(15 days)
No
The summary describes a system of pre-cemented orthodontic brackets and adhesives, which are physical components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The description focuses on the materials and components of the system and its similarity to predicate devices.
No
The device is described as an orthodontic bracket system used for bonding orthodontic appliances for orthodontic treatment, which is a structural rather than a therapeutic function.
No.
Explanation: The device is described as an orthodontic bracket system used for bonding orthodontic appliances for treatment, not for diagnosing a condition or disease.
No
The device description explicitly states it is comprised of physical components: pre-cemented ceramic and metal orthodontic brackets, a transfer tray, and adhesives. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in bonding orthodontic appliances for orthodontic treatment." This describes a device used directly on a patient for a therapeutic purpose (orthodontic treatment), not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details components like brackets, a transfer tray, and adhesives, all of which are used in the physical process of attaching orthodontic appliances to teeth. This aligns with a medical device used for treatment, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), generating diagnostic information, or being used in a laboratory setting.
Therefore, the Pre-Cemented Orthodontic Bracket System Extension is a medical device used for orthodontic treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pre-Cemented Orthodontic Bracket System Extension is intended for use in bonding orthodontic appliances for orthodontic treatment.
Product codes
DYH, NJM, EJF
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
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
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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