(71 days)
The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.
The provided documentation is a 510(k) summary for the DENTSPLY COMPOSITE ALIGNER BUTTON. This submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a study demonstrating performance against specific acceptance criteria in the manner often seen for more complex diagnostic or image analysis AI/ML devices.
Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert roles, MRMC studies) is not applicable or not present in this type of regulatory submission for this specific device.
Here's an breakdown based on the information available and what is not applicable:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable / Not Provided. This 510(k) relies on demonstrating that the Composite Aligner Button has similar technological characteristics (made of plastic, components used in legally marketed devices, biocompatibility) and the same intended use as legally marketed predicate devices. The "performance" in this context is the general safety and effectiveness implied by its composition and intended use, which is established through comparison to predicates rather than a specific performance metric against a defined acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. No "test set" in the context of performance metrics (like sensitivity, specificity, accuracy) is mentioned or required for this type of device submission. The submission is based on the characteristics of the device itself and its components, not on its performance in a clinical study with a test set of data.
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 / Not Provided. No ground truth establishment for a test set is discussed, as there was no performance study of this nature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No test set or adjudication method is mentioned.
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:
- Not Applicable / Not Provided. This device is an accessory for orthodontic aligners, not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This device is a physical accessory and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided. No ground truth is referenced as no performance study requiring a ground truth was conducted.
8. The sample size for the training set:
- Not Applicable / Not Provided. No training set for an AI/ML algorithm is involved with this physical accessory.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided. As no training set is discussed, there's no ground truth establishment for it.
Summary of available relevant information from the 510(k) submission:
- Device Name: COMPOSITE ALIGNER BUTTON
- Intended Use: An accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
- Technological Characteristics claimed to ensure safety and effectiveness:
- Made of plastic.
- Components have been "used in legally marketed devices and/or were found safe for dental use."
- Appropriate biocompatibility testing has been completed.
- Predicate Devices:
- Basis for Acceptance: The device was found substantially equivalent to the predicate devices based on its intended use and technological characteristics, particularly the prior safe use of its components and biocompatibility data. This type of submission does not involve a clinical study with performance metrics against acceptance criteria, but rather a regulatory review of equivalence.
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510(k) SUMMARY
APR 1 1 2008
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
CONTACT:
Helen Lewis
DATE PREPARED:
January 28, 2008
TRADE OR PROPRIETARY NAME: COMPOSITE ALIGNER BUTTON
CLASSIFICATION NAME:
Sequential Aligner NXC 872.5470
PREDICATE DEVICES:
Align System K981095 Thermoform Sheet Materials and Accessories K072522
The COMPOSITE ALIGNER BUTTON is made of plastic and is DEVICE DESCRIPTION: bonded to an aligner for attaching elastics and other appliances.
The COMPOSITE ALIGNER BUTTON is an accessory that is INTENDED USE: attached to dental or orthodontic aligners to assist in minor tooth movement.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in the COMPOSITE ALIGNER BUTTON have been used in legally marketed devices and/or were found safe for dental use. Appropriate biocompatibility testing has been completed.
We believe that the prior use of the components of the COMPOSITE ALIGNER BUTTON in legally marketed devices and the biocompatibility data provided support the safety and effectiveness of the COMPOSITE ALIGNER BUTTON for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The image is in black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 11 2008
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K080246
Trade/Device Name: Composite Aligner Button Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: April 7, 2008 Received: April 9, 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" (21CFR 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.
Sincerely yours,
Cmu 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 STATEMENT
510(k) Number (if known):
Device Name:
COMPOSITE ALIGNER BUTTON
Indications for Use:
The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental orthodontic aligners to assist in minor tooth movement.
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)
Robert Betz DDS for Dr. Susan Runner
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080246
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§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.