(85 days)
Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.
Opal® Bond MV is a light cure orthodontic adhesive.
The provided document is a 510(k) summary for a medical device (Opal® Bond MV, an orthodontic adhesive). It outlines the device's intended use and claims substantial equivalence to predicate devices based on various tests. However, it does not contain a table of acceptance criteria or specific performance metrics from a study that "proves the device meets the acceptance criteria" in the way one would expect for a more complex AI/software medical device.
The information provided describes the types of tests performed and states that a "detailed Clinical Summary" with supporting literature was included in the submission, but the details of this summary and specific performance results are not present in the excerpt.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the excerpt. The document lists several tests performed (Shear Peel, Flexural Strength, Hardness, Shear Bond with bracket, Compressive, Metal Shear, Depth of Cure, Tensile Pull, Ambient Light Sensitivity, Clinic, Lab) and states that these were "compared to 3M Unitek's Transbond (K073697)". However, it does not detail:
- Specific acceptance criteria (e.g., "Shear Bond strength must be greater than X MPa").
- The actual quantitative results of Opal® Bond MV for these tests.
- The quantitative results of 3M Unitek's Transbond for comparison.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text. It mentions "Clinical Summary" and "literature," implying some human data might be involved, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable or Not specified. This device is an adhesive, and its performance would typically be measured through objective mechanical and chemical tests rather than expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would. If a "Clinic" test involved human assessment, the details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable or Not specified. This is a mechanical/chemical properties study, not a human reader study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the technical tests (Shear Peel, Flexural Strength, etc.), the "ground truth" would be established by standardized laboratory testing procedures and universally accepted scientific definitions of these material properties, measured using instruments.
- For the "Clinic" test, if it involved a clinical trial, the "ground truth" would likely be based on clinical outcomes relevant to orthodontic bonding (e.g., bracket retention, adverse events) assessed by clinical experts, but this is not detailed.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance is based on its material properties, developed through R&D (which might involve iterative testing, but not "training data" in the AI sense).
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/machine learning device.
In summary:
The provided document details a Traditional 510(k) submission for an orthodontic adhesive. The "study" referenced involves a series of mechanical and chemical tests comparing the new device (Opal® Bond MV) to an existing predicate device (3M Unitek's Transbond). However, the specific quantitative results of these tests and the defined acceptance criteria are not included in this excerpt. The document implicitly claims that the device meets acceptance criteria by stating "substantial equivalence" based on these tests and supporting literature, but the raw data or detailed performance tables are omitted from this summary.
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Section 5
MAR 2 3 2010
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: | Diane Rogers |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | 800-552-5512 x4491, 801-553-4491 |
| FAX: | 801-553-4609 |
| Date Summary Prepared: | December 23, 2009 |
Name of the Device
| Trade Name: | Opal® Bond MV |
|---|---|
| Common Name: | Bracket Adhesive Resin and Tooth Conditioner |
| Device Classification: | II |
| Classification Product Code: | DYH |
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is: Opal Bond (K071055). This device is manufactured and distributed by Opal Orthodontics by Ultradent Products, Inc., 505 West, 10200 South, South Jordan,Utah 84095. The Indications for Use have been changed.
Opal® Bond MV is also very similar to one of our competitor's products namely: 3M Unitek Transbond (K073609) Both products are used to adhere brackets and bondable appliances to etched enamel.
Substantial equivalence: Opal® Bond MV formula is similar to Ultradent's Opal Bond (K071055) formula.
Opal® Bond MV is also very similar to one of our competitor's products namely: 3M Unitek's Transbond (K073697).
Opal Orthodontics
Traditional 510(k) Submission for Opal® Bond™ Flow
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A comparison of the three products to determine substantial equivalence:
| Product | 510(k) number | Classification name | Indications for Use |
|---|---|---|---|
| Opal Bond MV | New | Adhesive, Bracket and Tooth Conditioner | Light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel. |
| Opal Bond | K071055 | Adhesive, Bracket and Tooth Conditioner | ...This system is a bondable device for fixed attached orthodontics |
| Transbond | K073698 | Adhesive, Bracket and Tooth Conditioner | Transbond XT Light Cure Orthodontic Adhesive is designed for bonding ceramic and metal orthodontic brackets |
Indications for Use
Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.
Brief Description of Testing Performed
The following tests were conducted during the R & D phase on Opal® Bond MV and compared to 3M Unitek's Transbond (K073697).
- a. Shear Peel
- b. Flexural Strength
- c. Hardness
- d. Shear Bond with bracket
- e. Compressives
- f. Metal Shear
- g. Depth of Cure
- h. Tensile Pull (Ibf)
- i. Ambient Light Sensitivity
- j. Clinic
- k. Lab
Clinical Summary
A detailed Clinical Summary is included in this submission. It contains literature which we have selected that supports our claims for the safety and efficacy of Opal® Bond MV.
Opal Orthodontics
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ultradent Products, Incorporated C/O Ms. Diane Rogers Regulatory Affairs Manager Opal Orthodontics 505 West 10200 South South Jordan, Utah 84095
MAR 2 3 2010
Re: K094006
Trade/Device Name: Opal® Bond MV Regulation Number: 21CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: December 24, 2010 Received: December 28, 2010
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: CDRH 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.
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Page 2- Ms. Rogers
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 (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,
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,
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
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Statement of Indications for Use
510(k) Number (if known): K094006
Opal® Bond MV Device Name:
Indications for Use:
Opal® Bond MV is a light cure orthodontic adhesive designed for bonding brackets and other bondable appliances to etched enamel.
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)
KSBetz DDS for Dr. K.P. Mulbry
(Division Sign-Off)
Division of Anesthesiology, General F Infection Control, Dental Devic
510(k) Number: K094006 Page_
Page 1 of 1
(Posted November 13, 2003)
§ 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.