Who is the manufacturer of ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

Tomy, Inc. filed the 510(k) submission for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (K180718).

What is the FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

DYW. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

K180718 · Tomy, Inc. · DYW · Oct 30, 2018 · Dental

Device Facts

Record ID	K180718
Device Name	ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
Applicant	Tomy, Inc.
Product Code	DYW · Dental
Decision Date	Oct 30, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES are indicated for orthodontic movement of natural teeth.

Device Story

Orthodontic plastic brackets, caps, and buttons; bonded to natural teeth by dental professionals; connect with orthodontic wires to apply pressure for tooth movement; bracket caps hold archwire in bracket slot; buttons provide attachment point for wires/appliances; used in clinical dental settings; manual operation; non-electrical; single-use; provides mechanical force for tooth alignment; benefits patient by correcting tooth position.

Clinical Evidence

Bench testing only. No clinical or animal studies performed. Testing included tensile strength (≥50 MPa), elongation (≥100%), and shear bond strength (>100 N in wet/dry conditions). Biocompatibility supported by equivalence to predicate materials.

Technological Characteristics

Materials: Polycarbonate, polyethylene terephthalate, polybutylene terephthalate, stainless steel AISI 304. Non-electrical, manually operated. Injection molded. Single-use. Non-sterile. Standards: ISO 27020, ISO 7405, ISO 10993-1.

Indications for Use

Indicated for orthodontic movement of natural teeth in patients requiring orthodontic treatment.

Regulatory Classification

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.

Predicate Devices

DENTSPLY Elation MB Metal Reinforced Plastic Brackets (K092030)
CDB Corporation CDB Clip (K080906)
GESTENCO INTERNATIONAL AB Orthodontic Polymer Composite Bracket (K053055)
DENTSPLY NEO-CLIP Orthodontic Bracket Accessory (K042905)

Submission Summary (Full Text)

{0}------------------------------------------------ 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 | | {5}------------------------------------------------ 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. {7}------------------------------------------------ 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.

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Identification

Predicate Devices

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ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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