(71 days)
Not Found
No
The summary describes a physical accessory for dental aligners and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is an accessory to assist in minor tooth movement, but it does not directly treat or cure a disease or condition. It is bonded to aligners for attaching other appliances, indicating it supports a therapeutic process rather than being a therapeutic device itself.
No
The device is an accessory to dental/orthodontic aligners for tooth movement, not for diagnosing a condition or disease.
No
The device description explicitly states it is made of plastic and is bonded to an aligner, indicating it is a physical hardware component, not software.
Based on the provided information, the COMPOSITE ALIGNER BUTTON is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the COMPOSITE ALIGNER BUTTON clearly states its purpose is to be an accessory attached to dental or orthodontic aligners to assist in minor tooth movement. It is a physical component used in a mechanical process within the mouth.
- There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
The device is an accessory for a dental/orthodontic appliance, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
Product codes
NXC
Device Description
The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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
3
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
0000009