(175 days)
No
The 510(k) summary describes a mechanical orthodontic bracket and does not mention any AI/ML components or functionalities.
Yes
The device is used to apply pressure to teeth to alter their position, which is a therapeutic intervention for orthodontic movement.
No
Explanation: The device, a self-ligating bracket, is used to apply pressure to teeth for orthodontic movement. Its purpose is to alter tooth position, which is a treatment rather than a diagnosis.
No
The device description clearly states it is a physical 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 uncompromised natural teeth". This describes a physical intervention on the patient's body to alter tooth position.
- Device Description: The device is a bracket bonded to teeth to apply pressure via a wire. This is a mechanical device used directly on the patient.
- 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 outside the body to analyze biological samples. This device is used inside the mouth, directly on the teeth.
N/A
Intended Use / Indications for Use
The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
CDB Self Ligating Bracket 8F is 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 placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket.
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)
Comparative shear bond strength testing was conducted to the noted predicate device and that the results demonstrated that the bond strength was as strong as the predicate.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2016
CDB Corporation Yannire Thompson Quality & Regulatory Affairs Manager 9201 Industrial Boulevard, NE Leland. North Carolina 28451
Re: K160957
Trade/Device Name: CDB Self Ligating Bracket 8F Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: August 31, 2016 Received: September 1, 2016
Dear Yannire Thompson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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): K160957/S002
Device Name: CDB Self Ligating Bracket 8F
Indications for Use:
The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid.
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)
3
Image /page/3/Picture/0 description: The image shows the logo for Ceramic Dental Brackets. The logo consists of the letters "cdb" in a stylized font, with the top half of the letters in a lighter blue and the bottom half in a darker blue. Below the letters, the words "CERAMIC DENTAL BRACKETS" are written in a smaller, gray font.
510(k) Summary
| Submitter: | CDB Corporation
9201 Industrial Blvd, NE
Leland, NC 28451 USA
Phone: 910-383-6464
Fax: 888-280-1556
Contact: Yannire Thompson
Title: Quality/Regulatory Affairs Manager
Email: ythompson@cdbcorp.net | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|----------------|
| Date Prepared: | September 16th, 2016 | | |
| Name of Device: | CDB Self Ligating Bracket 8F | | |
| Common Name: | Self Ligating Bracket | | |
| Classification Name: | Bracket, Ceramic, Orthodontic | | |
| Device Classification: | Regulatory class II
Product code: NJM
Classification Panel: Dental
Regulation Number: 872.5470 | | |
| Primary Predicate Device: | Company Dentsply Int. | Product In-Ovation C | 510(k) K060837 |
| Device Description: | CDB Self Ligating Bracket 8F is 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 placement and removal through self-ligation and enhancing the bonding and debonding characteristic of the bracket. | | |
| Indications: | The CDB Self Ligating 8F bracket is indicated for orthodontic movement of uncompromised natural teeth, excluding mandibular bicuspid. | | |
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Image /page/4/Picture/0 description: The image shows a logo for "CDB CERAMIC DENTAL BRACKETS". The logo is in blue and consists of the letters "CDB" stacked on top of each other. The top half of the letters are a lighter blue, while the bottom half is a darker blue.
| Technical Characteristics: | The function, performance, and contact material of the CDB Self Ligating 8F is similar to the predicate. Minor design changes are the only modifications made to the In-Ovation C (K06083). |
|---|---|
| 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 devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets In-Ovation C (K060837). | |
| Performance Testing: | Comparative shear bond strength testing was conducted to the noted predicate device and that the results demonstrated that the bond strength was as strong as the predicate. |
| Physical Properties, | |
| Materials, Intended use | |
| Comparison: | The CDB Self Ligating Bracket 8F is identical in use, contact material type, manufacturing methods (injection molding, sintering, stamping, and plating), and duration of patient contact as the primary predicate device In-Ovation C (K060837). |
| FDA requested to include here a table, similar to the one provided in the biocompatibility section, which compares the physical properties, materials, and intended use of The CDB Self Ligating Bracket 8F to the designated primary predicate device. Please find below a comparison for the primary predicate and the CDB Self Ligating Bracket 8F: |
CDB Corporation 510(k) Submission
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Image /page/5/Picture/0 description: The image is a logo for Ceramic Dental Brackets. The logo is made up of the letters "cdb" in a stylized font. The top half of the letters are blue, and the bottom half are a darker blue. Below the letters, the words "CERAMIC DENTAL BRACKETS" are written in a smaller, gray font.
| Property | CDB Self Ligating Bracket 8F | Primary Predicate
Dentsply InOvation C | |
|------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Bracket Composition: | Aluminum Oxide | Aluminum Oxide
Silicon Dioxide | |
| Clip Material: | Nickel
Titanium | Manganese
Nickel
Chromium
Molybdenum
Niobium
Titanium
Iron
Cobalt | |
| | Clip Coating: | Gold
Rhodium | Gold
Rhodium |
| | | Intended Use: | Indicated for orthodontic movement of
uncompromised natural teeth, excluding
mandibular bicuspids. |
| | Principles of Operation: | The wire is held in a passive, interactive, or
active state by the clip. The clip slides into
and out of place to ligate the wire. | The wire is held in a passive, interactive, or
active state by the clip. The clip slides into
and out of place to ligate the wire. |
| | Aesthetic Features | Clear (translucent) bracket system | Clear (translucent) bracket system |
| | Physical properties | Mechanical retention | Mechanical retention |
| | Application | Bonded | Bonded |
| | Manufacturing Method | Injection molding | Injection molding |
| Contact Classification | Permanent surface contacting device which
contacts the mucosal membrane | Permanent surface contacting device which
contacts the mucosal membrane | |
| Color Additives | None | Unknown | |
CDB Corporation 510(k) Submission
6
Image /page/6/Picture/0 description: The image is a logo for "CERAMIC DENTAL BRACKETS". The logo consists of the letters "cdb" in a stylized font, with the top half of the letters in a lighter blue and the bottom half in a darker blue. The words "CERAMIC DENTAL BRACKETS" are written in a smaller font below the letters.
| FDA requested to provide the name of another predicate device that has the same chemical composition as CDB Self Ligating Bracket 8F clip material. Please see below for two reference devices: |
|---|
| Click-it (K111234) by TP Orthodontics. Click-it is a self ligating ceramic bracket with a Nickel titanium clip. |
| Clarity SL (K062345) by 3M Unitek. Clarity SL is a self ligating ceramic bracket with a Nickel titanium clip. |
| Conclusion: |
| By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate devices. |
| There are no major differences between the CDB Self Ligating Bracket 8F and the predicate device cited; therefore the CDB Self Ligating Bracket 8F, as designed, is determined to be substantially equivalent to the referenced primary predicate device and reference devices currently on the market. |
CDB Corporation 510(k) Submission
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