(63 days)
Not Found
No
The description focuses on the material properties and application of a dental cement, with no mention of AI or ML.
No.
The device is an orthodontic bonding cement used for attaching orthodontic appliances to teeth, which is a structural or supportive function rather than a therapeutic one.
No
The device is a light-cured orthodontic bonding cement for attaching orthodontic appliances to teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a resin-based fluoride releasing band cement, which is a physical material, 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 for the "attachment of orthodontic appliances to teeth." This is a direct application to the patient's body (teeth) for a therapeutic purpose (orthodontic treatment).
- Device Description: The description details a "resin-based fluoride releasing band cement" used for bonding. This is a material applied externally to the teeth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to test samples (like blood, urine, tissue) taken from the body to diagnose or monitor a condition. This device is applied to the body for treatment.
N/A
Intended Use / Indications for Use
The intended use of Optiband LC is as a light-cured orthodontic band cement that is designed for the attachment of orthodontic appliances to teeth.
Optiband LC Band Cement is a light-cured orthodontic bonding cement that is intended to be used for the attachment of orthodontic appliances to teeth.
Product codes
DYH
Device Description
The device is a resiri-based fluoride releasing band cement. It is a single paste so messy powder and liquid mixing is eliminated as well as inconsistent mixing of catalyst/activator type cements. Optiband LC achieves high strength following light cure allowing active archwires to be placed immediately. Optiband LC has higher tensile and compressive strength than glass ionomers or zinc phosphates and does not have an unpleasant taste or odor. It is specially formulated to have high adhesion to enamel and metal surfaces to reduce the chances of wash-out and loose bands. Optiband LC is offered in two shades, chromatic formula and blue formula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
3M Unitek Dental Products Division, Transbond Plus
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
OCT = 6 2003 Section III - 510(k) Summary of Safety and
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: July 2003
Device Name:
- Trade Name Optiband LC ●
- Common Name -- Orthodontic Band Cement ●
- Classification Name Bracket Adhesive Resin and Tooth Conditioner, per 2 i CFR & 872.3750 .
Devices for Which Substantial Equivalence is Claimed:
- 3M Unitek Dental Products Division, Transbond Plus .
Device Description:
The device is a resiri-based fluoride releasing band cement. It is a single paste so messy powder and liquid mixing is eliminated as well as inconsistent mixing of catalyst/activator type cements. Optiband LC achieves high strength following light cure allowing active archwires to be placed immediately. Optiband LC has higher tensile and compressive strength than glass ionomers or zinc phosphates and does not have an unpleasant taste or odor. It is specially formulated to have high adhesion to enamel and metal surfaces to reduce the chances of wash-out and loose bands. Optiband LC is offered in two shades, chromatic formula and blue formula.
Intended Use of the Device:
The intended use of Optiband LC is as a light-cured orthodontic band cement that is designed for the attachment of orthodontic appliances to teeth.
Substantial Equivalence:
Optiband LC is substantially equivalent to other legally marketed devices in the United States. Optiband LC functions in a manner similar to and is intended for the same use as Transbond Plus that is currently marketed by 3M Unitek Dental Products Division.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, composed of three curved lines. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2003
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K032407
Trade/Device Name: Optiband LC Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: July 31, 2003 Received: August 04, 2003
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 Amendments, 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 approval application (PMA). You may, 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 your device can 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.
2
Page 2 - Ms. Colleen Boswell
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. 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 requirements as set forth 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), 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) you may obtain. 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,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Section I - Indications for Use
:
| Ver/ 3 - 4/24/96 | |
|---|---|
| Applicant: | Ormco Corporation |
| 510(k) Number (if known): | K032407 |
| Device Name: | Optiband LC |
| Indications For Use: | |
| Optiband LC Band Cement is a light-cured orthodontic bonding cement that is intended to be used for the attachment of orthodontic appliances to teeth. |
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
| 510(k) Number: | K032407 |
|---|---|
| ---------------- | --------- |
(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)