(15 days)
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).
This 510(k) submission (K081291) describes a modification to an existing device, adding a second ceramic orthodontic bracket to an already cleared Pre-Cemented Orthodontic Bracket System (K061252), which itself includes components from K060837. This submission does not contain information about a study based on acceptance criteria in the traditional sense of a clinical performance study with defined endpoints like sensitivity, specificity, or inter-reader agreement.
The device, a Pre-Cemented Orthodontic Bracket System Extension, is a dental device intended for use in bonding orthodontic appliances. The core of this submission focuses on demonstrating that the new component maintains the same safety and effectiveness characteristics as the predicate devices.
Here's an breakdown of the information available in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluated and passed biocompatibility testing for devices classified as surface-contacting devices with permanent contact. No additional testing required as there are no changes in formulation from predicate devices (K060837 and K061252). |
| Equivalence to Predicate Devices (Safety and Effectiveness) | Components of the Pre-Cemented Orthodontic Bracket System Extension have been used in legally marketed devices and/or were found safe for dental use. The prior use of components, previous biocompatibility data, and "performance date" (likely meant "performance data") support safety and effectiveness. The device maintains the same fundamental technology and intended use as the predicate device K061252. |
| Compliance with Regulatory Requirements | The device is deemed substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls provisions of the Act. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. There is no explicit "test set" in the context of a clinical performance study to evaluate diagnostic performance or similar metrics. The evaluation relies on established safety and performance data from predicate devices and component materials rather than a new clinical trial.
- Data Provenance: Not applicable. The submission refers to "previous biocompatibility data" and "performance date (data)" from the predicate devices (K060837 and K061252) and the prior use of components in legally marketed devices. This would be considered retrospective in the sense of leveraging existing data, but it's not a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There is no "test set" in the context of a clinical performance study requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool, but rather a physical orthodontic bracket system. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI algorithm.
7. The Type of Ground Truth Used
- The ground truth, in an indirect sense, is established by regulatory clearance and historical safety/effectiveness of the predicate devices and the individual components used. The biocompatibility data also serves as a ground truth for a specific safety aspect. It's not based on expert consensus for diagnostic accuracy, pathology, or outcomes data from a new study.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set for an AI algorithm is involved.
Summary of the Study (or Lack Thereof) to Prove Acceptance Criteria:
The "study" in this context is a benchmarking and equivalency assessment against predicate devices and known material safety. The manufacturer did not conduct a new clinical study to establish acceptance criteria for performance; instead, they demonstrated that:
- The device components are already used in legally marketed devices.
- The device's materials have established biocompatibility, and since the formulation hasn't changed, no new biocompatibility testing was deemed necessary.
- The device maintains the same fundamental technology and intended use as its predicate.
The FDA's review concluded that the device is "substantially equivalent" to the predicate devices, thereby meeting the necessary regulatory acceptance for marketing. This type of submission relies heavily on a comparison to existing, cleared devices rather than new performance data generation for defined acceptance criteria.
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510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis | |
|---|---|---|
| DATE PREPARED: | May 5, 2008 | MAY 22 2008 |
| TRADE OR PROPRIETARY NAME: | Pre-Cemented Orthodontic Bracket System Extension | |
| CLASSIFICATION NAME: | Bracket adhesive resin and tooth conditioner | |
| CFR NUMBER: | 872.3750 | |
| DEVICE CLASS: | II | |
| PRODUCT CODE: | DYH | |
| PREDICATE DEVICES: | Pre-Cemented Orthodontic Bracket System, K061252 In-Ovation™ C, K060837. |
DEVICE DESCRIPTION: The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).
INTENDED USE: The Pre-Cemented Orthodontic Bracket System Extension is intended for use in bonding orthodontic appliances for orthodontic treatment.
TECHNOLOGICAL CHARACTERISTICS: The Pre-Cemented Orthodontic Bracket System Extension represents a modification to K061252.
All of the components found in the Pre-Cemented Orthodontic Bracket System Extension have been used in legally marketed devices and/or were found safe for dental use. The Pre-Cemented Orthodontic Bracket System Extension has been evaluated and passed biocompatibility testing for devices classified as surface-contacting devices with permanent contact. As there are no changes in formulation from the predicate devices (K060837 and K061252), we believe that no additional biocompatibility testing is required.
We believe that the prior use of the components of Pre-Cemented Orthodontic Bracket System Extension in legally marketed devices, the previous biocompatibility data, and the performance date provided support the safety and effectiveness of the Pre-Cemented Orthodontic Bracket Systension for the indicated uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2008
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K081291
Trade/Device Name: Pre-Cemented Orthodontic Bracket System Extension Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH, NJM, EJF Dated: May 5, 2008 Received: May 7, 2008
Dear Ms. Lewis:
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.
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Page 2- Ms. Lewis
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Sayite Y. Michaud md.
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known): K081291
Device Name: Pre-Cemented Orthodontic Bracket System Extension
Indications for Use:
The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sven Puma
(Division Sign-Off) Division of Anesthesinlogy, General Hospital Infection Control, Dental Devices
1 -101 510(k) Number:
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§ 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.