(88 days)
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No
The description focuses on the chemical composition and adhesive properties of a dental primer, with no mention of AI or ML capabilities.
No.
The device is used as an enhancing primer and adhesive for orthodontic bonding, which is a supportive rather than a therapeutic function (i.e., treating or preventing a disease).
No
The device is described as an adhesive primer for orthodontic bonding, an all-purpose dental adhesive, and a universal primer. Its function is to facilitate bonding, not to diagnose conditions or diseases.
No
The device description clearly states it is a "visible light curable methacrylate resin based mixture of monomers," which is a physical 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 device used in vivo (on a living patient) to facilitate the bonding of orthodontic brackets to teeth.
- Device Description: The description details a dental adhesive applied to tooth structure and restorative materials. This is a direct application within the mouth, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose, monitor, or screen for diseases or conditions. The provided information does not mention any such use or analysis of biological samples.
Therefore, the device described is a dental adhesive used in a clinical setting for orthodontic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Solo Ortho is as an enhancing primer for labial and lingual orthodontic bonding.
Solo Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
Product codes
DYH
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 _