(19 days)
Not Found
No
The description focuses on the physical characteristics and function of ceramic orthodontic brackets, with no mention of AI or ML.
Yes.
The device's intended use is to alter tooth position through applied pressure, which is a therapeutic intervention for orthodontic movement of natural teeth.
No
Explanation: The device, ORTHODONTIC CERAMIC BRACKETS, is described as being used to apply pressure to teeth to alter tooth position for orthodontic movement. It is a therapeutic device, not one that identifies or analyzes a disease or condition.
No
The device description clearly describes physical ceramic brackets that are bonded to teeth, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic movement of natural teeth". This is a mechanical action performed directly on the patient's teeth to alter their position.
- Device Description: The device is described as "ORTHODONTIC CERAMIC BRACKETS" that are "bonded to teeth to apply pressure". This is a physical device used for a therapeutic purpose.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Product codes
NJM
Device Description
The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth
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)
Not Found
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
§ 872.5470 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
AUG 3 0 2004
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | P. Jeffery Lehn |
|---|---|
| DATE PREPARED: | August 3, 2004 |
| TRADE OR PROPRIETARY NAME: | ORTHODONTIC CERAMIC BRACKETS |
| CLASSIFICATION NAME: | Orthodontic Bracket, 872.5470 |
| PREDICATE DEVICES: | Ceramic Orthodontic Bracket, K852179 |
DESCRIPTION OF DEVICE: The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.
INTENDED USE: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
TECHNOLOGICAL CHARACTERISTICS: The function and performance of the modified brackets is very similar to the predicate. Minor design changes and a change in transparency are the only modifications made to K852179.
There are no changes in intended use or fundamental scientific technology. All of the materials in the device have been used in legally marketed DENTSPLY devices. We believe that the modified device is substantially equivalent to K852179.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2004
Dentsply International C/O Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K042178
Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 3, 2004 Received: August 11, 2004
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Because and he 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to act rood Cosmetic Act (Act) that do not require approval of a premarket the Federal I vou, Drag, and Comments , therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include controls provisions of the ristiation, 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 If your device is classified (boo as a very additional controls. Existing major regulations affecting (1 MA), it may of subject to back and Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advisod that 12 a determination that your device complies with other requirements Incall that I DX has made a atutes and regulations administered by other Federal agencies. of the Act of ally I oderal buttonents, including, but not limited to: registration 1 ou inust comply with and 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 001), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the qt 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) I mis letter will anow you to began finding of substantial equivalence of your device to a premiarket notification. - The Pist 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), II you desire specific at 100 for your at (301) 594-4613. Also, please note the regulation prease condact the Other of reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/dsma/dsmamain.html
Sincerely yours,
Susan Runror
Chin-Lin, Ph.D.
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
3
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K042178
ORTHODONTIC CERAMIC BRACKETS Device Name:
Indications for Use:
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid tecth.
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 NEEDEL
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swae Kumar
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: