(76 days)
Not Found
Not Found
No
The summary describes a chemical primer for orthodontic bonding and makes no mention of AI or ML technology.
No
The device is a primer for orthodontic bonding, not a device directly involved in the treatment or therapy of a condition.
No
The device is described as an "enhancing primer for labial and lingual orthodontic bonding" and a "one-bottle, universal primer." Its function is to facilitate the bonding of orthodontic brackets, not to diagnose a condition or disease.
No
The device description clearly states it is a "one-bottle, universal primer," indicating 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 product used in the mouth to prepare tooth surfaces for bonding orthodontic brackets.
- Device Description: The description confirms it's a "one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets." This further reinforces its use in a clinical setting on a patient.
- 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 Ortho 3 does not involve any of these activities.
Therefore, Solo Ortho 3 is a dental material used directly on the patient's teeth, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of Solo Ortho 3 is as an enhancing primer for labial and lingual orthodontic bonding.
Solo Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
Product codes
DYH
Device Description
The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 3 can be used with either chemical or light cured adhesive systems.
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)
Ormco Corporation, Solo Ortho 2
Reference Device(s)
Not Found
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
K.030502
SYBRON DENTAL SPECIALTIES
MAY 0-1 2002
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: February 2002
Device Name:
- Trade Name Solo Ortho 3 .
- 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 Ortho 2 .
Device Description:
The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 3 can be used with either chemical or light cured adhesive systems.
Intended Use of the Device:
The intended use of Solo Ortho 3 is as an enhancing primer for labial and lingual orthodontic bonding.
Substantial Equivalence:
Solo Ortho 3 is substantially equivalent to other legally marketed devices in the United States. Solo Ortho 3 functions in a manner identical to and is intended for the same use as the product Solo Ortho 2 cleared for marketing for Ormco Corporation.
1717 West Collins Avenue, Orange, CA 92887 800-537-7824 714-516-7400
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K020502
Trade/Device Name: Solo Ortho 3 Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: February 11, 2002 Received: February 14, 2002
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendor ents, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the readeral F ocat, Drag, Drag, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wr ), it an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
Image /page/1/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAY 01 2002
2
Page 2 - Ms. Colleen Boswell
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613_ 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kichards
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 Statement
Ver/ 3 - 4/24/96
Applicant: Ormco Corporation
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K020502 |
Device Name: Solo Ortho 3
Indications For Use:
Solo Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Labels | Values |
|---|---|
| 510(k) Number | K020502 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)