(225 days)
No
The device description and performance studies focus on the mechanical properties of the plastic brackets and accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as moving teeth to improve their alignment, which is a therapeutic purpose.
No
The device is described as an orthodontic appliance used for moving teeth to improve alignment, not for diagnosing any medical condition.
No
The device description clearly outlines physical components (plastic brackets, bracket caps, and buttons) that are bonded to teeth and interact with wires, indicating a hardware-based medical device.
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 mechanical action performed on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details physical components (brackets, caps, buttons) used to apply force to teeth. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties like tensile strength, elongation, and shear bond strength, which are relevant to the physical function of the device, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
DYW
Device Description
The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC PLASTIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred positions can be used with bracket caps. The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES consist of plastic orthodontic brackets, bracket caps, and buttons. The bracket caps are designed as an accessory of the orthodontic brackets for holding the archwire in the bracket's slot. Bracket caps are placed on the labial/buccal side of the brackets. The plastic buttons are designed to move teeth to improve their alignment. The plastic buttons are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. The button design includes a round slot for attaching wires or other appliances.
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
dental professionals
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)
The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES were successfully tested for Tensile Strength, Elongation, and Shear Bond Strength. The tensile and elongation tests were performed to determine no significant deterioration with aging. New and aged brackets exceeded the criteria of >=50 MPa for tensile strength and >= 100% elongation. The average shear bond strengths were greater than 100 N for wet and dry conditions, which exceeded the internal test criteria for shear bond strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tensile Strength: >=50 MPa
Elongation: >=100%
Shear Bond Strength: >100 N
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and white and includes the words "U.S. Food & Drug Administration."
TOMY, Inc. % Ruthanne Vendy Principal Specialist Regulatory & Ouality Solutions, Inc. 2790 Mosside Blvd. #800 Monroeville, Pennsylvania 15146
October 30, 2018
Re: K180718
Trade/Device Name: Orthodontic Plastic Bracket and Accessories Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW Dated: August 22, 2018 Received: August 29, 2018
Dear Ruthanne Vendy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S3
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
2
Indications for Use
510(k) Number (if known) K180718
Device Name ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
Indications for Use (Describe) ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for TOMY Inc. The logo consists of the word "TOMY" in bold, black letters, followed by the word "Inc." in a smaller font size. To the left of the word "TOMY" is a circular graphic with the word "TOMY" written inside.
510(k) Summary K180718
Date Prepared: October 25, 2018
I. SUBMITTER
TOMY, Inc. Tenko Bldg. 3-16-7 Midori-cho, Fuchu City, Tokyo 183-0006 Japan
PHONE: 81-42-363-1151 FAX #: 81-42-363-1191
Contact: Mr. Jinichi Watanabe
II. DEVICE
Primary Classification: Name of Device: ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES Common or Usual Name: Bracket, Plastic, Orthodontic Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II Product Code: DYW
III. PREDICATE AND REFERENCE DEVICES
DENTSPLY Elation MB Metal Reinforced Plastic Brackets, K092030 (Primary Predicate) CDB Corporation CDB Clip, K080906 GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket, K053055 DENTSPLY NEO-CLIP Orthodontic Bracket Accessory, K042905
IV. DEVICE DESCRIPTION
The ORTHODONTIC PLASTIC BRACKETS are designed to move teeth to improve their alignment. The ORTHODONTIC PLASTIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred positions can be used with bracket caps. The ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES consist of plastic orthodontic brackets, bracket caps, and buttons. The bracket caps are designed as an accessory of the orthodontic brackets for holding the archwire in the bracket's slot. Bracket caps are placed on the labial/buccal side of the brackets. The plastic buttons are designed to move teeth to improve their alignment. The plastic buttons are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. The button design includes a round slot for attaching wires or other appliances.
V. INDICATIONS FOR USE: ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.
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Image /page/4/Picture/0 description: The image shows the logo for TOMY Inc. The logo consists of the TOMY logo on the left and the text "TOMY Inc." on the right. The TOMY logo is a stylized version of the company's name. The text "TOMY Inc." is in a bold, sans-serif font.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The below tables (Tables VI-1, VI-2 and VI-3) provide a comparison of the subject devices and the predicate devices. Table VI-1 is a comparison of the brackets; Table VI-2 is a comparison of the bracket caps; and Table VI-3 is a comparison of the bracket buttons.
Table VI-1 Comparison of DENTSPLY ELATION MB Metal Reinforced Plastic Bracket (K092030) to Subject ORTHODONTIC PLASTIC BRACKETS
| | ORTHODONTIC PLASTIC BRACKETS (Subject) | DENTSPLY ELATION MB Metal Reinforced
Plastic Bracket (K092030) | Equivalence
Analysis |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications
for Use | ORTHODONTIC PLASTIC BRACKETS AND
ACCESSORIES are indicated for orthodontic
movement of natural teeth. | Elation MB is indicated for orthodontic
movement of natural teeth. | Substantially
Equivalent |
| Device
Name
Description | Device: Bracket, Plastic, Orthodontic
Regulation Description: Orthodontic plastic
bracket
Definition: 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. | Device: Bracket, Plastic, Orthodontic
Regulation Description: Orthodontic plastic
bracket
Definition: 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. | Substantially
Equivalent |
| Medical
Specialty
Product
Code
Reg Number
Class | Regulation Medical Specialty: Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Regulation Medical Specialty: Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | |
| Patient
Contact
Materials | Made of Polycarbonate, Polyethylene
terephthalate, Polybutylene terephthalate,
and Stainless Steel AISI 304 | Made of Polycarbonate, Polyethylene
terephthalate, Polybutylene terephthalate, and
Stainless Steel AISI 304 | Substantially
Equivalent |
| Sterility | Non-Sterile | Non-Sterile | Substantially
Equivalent |
| Sterilization | Not to be sterilized | Not to be sterilized | Substantially
Equivalent |
| Utility | Single Use Only | Single Use Only | Substantially
Equivalent |
| Energy
Source | Manually operated-Non-electrical | Manually operated—Non-electrical | Substantially
Equivalent |
| Visual
Identificatio
n for tooth
placement | A color dot is applied to the distogingival tie-
wing for visual identification.
Color Codes:
UR & UL CENTRALS: BLUE
UR & UL LATERALS: PINK
UR & UL CUSPIDS: GREEN
UR & UL BICUSPIDS: VIOLET
LOWER ANTERIORS: ORANGE
LR & LL CUSPIDS: LIGHT BLUE
LR & LL 1st BICUSPIDS: GREY
LR & LL 2nd BICUSPIDS: BLACK | A color dot is applied to the distogingival tie-
wing for visual identification.
Color Codes:
U1 Blue
U2 Pink
U3 Green
U4-5 Violet
L1-2 Orange
L3 Light Blue
L4 Grey
L5 Black | Substantially
Equivalent |
| Application
to teeth | Bonded | Bonded | Substantially
Equivalent |
| Manufacturi
ng Method | Injection Molded | Injection Molded | Substantially
Equivalent |
| Mechanical
Lock Base | Yes | Yes | Substantially
Equivalent |
| | ORTHODONTIC PLASTIC BRACKETS (Subject) | DENTSPLY ELATION MB Metal Reinforced
Plastic Bracket (K092030) | Equivalence
Analysis |
| Metal
Reinforced | Yes | Yes | Substantially
Equivalent |
| Picture of
Device
(BRACKET) | Image: ORTHODONTIC PLASTIC BRACKETS | Image: DENTSPLY ELATION MB Metal Reinforced Plastic Bracket | |
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Image /page/5/Picture/0 description: The image shows the logo for TOMY Inc. The logo consists of the TOMY logo on the left and the text "TOMY Inc." on the right. The TOMY logo is a stylized version of the company's name. The text "TOMY Inc." is written in a bold, sans-serif font.
Table VI-2 Comparison of CDB CORPORATION CDB CLIP (K080906) to Subject ORTHODONTIC PLASTIC BRACKET CAPS
| | ORTHODONTIC PLASTIC BRACKET CAPS
(Subject) | CDB CORPORATION
CDB CLIP (K080906)1 | Equivalence
Analysis | |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications
for Use | ORTHODONTIC PLASTIC BRACKETS AND
ACCESSORIES are indicated for orthodontic
movement of natural teeth. | 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. | Substantially
Equivalent | |
| Device
Name
Description
Medical
Specialty
Product
Code
Reg Number
Class | Device: Bracket, Plastic, Orthodontic
Regulation Description: Orthodontic plastic
bracket
Definition: 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.
Regulation Medical Specialty: Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Device: Bracket, Ceramic, Orthodontic
Regulation Description: Orthodontic plastic
bracket
Definition: An orthodontic ceramic bracket is
a device composed of ceramic, which is
intended to be bonded to a tooth, upon which
an orthodontic wire is used to move the tooth
to a new postion. (the current classification
only specifies plastic brackets. Confusion
exists as to whether ceramic brackets are
regulated.)
Regulation Medical Specialty: Dental
Review Panel: Dental
Product Code: NJM
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Product
Codes are
different,
however the
devices are
under the
same
regulation | |
| Patient
Contact
Materials | Polyoxymethylene acetyl polymer | Polyoxymethylene acetyl polymer | Substantially
Equivalent | |
| Sterility | Non-Sterile | Non-Sterile | Substantially
Equivalent | |
| Sterilization | Not to be sterilized | Not to be sterilized | Substantially
Equivalent | |
| Utility | Single Use Only | Single Use Only | Substantially
Equivalent | |
| Energy
Source | Manually operated—Non-electrical | Manually operated—Non-electrical | Substantially
Equivalent | |
| Manufacturi
ng Method | Injection Molded | Injection Molded | Substantially
Equivalent | |
| Picture of
Device (CAP) | Image: Orthodontic plastic bracket caps | Image Unavailable | Substantially
Equivalent | |
| 1 K080906 CDB Clip is identical to the Dentsply International K042905 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY. There is no difference in the | | | | |
| | ORTHODONTIC PLASTIC
BUTTONS (Subject) | DENTSPLY ELATION MB
Metal Reinforced Plastic
Bracket (K092030) | GESTENCO INTERNATIONAL
AB ORTHODONTIC POLYMER
COMPOSITE BRACKET
(K053055) | Equivalence
Analysis |
| Indications
for Use | ORTHODONTIC PLASTIC
BRACKETS AND ACCESSORIES
are indicated for orthodontic
movement of natural teeth. | Elation MB is indicated for
orthodontic movement of
natural teeth. | Orthodontic Polymer
Composite Bracket is
intended to be bonded on
teeth to aid in the
movement of patient's teeth
during orthodontic
treatment. | Substantially
Equivalent |
| Device
Name
Description
Medical
Specialty
Product
Code
Reg Number
Class | Device: Bracket, Plastic,
Orthodontic
Regulation Description:
Orthodontic plastic bracket
Definition: 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.
Regulation Medical Specialty:
Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Device: Bracket, Plastic,
Orthodontic
Regulation Description:
Orthodontic plastic bracket
Definition: 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.
Regulation Medical Specialty:
Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Device: Bracket, Plastic,
Orthodontic
Regulation Description:
Orthodontic plastic bracket
Definition: 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.
Regulation Medical Specialty:
Dental
Review Panel: Dental
Product Code: DYW
Submission Type: 510(k)
Regulation Number: 872.5470
Device Class: 2 | Substantially
Equivalent |
| Patient
Contact
Materials | Polycarbonate, Polyethylene
terephthalate, Polybutylene
terephthalate | Made of Polycarbonate,
Polyethylene terephthalate,
Polybutylene terephthalate,
and Stainless Steel AISI 304 | Polycarbonate | Substantially
Equivalent to
K092030 |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Substantially
Equivalent |
| Sterilization | Not to be sterilized | Not to be sterilized | Not to be sterilized | Substantially
Equivalent |
| Utility | Single Use Only | Single Use Only | Single Use Only | Substantially
Equivalent |
| Energy
Source | Manually operated-Non-
electrical | Manually operated-Non-
electrical | Manually operated-Non-
electrical | Substantially
Equivalent |
| Manufacturi
ng Method | Injection Molded | Injection Molded | Injection Molded | Substantially
Equivalent |
| Picture of
Device | Image: Orthodontic Plastic Buttons | Image: Dentsply Elation MB Metal Reinforced Plastic Bracket | Image: Gestenco International AB Orthodontic Polymer Composite Bracket | |
fundamental technology. The CDB Clip is made of the same material and has the same overall intended use.
6
Table VI-3 Comparison of GESTENCO INTERNATIONAL AB ORTHODONTIC POLYMER COMPOSITE BRACKET (K053055) to Subject ORTHODONTIC PLASTIC BRACKET BUTTONS
VII. PERFORMANCE DATA
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES conform to the following Recognized Consensus
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES TOMY, Inc.
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Image /page/7/Picture/0 description: The image shows the logo for TOMY Inc. The logo consists of the word "TOMY" in a bold, sans-serif font, followed by "Inc." in a smaller font. To the left of the word "TOMY" is a stylized graphic, possibly representing the company's initials.
Standards:
- . ISO 27020 First edition 2010-12-15 "Dentistry - Brackets and Tubes for use in Orthodontics"
- ISO 7405: 2008 "Dentistry Evaluation of biocompatibility of medical devices used in dentistry" O
- ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Additionally, the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES were successfully tested for Tensile Strength, Elongation, and Shear Bond Strength. The tensile and elongation tests were performed to determine no significant deterioration with aging. New and aged brackets exceeded the criteria of ≥50 MPa for tensile strength and ≥ 100% elongation. The average shear bond strengths were greater than 100 N for wet and dry conditions, which exceeded the internal test criteria for shear bond strength.
All the components and manufacturing processes found in the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are identical to the materials used in legally marketed devices (DENTSPLY ELATION MB Metal Reinforced Plastic Bracket [K092030] and DENTSPLY NEO-CLIP ORTHODONTIC BRACKET ACCESSORY [K042905]) and/or were found acceptable for dental use. ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are the same and/or of the equivalent composition as the predicate devices. Therefore, further biocompatibility testing is not necessary.
No animal studies or clinical testing were required for these devices.
VIII. CONCLUSIONS
There are no substantial differences in terms of composition and mechanical properties between the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES and the predicate devices. The indications for use are comparable and any differences in technological characteristics do not raise any new questions of substantial equivalence. Therefore, we believe that the information provided herein demonstrates that the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are substantially equivalent to the predicate and reference devices in design, principle of performance, and intended use.