(17 days)
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.
The provided text is a 510(k) summary for the "Pre-Cemented Orthodontic Bracket System Extension II". It describes the device, its intended use, and its substantial equivalence to previously cleared devices.
Based on the information provided, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The submission asserts that the device is safe and effective based on: - Prior use of components in legally marketed devices. - Performance data provided (though specific metrics are not detailed in this summary). - Previous biocompatibility data. - The claim that shear bond strength testing, Failure Mode Effect Analysis (FMEA), and biocompatibility testing were not necessary due to no change in the super mesh base from predicate devices. |
| Substantial Equivalence | The device is deemed substantially equivalent to the predicate devices: - DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System (K061252) - DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System Extension (K081291) |
| Technological Characteristics | The device represents an addition to K081291, and all its components have been used in legally marketed devices or found safe for dental use. No change in the super mesh base for metal and ceramic brackets. |
Study Information
-
Sample size used for the test set and the data provenance:
The provided 510(k) summary does not detail any specific clinical or performance study with a test set. It relies on the substantial equivalence to predicate devices and the prior use of components. It states that "performance data provided" but does not specify what this data entails or for which tests it was collected. Therefore, information regarding sample size, country of origin, or whether it was retrospective/prospective is not available. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No specific "test set" requiring ground truth established by experts is described in this summary. The submission is based on substantial equivalence and component history rather than a new performance study requiring expert adjudication of a test set. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As no specific "test set" is detailed, no adjudication method is mentioned. -
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:
Not applicable. This device is a physical orthodontic bracket system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly detailed. The "ground truth" for the device's safety and effectiveness appears to be derived from the established safety and performance of its predicate devices and the historical use of its components. There is no mention of specific new ground truth generation through e.g., pathology or new outcomes data specific to this device extension. The statement "performance data provided" is vague. -
The sample size for the training set:
Not applicable. As this is a physical device and not an AI/machine learning algorithm, there is no concept of a "training set." -
How the ground truth for the training set was established:
Not applicable. As there is no training set mentioned, this question is not relevant.
In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to previously cleared devices. It does not present new, extensive clinical study data or a detailed performance study with a separate test set, training set, or expert adjudication as would be seen for a novel diagnostic device or AI algorithm.
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OCT 3 0 2009
Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, and the overall effect is one of solidity and strength.
510(k) SUMMARY for
Pre-Cemented Orthodontic Bracket system Extension II
06. Submitter Information:
DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
Date Prepared: 7 October 2009
2. Device Name:
- Pre-Cemented Orthodontic Bracket System Proprietary Name: .
- Extension II Adhesive, bracket and tooth conditioner, . Classification Name:
- resin CFR Number: 872.3750 .
- Device Class: II .
- DYH Product Code: .
- Sponsor's Predicate Device: నా
| Company | Device | 510(k) Number | Date Cleared |
|---|---|---|---|
| DENTSPLY International, Inc. | Pre-Cemented OrthodonticBracket System | K061252 | 02/12/2007 |
| DENTSPLY International, Inc. | Pre-Cemented OrthodonticBracket System Extension | K081291 | 05/22/2008 |
-
Description of Device: 4.
The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives. -
- Indications for Use:
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
- Indications for Use:
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
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Description of Safety and Substantial Equivalence: 6.
Technological Characteristics.
The Pre-Cemented Orthodontic Bracket System Extension II represents an addition of K081291.
All of the components found in the Pre-Cemented Orthodontic Bracket System Extension II have been used in legally marketed devices and/or were found safe for dental use. Since there is no change in the super mesh base for both the metal and ceramic brackets, shear bond strength testing, Failure Mode Effect Analysis (FMEA) and biocompatibility testing was not necessary.
We believe that the prior use of the component of the Pre-Cemented Orthodontic Bracket System Extension II in legally marketed devices, the performance data provided, and the previous biocompatibility data provided support the safety and effectiveness of Pre-Cemented Orthodontic Bracket System Extension II for the indicated uses.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 3 0 2009
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K093221
Trade/Device Name: Pre-Cemented Orthodontic Bracket System Extension II Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH, NJM, and EJF Dated: October 7, 2009 Received: October 13, 2009
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 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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Pre-Cemented Orthodontic Bracket System Extension II
Indications for Use:
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kain Moley fn MSP
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
. 510(k) Number: K093221
§ 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.