(29 days)
Not Found
Not Found
No
The summary describes a chemical primer for orthodontic bonding and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an enhancing primer for orthodontic bonding, not as a device used to treat a disease or condition.
No
The device is described as an "enhancing primer" and "universal primer" for orthodontic bonding. Its function is to facilitate the bonding of brackets, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "universal primer" and mentions components like "Solo Plus Ortho Primer A" and "Solo Plus Ortho Primer B," indicating it is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an enhancing primer for labial and lingual orthodontic bonding." This describes a product used in the mouth to prepare tooth surfaces for bonding orthodontic brackets.
- Device Description: The description confirms it's a "universal primer for labial and lingual bonding of ceramic or metal brackets." This further reinforces its use in a clinical setting for a dental procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of Solo Plus Ortho does not involve any of these activities.
Therefore, Solo Plus Ortho is a dental material used for bonding orthodontic brackets, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Solo Plus Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
Product codes
DYH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 (714) 516-7484 - Phone (714) 516-7488 - 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.
1
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.
2
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 (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 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 (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
! 4
Section I - Indications for Use
510(k) Number:
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)