SOLO PLUS ORTHO

• K Number: K990252
• Device Name: SOLO PLUS ORTHO
• Manufacturer: SYBRON DENTAL SPECIALTIES, INC.
• Date Cleared: 1999-02-25 ( 29 days)
• Product Code: DYH
• Regulation Number: 872.3750
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Solo Plus Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

Device Description

The device is a universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Plus Ortho may be light cured, using Solo Plus Ortho Primer A, or chemical cured using Solo Plus Ortho Primer A and Solo Plus Ortho Primer B.

AI/ML Overview

I am sorry, but the provided text Kaa052 does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a dental product called "Solo Plus Ortho," seeking substantial equivalence to existing devices. It focuses on device description, intended use, and regulatory classification, not on performance studies with specific statistical metrics.

Therefore, I cannot extract the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Results of any MRMC comparative effectiveness study.
• Results of any standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Summary

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Kaa052

SYBRON DENTAL SPECIALTIES Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: January 1999

Device Name:

• Trade Name Solo Plus 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:

• . Unitek Corporation/3M, Transbond MIP Moisture Insensitive Primer

Device Description:

The device is a universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Plus Ortho may be light cured, using Solo Plus Ortho Primer A, or chemical cured using Solo Plus Ortho Primer A and Solo Plus Ortho Primer B.

Intended Use of the Device:

The intended use of Solo Plus Ortho is as an enhancing primer for labial and lingual orthodontic bonding.

Substantial Equivalence:

Solo Plus Ortho is substantially equivalent to other legally marketed devices in the United States. The orthodontic bonding primer marketed by Unitek Corporation/3M functions in a manner similar to and is intended for the same use as the product manufactured by Ormco Corporation.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1999

Colleen Boswell MS. Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

K990252 Re : Solo Plus Ortho Trade Name: Requlatory Class: II Product Code: DYH Dated: January 25, 1999 January 27, 1999 Received:

Dear Ms. Boswell:

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, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (GMP) GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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. Boswell

This letter will allow you to begin marketing your device as Inis receir wire as on the premarket notification. The FDA described in your 510\x) privalence of your device to a legally Finding of subbeaneral ogaresults in a classification for your marketed predicate device as a so device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire bpoints and additionally 809.10 for in regulation (ar ex races), 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 the regulation choroson" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be Information of your sion of Small Manufacturers Assistance at its toll-free number [phone] or [phone] 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:

K990252

Device Name: Solo Plus Ortho

Indications for Use:

Solo Plus Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

Susan Russer

(Division :دار () ان ي د Division of Dear. It infection Control, and General H. S. ਸੀ। ਇਸਦਾਦਾਲ

510(k) Numit.: K990052

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.