(82 days)
K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement, Unitek™Multi-Cure Glass Ionomer Band Cement
No
The device description and performance studies focus on the chemical and physical properties of a dental cement, with no mention of AI or ML.
Yes
The device is used to cement orthodontic bands to teeth, which is a therapeutic intervention for dental alignment.
No
The device is a cement used for orthodontic bands, which is a treatment material, not a device used to diagnose a medical condition or disease.
No
The device description clearly states it is a "triple cure, band cement which is light blue, two-part, resin based, fluoride releasing, glass ionomer orthodontic cement," indicating it 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 to "cement all types of orthodontic bands to the teeth." This is a direct application to the patient's body for a therapeutic purpose (orthodontic treatment).
- Device Description: The description details a cement used for bonding orthodontic bands.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is a material used in a dental procedure.
N/A
Intended Use / Indications for Use
Opal® Band™ Cement uses chemical, light polymerization and glass ionomer to cement all types of orthodontic bands to the teeth.
Product codes
DYH
Device Description
Opal® Band™ Cement is a triple cure, band cement which is light blue, two-part, resin based, fluoride releasing, glass ionomer orthodontic cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
all ages
Intended User / Care Setting
dentists and orthodontists
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)
The following bench tests were conducted during the R & D phase on Opal® Band™ Cement and compared to K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement also known as " Unitek™Multi-Cure Glass Ionomer Band Cement" Final test results are in Section 18 "Bench Testing".
- a. Flexural Strength This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. Our testing shows more "give" to it as our competitor's product has more glass ionomer in it and tends to be "stiffer. We prefer the elasticity.
- b. Hardness This test shows the resiliency of the material to resist deformation. It is acceptable for us to stay ± 6.0 HK of our competitors range with water and ±14.0 HK in hardness without water as this shows the elastic properties of our cement.
- Setting Time This test determines the amount of time it takes for the product to be C. completely set. We prefer to be as close to our predicate as possible.
- d. Ambient Light Sensitivity This test shows the time that the product will cure in ambient light. It shows working time with the product and curing time of the product. We want higher times in this category.
- Sorption This test shows how much water the resin absorbs. We want low readings on this e. test. Both products show hydrophyllic properties which is indicative of their base materials.
- f. Film thickness - testing bond strength at a defined thickness.
- Radiopacity verifying how clear the product shows up during an Xray. g.
- Soluability- testing whether the product degrades in solutions or saliva. Look for a pass in this section.
- Working time The amount of time you have to work with the product before it starts to set-up i.
- Compressive Strength Measures the material's ability to not break apart under a compressive j. load. Prefer a higher number.
- Compressive Modulus This shows the amount of "give" when under force. We prefer a k. similar number to our predicate.
- Metal Shear -This test checks the ability of the product to adhere to metals. We prefer a 1. number similar to our predicate.
- m. Dimension Change Determines how much water is absorbed into the product. Two sets of measurements were recorded to validate our numbers.
- Fluoride release Tested fluoride release over 28 days and Fluoride burst on the first day. n.
- o. Fluoride Burst -First day of measurements
A complete Clinical Summary of Opal® Band™ Cement is included in Section 20. We conducted a literature study to show safety and effectiveness of Opal® Band™ Cement. The product including different sizes and shapes can be used on any age patient when treatment is prescribed by a dentist or orthodontist. The device has the same technological characteristics compared to K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement also known as " Unitek™Multi-Cure Glass Ionomer Band Cement"
These materials have been widely used by numerous manufacturers in the dental industry.
The efficacy or suitability to the intended purpose of Opal® Band™ Cement has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicates that Opal® Band™ Cement performs as well or better than the predicate device currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KIII696
Section 5
SEP - 7 2011
Traditional 510(k) Summary
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 .92.
Applicant's Name and Address
Opal Orthodontics by Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
| Contact Person: | |
|---|---|
| Title: | |
| Telephone: | |
| FAX: | |
| Date Summary Prepared: |
Diane Rogers Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 June 14, 2011
Name of the Device
.
Trade Name: Common Name: Device Classification: Classification Product Code: Opal® Band™ Cement Adhesive, Bracket and Tooth Conditioner, Resin ll DYH
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is: K950514 GC/3M Tri-Cure Glass lonomer Orthodontic Band Cement also known as " Unitek™Multi-Cure Glass Ionomer Band Cement"
Opal® Band™ Cement is very similar to our predicate device in that both devices are intended to be used to cement orthodontic bands on to teeth. There are several other products in the market that have the same indications as these products. We chose Unitek™ Multi-Cure Glass Ionomer Band Cement as it tested the most similar to Opal®Band™ Cement.
Indications for Use: Opal® Band™ Cement uses chemical, light and glass ionomer polymerization to cement all types of orthodontic bands to the teeth.
1
Product Description: Opal® Band™ Cement is a triple cure, band cement which is light blue, two-part, resin based, fluoride releasing, glass ionomer orthodontic cement.
Opal® Band™ Cement is a triple cure, fluoride releasing, permanent band cement used by dentists and orthodontists to cement a variety of bands and sizes of bands onto teeth. Orthodontic bands are indicated for patients of all ages that a dentist or orthodontist deems necessary for treatment.
Similarities in the Indications for Use
| Opal® Band™ Cement | | Opal® Band™ Cement uses
chemical, light and glass
ionomer polymerization to
cement all types of
orthodontic bands to the
teeth. |
|-------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Unitek™ Multi-Cure Glass
Ionomer Band Cement | K950514 | Unitek™ Multi-Cure Glass
Ionomer Orthodontic Band
Cement is a two-part
powder/liquid glass ionomer
cement for orthodontic
banding. |
Opal® Band™ Cement is supplied in a pre-mixed syringe for easy delivery and no waste.
Unitek™ Multi-Cure Glass Ionomer Band Cement is supplied in bottles of liquid and powder that need to be mixed in a dish prior to use.
Brief Description of Testing Performed
The following bench tests were conducted during the R & D phase on Opal® Band™ Cement and compared to K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement also known as " Unitek™Multi-Cure Glass lonomer Band Cement" Final test results are in Section 18 "Bench Testing".
- a. Flexural Strength This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. Our testing shows more "give" to it as our competitor's product has more glass ionomer in it and tends to be "stiffer. We prefer the elasticity.
5
2
- b. Hardness This test shows the resiliency of the material to resist deformation. It is acceptable for us to stay ± 6.0 HK of our competitors range with water and ±14.0 HK in hardness without water as this shows the elastic properties of our cement.
- Setting Time This test determines the amount of time it takes for the product to be C. completely set. We prefer to be as close to our predicate as possible.
- d. Ambient Light Sensitivity This test shows the time that the product will cure in ambient light. It shows working time with the product and curing time of the product. We want higher times in this category.
- Sorption This test shows how much water the resin absorbs. We want low readings on this e. test. Both products show hydrophyllic properties which is indicative of their base materials.
- f. Film thickness - testing bond strength at a defined thickness.
- Radiopacity verifying how clear the product shows up during an Xray. g.
- Soluability- testing whether the product degrades in solutions or saliva. Look for a pass in this ﻏ section.
- Working time The amount of time you have to work with the product before it starts to set-up i.
- Compressive Strength Measures the material's ability to not break apart under a compressive j. load. Prefer a higher number.
- Compressive Modulus This shows the amount of "give" when under force. We prefer a k. similar number to our predicate.
- Metal Shear -This test checks the ability of the product to adhere to metals. We prefer a 1. number similar to our predicate.
- m. Dimension Change Determines how much water is absorbed into the product. Two sets of measurements were recorded to validate our numbers.
- Fluoride release Tested fluoride release over 28 days and Fluoride burst on the first day. n.
- o. Fluoride Burst -First day of measurements
Clinical Summary
A complete Clinical Summary of Opal® Band™ Cement is included in Section 20. We conducted a literature study to show safety and effectiveness of Opal® Band™ Cement. The product including different sizes and shapes can be used on any age patient when treatment is prescribed by a dentist or orthodontist. The device has the same technological characteristics compared to K950514 GC/3M Tri-Cure Glass lonomer Orthodontic Band Cement also known as " Unitek™Multi-Cure Glass Ionomer Band Cement"
These materials have been widely used by numerous manufacturers in the dental industry.
The efficacy or suitability to the intended purpose of Opal® Band™ Cement has been demonstrated by a combination of in-house testing and side-by-side comparisons to predicate devices currently on the market. Results of our bench testing indicates that Opal® Band™ Cement performs as well or better than the predicate device currently on the market.
6
3
Summary Risk/Benefit Review
Considering the safe history of our predicate, K950514 GC/3M Tri-Cure Glass Ionomer Orthodontic Band Cement also known as" Unitek™Multi-Cure Glass lonomer Band Cement", Opal® Band™ Cement is substantially equivalent and considered to be a safe medical device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of the predicate product.
Opal® Band™ Cement was tested for biocompatibility in Cytotoxicity, Sensitization, Irritation and Genotoxicity tests according to ISO 10993-1:2009. An abstract of the testing along with signed test reports are included in Section 15 "Biocompatibility" of this submission.
In conclusion, Opal® Band™ Cement has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and evaluated to determine safety and efficacy of similar products used for the same indication. Following the clinical review as documented above, Opal Orthodontics by Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition or the safety of the patient and the association with its use constitutes acceptable risks when weighed against the benefits to the patient. Therefore, the product is compatible with a high level of protection of health and safety and may be released to the market.
7
4
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Diane Rogers Regulatory Affairs Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
- 7 2011
Re: KI11696
Trade/Device Name: Opal® Band™ Cement Regulation Number: 21 CFR 872.3750 Regulation Name: Orthodontic Bracket Adhesive and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: June 13. 2011 Received: June 17, 2011
Dear Ms. Rogers:
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. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Rich for
Anthony D. Watson, B.S., M.S.. M.B.A. Director
Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
510(k) Number (if known):
Opal® Band™ Cement Device Name: __
Indications for Use:
Opal® Band™ Cement uses chemical, light polymerization and glass ionomer to cement all types of orthodontic bands to the teeth.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1_of 1
Susan Quanor
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 1011696
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(Posted November 13, 2003)
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