
The intended use of Solo Ortho is as an enhancing primer for labial and lingual orthodontic bonding.
Substantial Equivalence:
Solo Ortho is substantially equivalent to other legally marketed devices in the United States. The orthodontic bonding primer marketed by Ormco Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 4
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue 92867 Orange, California
K990743 Re : Trade Name: Solo Ortho Regulatory Class: II Product Code: DYH March 5, 1999 Dated: March 8, 1999 Received:
Dear Ms. Boswell:
We have reviewed your Section 510(k) notification of intent to we have the device referenced above and we have determined the market is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate ase stated in the choises is , the enactment date of the Medical Device Amendments, or to devices that have been realeas ified 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 The general controls provisions of the Act 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. ਮੈ 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.
{2}------------------------------------------------
Page 2 - Ms. Boswell
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 requlation (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
{3}------------------------------------------------
Section I - Indications for Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number:
Device Name: Solo Ortho
Indications for Use:
Solo Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
:1
Susan Purora
、ア
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 16990742 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.