(64 days)
Not Found
No
The summary describes a physical orthodontic bracket and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to apply forces to teeth to alter their position as part of orthodontic treatment, which is a therapeutic intervention.
No
The device is described as an orthodontic bracket used to apply forces to teeth for movement, which is a treatment modality, not a diagnostic one.
No
The device description clearly states it is a physical ceramic bracket bonded to teeth, which is a hardware component, not software.
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 teeth." This is a mechanical action performed directly on the patient's body (teeth).
- Device Description: The device is a physical bracket bonded to teeth to apply force. It's a physical appliance used for treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used in vitro (outside the body) to examine specimens from the human body for diagnostic purposes. This device is used in vivo (within the body) for therapeutic purposes (orthodontic treatment).
N/A
Intended Use / Indications for Use
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The Orthodontic Ceramic Brackets are bonded to tecth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. The function and performance of the orthodontic ceramic brackets are equal to the predicate device. The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
133
JUN - 5 2009
Page 12
510(k) Summary of Safety & Effectiveness
in accordance with requirements 21 CFR 807.92.
1. Company
Bernhard Forster GmbH Westliche Karl- Friedrichstraße 151 75172 Pforzheim - Germany
| Telephone: | 049-7231-459-0 |
|---|---|
| Fax: | 049-7231-459-102 |
| Contact: | Michael Fieß |
2. Device
Orthodontic Ceramic Brackets Proprietary - trade name : Bracket, Ceramic, Orthodontic, product code NJM Classification name:
3. Equivalent legally marketed devices:
Orthodontic Ceramic Bracket Innovation C (K060837), Dentsply International
4. Indication for use:
The device is intended for orthodontic movement of theth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
5. Description of the device
The Orthodontic Ceramic Brackets are bonded to tecth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation
The function and performance of the orthodontic ceramic brackets are equal to the predicate device.
The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.
| Device name | In- Ovation C
Dentsply | Bernhard Forster GmbH
Orthodontic Ceramic brackets |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
classification
name | Orthodontic Ceramic Bracket
CFR 872.5470, NJM | Orthodontic Ceramic bracket CFR 872.5470; NJM |
| Applicant | Dentsply International | Bernhard Forster GmbH |
| 510(k) - Number | (K060837) | This submission |
| Material | A1203 | ALSO3 |
| Intended use | The innovation C is intended
for orthodontic movement of
natural teeth , excluding the
mandibular bicuspid teeth . | The device is intended for orthodontic movement of teeth.
It is used temporarily and is removed after orthodontic
treatment has been completed. The devices are intended to
be single used only. |
| Single use? | YES | YES |
| Sterility | Non-sterile | Non-sterile |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.
Public Health Service
JUN - 5 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Fieb Regulatory Affairs Manager Forestadent Bernhard Förster GmbH Westliche Karl- Friedrich-Straße 151 75172 Pforzheim GERMANY
Re: K090933
Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 21.CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: March 31, 2009 Received: April 2, 2009
Dear Mr. Fieb:
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.
2
Page 2- Mr. Fieb
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 yours,
Susan Penney
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
Enclosure
3
4. Indications for Use
510(k) Number (if known):
Device Name: Orthodontic Ceramic Brackets
Indications For Use: The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lei Mulvey for MSR
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090933