(58 days)
Not Found
No
The summary describes a mechanical orthodontic bracket and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as applying pressure to teeth via an orthodontic wire to alter tooth position, which is a therapeutic action for orthodontic movement.
No
Explanation: The device description states its purpose is to apply pressure to teeth for orthodontic movement, which is a therapeutic action, not a diagnostic one. It helps alter tooth position, rather than identify a disease or condition.
No
The device description clearly states it is a physical bracket bonded to teeth, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The CDB Flip-Slide-Clip Bracket is a physical device bonded to teeth to apply mechanical force for orthodontic movement. It directly interacts with the teeth and does not analyze biological specimens.
- Intended Use: The intended use clearly states "orthodontic movement of natural teeth," which is a mechanical process, not a diagnostic one based on analyzing biological samples.
Therefore, based on the provided information, the CDB Flip-Slide-Clip Bracket falls under the category of a dental device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation
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): 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
Ko9no2
510(k) Summary
Submitter:
AUG 0 7 2009 CDB Corporation 9201 Industrial Blvd. Leland, NC 28451 USA Phone: 910-383-6464 Fax: 910-383-6465 Contact: Charles Vernon Title: Quality/Regulatory Affairs Manager Email: cvernon@cdbcorp.net
Date Prepared:
May 20, 2009
Regulatory class II Product code: NJM
CDB Flip-Slide-Clip Bracket
Classification Panel: Dental Regulation Number: 872.5470
Bracket, Ceramic, Orthodontic
Name of Device:
Classification Name:
Device Classification:
Predicate Devices(s):
CDB Corporation Dentsply Int.
CDB Corporation
Company
Product CDB Clip Reflection Ceramic Dental Bracket In-Ovation C
Device Description:
Indications:
CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
Technical Characteristics:
The function and performance of the CDB Flip-Slide-Clip Bracket is similar to the predicate. Minor design changes and incorporation of self-ligation are the only modifications made to the Orthodontic Ceramic Brackets (Reflection®) (K922499).
CDB Corporation 510(k) Submission
Page 12 of 30
510(k)
1
There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in legally marketed CDB Corporation's devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets (In-Ovation C®) (K060837).
Conclusion:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device.
There are no major differences between the CDB Flip-Slide-Clip Bracket and the predicate device(s) cited, therefore the CDB Flip-Slide-Clip Bracket does not raise any questions regarding the safety and effectiveness.
The CDB Flip-Slide-Clip Bracket, as designed, is as safe and effective as the predicate device(s) and the device is determined to be substantially equivalent to the referenced predicate device(s) currently on the market.
CDB Corporation 510(k) Submission
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 0 7 2009
Mr. Charles Vernon Quality/Regulatory Affairs Manager CDB Corporation 9201 Industrial Boulevard Leland, North Carolina 28451
Re: K091702
Trade/Device Name: CDB Flip-Slide-Clip Self Ligating Bracket Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: May 28, 2009 Received: June 10, 2009
Dear Mr. Vernon:
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.
3
Page 2- Mr. Vernon
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/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
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
4
Indications for Use
510(k) Number (if known): KD91702
Device Name: CDB Flip-Slide-Clip Self Ligating Bracket
Indications for Use:
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use ਡ (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ve. Wiley for KSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
.
Page 11 of 30
CDB Corporation 510(k) Submission