(274 days)
Not Found
No
The description focuses on the material and mechanical function of orthodontic brackets and does not mention any AI/ML components or capabilities.
Yes
The device is intended for the "orthodontic movement of teeth" and applies "pressure to the tooth...to alter the tooth position," which describes a therapeutic action.
No
The device description clearly states its purpose is for "orthodontic movement of teeth" by applying pressure to alter tooth position, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a ceramic bracket made of Al203, which is a physical hardware component. The summary also describes bonding the brackets to teeth and linking them with an "arch wire," further indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "for the orthodontic movement of 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 description details how the brackets are bonded to teeth and apply pressure to move them. This is a physical intervention, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- Biocompatibility Testing: The performance studies focus on biocompatibility and mechanical properties (maxillary torque), which are relevant for devices that interact with the body, not for IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Product codes
NJM
Device Description
The brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum ox-ide(99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady. gentle pressure to produce desired tooth movement.
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
In addition to testing to determine maxillary torque, the orthodontic bracket was found to be in compliance with biocompatibility, biocompatibility study has been applied to the new device in accordance with the following standard
ISO 10993 Biological evaluation of medical devices
Part 1 - Evaluation and testing in the risk management process
Part 5 - Tests for in vitro cytotoxicity
Part 10 - Tests for irritation and delayed-type hypersensitivity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2015
Speed Dental Co., Ltd. c/o Ho Dong Yang CEO Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu. Seoul 135-768 KOREA
Re: K150141
Trade/Device Name: Orthodontics Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: July 21, 2015 Received: July 27, 2015
Dear Ho Dong Yang:
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.
1
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 devicerelated 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 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Tina
Kiang -S
for Erin I. Keith, M.S. 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
510(k) Number (if known) K150141
Device Name Trade name: Orthodontics Bracket
Indications for Use (Describe)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
| Submitter Information: | Speed Dental Co., Ltd.
#203-1, A-dong, Posco the Sharp, 151 Sunhwa-dong
Jung-gu, Seoul, 100-130, Korea
Tel: +82-2-777-2809 Fax: +82-2-777-2803 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 837-26 Yeuksam-dong
Gangnam-gu, Seoul, 135,768, Korea
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com |
| Date Summary Prepared: | OCT 21, 2015 |
Device Information:
Trade Name(s): Classification Name: Panel: Product code:
Orthodonics Bracket bracket, orthodontic, ceramic dental NJM
Predicate Device Information:
K073045 / Sapphire Ceramic Bracket
Device Description:
The brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum ox-ide(99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady. gentle pressure to produce desired tooth movement.
Indications for Use:
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- indications for use
-
- technological characteristics
-
- performance properties
Summary of the technological characteristics compared to the predicate device
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new device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below
| Orthodontics Bracket | Sapphire Ceramic Bracket | |
|---|---|---|
| Manufacturer | Speed Dental Co., Ltd. | Ortho Technology Inc |
| 510(k) Number | K150141 | K073045 |
| Indications for use | This device is intended for the | |
| orthodontic movement of | ||
| teeth. It is used temporarily | ||
| and is removed after | ||
| orthodontic treatment has | ||
| been completed. The devices | ||
| are intended to be single use | ||
| only | Sapphire Ceramic Bracket is | |
| intended for use in orthodontic | ||
| treatments. The brackets are affixed | ||
| to teeth so that pressure can be | ||
| exerted on the teeth. | ||
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable | |
| requirement of ISO 10993 | Meets the applicable requirement of | |
| ISO 10993 | ||
| Maxillary In-out(mm) | 1.04 - 1.19 | 0.53 - 0.89 |
| Maxillary | ||
| Torque(mm) | -7 to +12 | -7 to +17 |
| Maxillary Angulation | 0 - 10 | 0.51 - 10 |
| Slot | 0.022" | 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Colour | White, same as tooth colour | White, same as tooth colour |
| Indication system | Coloured-dot | dot |
| Design parts | Hook, Slot, Round home, base and marking | Hook, Slot, Round home, base and |
| marking | ||
| Intended use | This medical device is a | |
| bracket to be attached to | Sapphire Ceramic Bracket is | |
| intended for use in orthodontic | ||
| treatment. The brackets are affixed | ||
| teeth for orthodontic purpose | ||
| and it is made of ceramic | ||
| material. | to teeth so that pressure can be | |
| exerted on the teeth. |
Comparison table is as follows
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Differences between the proposed and predicate devices are not expected to affect the overall performance of the device. These differences include slight variations in design such as maxillary angulation and torque. While the ranges are not identical, they are still within the range of what is typically observed for orthodontic brackets.
Non-Clinical Study performance
In addition to testing to determine maxillary torque, the orthodontic bracket was found to be in compliance with biocompatibility, biocompatibility study has been applied to the new device in accordance with the following standard
ISO 10993 Biological evaluation of medical devices
Part 1 - Evaluation and testing in the risk management process
Part 5 - Tests for in vitro cytotoxicity
Part 10 - Tests for irritation and delayed-type hypersensitivity
Conclusion
The Orthodontics Bracket has the same device characteristics as the predicate device, Based on the information provided in this summary we conclude that Orthodontics Bracket is substantially equivalent to the predicate device K073045.