(26 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a physical orthodontic bracket, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for "orthodontic movement," which is a therapeutic intervention to correct tooth position.
No
Explanation: The device, an orthodontic bracket, is used for mechanical tooth movement and does not gather or interpret data about a patient's health condition to make a diagnosis.
No
The device description clearly states it is comprised of single crystal alumina and has physical components (arch wire slot, tie wings, base) that are adhered to a patient's tooth. This indicates a physical medical device, not a software-only one.
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 natural teeth." This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details a physical bracket designed to be attached to teeth to apply force for movement. This is a mechanical device used for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly a medical device used for orthodontic treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Translucent Orthodontic Bracket is 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
The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
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)
Bench tests and functional testing studies, according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure were conducted. The risk analysis was conducted according to ISO 14971:2007. Applicable biocompatibility testing was in accordance to the requirements of ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bond Strength*: 11.73 +/- 3.04
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.
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BioMers
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JUN 2 3 2010
10/3
510(k) Summary (per 21 CFR 807.92)
(per 21 CFR 807.92)
Applicant I. BioMers Products LLC. 18912 North Creek Parkway, Suite 210 Bothell, WA, 98011,
George Aliphtiras, Vice President of Business Contact Person: Development
Tel: 425-487-3000 Fax: 425-487-3813 Email: george@biomersbraces.com
March 15, 2010 Date Prepared:
II. Device Name
BioMers Translucent Orthodontic Bracket Proprietary Name: Orthodontic Plastic Bracket Common/ Usual Name: Orthodontic appliance and accessories Classification Name: 872.5470 Regulation Number: NJM Product Codes: Classification: II Classification Panel: Dental
III. Predicate Device
The BioMers Translucent Orthodontic Bracket is substantially equivalent to the Absolute bracket from Star Dentech Korea, Corp. and the PURE Sapphire bracket from Ortho Technology. The Absolute bracket was most recently cleared by the FDA on May 27, 2009 under 510(k) K090567. The PURE Sapphire bracket was cleared by the FDA on December 18, 2007 under 510(k) K073045.
Intended Use of the Device IV.
The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
V. Description of the Device
The Translucent Orthodontic Bracket is comprised of single crystal alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placement of an arch wire which applies the necessary
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BioMers
We Make You Smile
force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.
VI. Summary of the Technical Characteristics
The BioMers Orthodontic Bracket was designed and tested using ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure
The BioMers Translucent Orthodontic Bracket has similar technological characteristics as the predicate devices: Absolute bracket (Star Dentech Korea, Corp.) and PURE Sapphire bracket (Ortho Technology).
| BioMers Products | Star Dentech Korea | Ortho Technology | |
|---|---|---|---|
| Product Name | BioMers Translucent | ||
| Orthodontic Bracket | Absolute | PURE Sapphire | |
| 510(k) Number | Not assigned | K090567 | K073045 |
| Product Code(s) | NJM | NJM | NJM |
| Regulation # | 872.5470 | 872.5470 | 872.5470 |
| Class | II | II | II |
| Intended Use | Indicated for | ||
| orthodontic movement | |||
| of natural teeth, | |||
| excluding mandibular | |||
| bicuspid teeth. | Indicated for | ||
| orthodontic movement | |||
| of natural teeth, | |||
| excluding mandibular | |||
| bicuspid teeth. | Indicated for | ||
| orthodontic movement | |||
| of natural teeth, | |||
| excluding mandibular | |||
| bicuspid teeth. | |||
| Material | |||
| Composition | Al2O3 (single crystal | ||
| alumina) | Al2O3 (single crystal | ||
| alumina) | Al2O3 (single crystal | ||
| alumina) | |||
| Translucent | Yes | Yes | Yes |
| Standards | ISO 11405:2003 - | ||
| Dental materials -- | |||
| Testing of adhesion to | |||
| tooth structure | Not known | Not known | |
| Bracket Design | Twin bracket | Twin bracket | Twin bracket |
| Biocompatibility | Meets the applicable | ||
| requirements of ISO | |||
| 10993 | Meets the applicable | ||
| requirements of ISO | |||
| 10993 | Meets the applicable | ||
| requirements of ISO | |||
| 10993 | |||
| Available Slot | |||
| Sizes | 0.018", 0.022" | 0.018", 0.022" | 0.018", 0.022" |
| Available | |||
| Prescriptions | Standard-Edgewise, | ||
| Roth & High Torque | Roth & High Torque | Standard-Edgewise, | |
| Roth& High Torque | |||
| Bond Strength* | $11.73 \pm 3.04$ | $5.51 \pm 1.65$ | $19.41 \pm 5.08$ |
*Bond strength testing was carried out according to ISO 11405-2003(E).
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BioMers
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VII. Safety & Effectiveness
The Translucent Orthodontic Bracket has the same intended use and similar technological characteristics as the predicate devices. The differences in technological characteristics between the new device and the predicate device do not raise issues of safety and effectiveness of the Translucent Orthodontic Bracket. Bench tests and functional testing studies, according to ISO 11405:2003 - Dental materials -- Testing of adhesion to tooth structure were conducted. The risk analysis was conducted according to ISO 14971:2007. Applicable biocompatibility testing was in accordance to the requirements of ISO 10993-1.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a bird or a human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BioMers Products, LLC C/O Ms. Paula Wilkerson Intertek Testing, Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
JUN 2 3 2010
Re: K101481
Trade/Device Name: BioMers Translucent Orthodontic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: June 11, 2010 Received: June 14, 2010
Dear Ms. Wilkerson:
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.
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Page 2- Ms. Wilkerson
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.html 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 vours.
Susan Tanner
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioMers
R10170
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4. Indication for Use Statement
510(k) Number (if known):
BioMers Translucent Orthodontic Bracket
Indications for Use:
Device Name:
- The Translucent Orthodontic Bracket is indicated for orthodontic movement of . natural teeth, excluding mandibular bicuspid teeth.
Ken Huley for MSE
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101481
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)
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