(199 days)
Not Found
No
The summary describes a passive mechanical device with no mention of AI or ML capabilities.
No
The device, an orthodontic ligating clip, assists in the orthodontic movement of teeth by holding the archwire, which is a supportive rather than a therapeutic function. Therapeutic devices are typically defined by their ability to provide treatment or therapy directly to a disease or condition for alleviation or cure, which this device does not.
No
The device, an orthodontic ligating clip, is described as an accessory that holds an archwire in an orthodontic bracket to facilitate tooth movement. Its function is mechanical and therapeutic, not diagnostic.
No
The device description clearly states it is a physical clip made of Celcon MT 24U01 Acetal (POM), which is a material used for hardware components.
Based on the provided information, the CDB Clip is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as an orthodontic bracket accessory used to hold an archwire for the orthodontic movement of teeth. This is a mechanical function within the mouth, not a diagnostic test performed on biological samples outside the body.
- Device Description: The description details a passive ligation clip made of a specific material. This aligns with a physical medical device, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The information provided strongly indicates that the CDB Clip is a Class II medical device used in orthodontics, as further supported by the predicate device listed (K042905 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY), which is also an orthodontic bracket accessory.
N/A
Intended Use / Indications for Use
The CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The CDB Clip is a passive ligation clip which functions to retain the orthodontic archwire in the slot of an orthodontic bracket. It is made of Celcon MT 24U01 Acetal (POM) with no fillers.
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
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
510(K) SUMMARY
OCT 1 7 2008
| Submitter: | CDB Corporation
9201 Industrial Blvd.
Leland, NC 28451 USA
Phone: 910 383-6464
Fax: 910 383-6465
Contact: Jens Rumsfeld
Title: Mgr. Managing Director
e-mail: jrumsfeld@cdbcorp.net | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Date Prepared: | January 22, 2008 | |
| Name of device: | The CDB Clip - Orthodontic Bracket Accessory | |
| Classification Name | Bracket, Ceramic, Orthodontic | |
| Device Classification | Regulatory Class II
Product Code: NJM
Classification Panel: Dental
Regulation Number: 21 CFR 872.5470 | |
| Predicate Device(s) | | |
| 510(k) Number | Device | Manufacturer |
| K042905 | NEO-CLIP ORTHODONTIC
BRACKET ACCESSORY | Dentsply International |
| Device Description | The CDB Clip is a passive ligation clip which functions to retain the
orthodontic archwire in the slot of an orthodontic bracket. It is made of
Celcon MT 24U01 Acetal (POM) with no fillers. | |
| Indications | The CDB Clip, commonly known as an orthodontic ligation clip, is an
orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the
archwire firmly in the slot. Together they facilitate the orthodontic movement of
teeth. | |
| Technological Characteristics | The function and performance of the CDB Clip is identical to the predicate
device listed above. There is no difference in the fundamental technology.
The CDB Clip is made of the same material as the predicate device currently
on the market and has the same overall intended use. | |
1
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 Clip and the predicate device cited, therefore, the CDB Clip does not raise any questions regarding the safety and effectiveness.
The CDB Clip, as designed, is as safe and effective as the predicate device and the device is determined to be substantially equivalent to the referenced predicate device currently on the market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2008
Mr. Jens Rumsfeld Managing Director CDB Corporation 9201 Industrial Boulevard Leland, North Carolina 28451
Re: K080906
Trade/Device Name: CDB Clip Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: September 12, 2008 Received: September 16, 2008
Dear Mr. Rumsfeld:
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.
3
Page 2 – Mr. Rumsfeld
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Th. Spraguelsted, m.D. for "
Chiu S. Lin, Ph. D Division 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): K080906
Device Name: CDB Clip
Indications For Use:
The CDB Clip, commonly known as an orthodontic ligating clip, is an orthodontic bracket accessory. It attaches to the orthodontic bracket to hold the archwire firmly in the slot. Together they facilitate the orthodontic movement of teeth.
Susan Punaes
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080996
Prescription Use X (Part 21 CFR 80'1 Subpart D) ANDIOR
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 (OD E)