(85 days)
Not Found
No
The device description and the absence of mentions of AI, ML, or related concepts strongly suggest this is a traditional mechanical orthodontic bracket.
Yes
The device is indicated for "orthodontic movement of natural teeth," which is a therapeutic purpose to correct dental alignment.
No
Explanation: The device description clearly states its intended use is for "orthodontic movement of natural teeth," and it is an "Orthodontic Ceramic bracket." There is no mention of it being used to diagnose a condition, disease, or injury.
No
The device description clearly states it is a physical ceramic bracket made of alumina single crystal, consisting of three parts intended to be placed on teeth. This is a hardware device, 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 "orthodontic movement of natural teeth". This is a mechanical action performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an "Orthodontic Ceramic bracket" designed to be placed on teeth to straighten them. This is a physical device used for treatment, not for diagnostic testing.
- Lack of IVD Characteristics: The description 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly an orthodontic appliance used for therapeutic purposes (straightening teeth), which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring. And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth, excluding mandibular bicuspid 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)
Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent.
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
MAY 2 7 2009
" : ".
。
510(K) SUMMARY
[as required by 807':92(c)]
-
- Identification of the Device:
-Proprietary-Trade Name: "Orthodontic Ceramic Bracket (ABSOLUTE)" Star Dentech Korea., Corp.
- Identification of the Device:
-Classification Name: bracket, ceramic, orthodontic, Product Code: NJM -Common/Usual Name: Orthodontic Ceramic Bracket / Orthodontic Ceramic Bracket
-
- Equivalent legally marketed device:
This product is similar in design and identical in function to the K073045 / SAPPHIRE CERAMIC BRACKET / ORTHO TECHNOLOGY, INC
- Equivalent legally marketed device:
-
- Indications for Use (intended use):
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth
- Indications for Use (intended use):
-
- Description of the device:
Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring.
- Description of the device:
And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.
-
- Testing information and Conclusion
In all material respects, the "Orthodontic Ceramic bracket (ABSOLUTE)" is
- Testing information and Conclusion
1
substantially equivalent to SAPPHIRE CERAMIC BRACKET (K073045) ORTHO TECHNOLOGY, INC. Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent.
.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Star Dentech Korea. Corporation C/O Mr. Brandon Choi General Manager Pats Corporation 49 Candlewood Way Buena Park, California 90621
Re: K090567
Trade/Device Name: Orthodontic Ceramic Bracket Regulation Number: 21 CFR 872,5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: February 14, 2009 Received: March 3, 2009
Dear Mr. Choi:
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. Choi
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 Runner
Susan Runner, D.D.S., MA 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):
Device Name: Orthodontic Ceramic Bracket
Indications for use: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth
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 NEEDED)
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Huly for MSP
Page 1 of 1 .
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090567