(134 days)
No
The description focuses on the physical properties and mechanical function of a ceramic orthodontic bracket and does not mention any computational or data-driven aspects that would suggest AI/ML.
Yes
The device is used for the "orthodontic movement of teeth," which is a physiological process aimed at correcting dental malocclusions, thereby improving function and aesthetics. This falls under the definition of a therapeutic device as it treats a condition.
No
The device is an orthodontic bracket used for the movement of teeth; it does not diagnose any condition.
No
The device description clearly describes a physical orthodontic bracket made from polycrystalline alumina, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is an orthodontic bracket used for the mechanical movement of teeth. It is bonded directly to the teeth and interacts with an archwire to apply force.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. Its function is purely mechanical and applied directly to the patient's teeth.
The information provided describes a medical device used for treatment, not for diagnostic testing of biological samples.
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.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.
The Symetri Clear Debonding Instruments / Plier was included for informational purposes only, not for review for clearance.
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
Licensed Orthodontic / 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)
Non-clinical performance data included testing results for Torque Strength (also known as Wire Torque), Double Tie Wing Strength, Bond Strength Shear (also known as Shear Test), Bond Strength Tensile (also known as Tensile Strength), Wire Drag, Debonding Removal Fracture (also known as Bracket Removal Fracture), Hook Strength and Staining. The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices.
Metal Ligation and Double Tie bench testing was also conducted, however, not compared to a predicate.
Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance’s.
Symetri Clear brackets were inspected and met the dimensions itemized in ISO 27020. Dentistry - Brackets and tubes for use in orthodontics.
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.
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
January 31, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ormco Corporation Ms. Tara Bonny Senior Regulatory Affairs Specialist 1717 W. Collins Avenue Orange, California 92867
Re: K172845
Trade/Device Name: Symetri Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: December 20, 2017 Received: December 22, 2017
Dear Tara Bonny:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 -S
forTina 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) K172845
Device Name
Symetri™ Clear
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.
| 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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3
Image /page/3/Picture/0 description: The image shows the word "Ormco" in a bold, sans-serif font. The word is a dark blue color. There is a trademark symbol to the right of the word.
510(k) SUMMARY K172845
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 1. | 510(k) Submitter................................ | Ormco Corporation
1717 W. Collins Avenue
Orange, California 92867 |
|----|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact................................ | Tara Bonny
Regulatory Affairs
Phone: 909-962-5856
Fax: 909-962-5694
Email: Tara.Bonny@kavokerr.com |
| 3. | Additional Contact................................ | Valerie A. Cimmarusti
Vice President,
Regulatory Affairs & Design Assurance (RADA)
Phone: 714-516--7476
Fax: 909-962-5694
Email: Valerie.Cimmarusti@kavokerr.com |
| 4. | Date Prepared................................ | January 2, 2018 |
| 5. | Device | |
| | Proprietary Name................................ | Symetri™ Clear
Component of: Symetri™ Straight-Wire™ System |
| | Classification Name................................ | Bracket, Ceramic Dental |
| | Regulation Number................................ | 21 CFR 872.5470 |
| | Product Code................................ | NJM |
| | Medical Specialty Panel................................ | Dental |
| | Classification................................ | Medical Device, Class II |
Predicate Device 6.
Symetri Clear™ is substantially equivalent to 3M Unitek Corporation's Clarity™ ADVANCED Ceramic Brackets (K102803) cleared on February 17, 2011, product code NJM.
7. Reference Predicate Device
Damon™ 4Clear, K081415
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8. Device Description
Symetri Clear, is a single-use orthodontic bracket made from polycrystalline alumina. This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after Orthodontic treatment has been completed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. To aid with visual placement of the bracket to the tooth surface, the bracket has a removable, color coded, plastic axis indicator that is lifted away from the bracket following tooth placement or temporary color coded labial tie wings that are removed with a toothbrush and water. To identify tooth designation, the brackets include a temporary ink dot that is removed with a toothbrush and water after the brackets have been placed on the tooth. After the brackets are placed, an archwire is then inserted / threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Symetri Clear Debonding Instrument / Pliers. This step is also known as debonding.
The Symetri Clear Debonding Instruments / Plier was included for informational purposes only, not for review for clearance.
9. 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.
Although Symetri Clear's Indications for Use statement is not identical to the predicate devices, the minor differences in phrasing do not change the intended use.
10. Comparison of Technology
Symetri Clear is a non self-ligating, single-use orthodontic bracket's design has one-piece base and bracket construction, and is made from translucent alumina. To provide optional bond strength and effective bracket debonding, the base has a laseretched pattern. To ensure accurate placement, it uses a removable plastic component that is inserted into the horizontal and vertical slots of the bracket or temporary color which is incorporated into the labial surface instead of the plastic indicator. A temporary ink dot facilitates tooth designation. All ink is removed after the bracket has been placed on the tooth. The bracket is designed to remain intact during debonding.
As with Symetri Clear, the predicate device. Clarity ADVANCED, is also a non selfligating, single-use orthodontic bracket which has a one-piece base and bracket construction, and is made from translucent alumina. It also includes a temporary ink dot to facilitate tooth designation but does not include a removable plastic indicator for bracket placement. Bracket placement is achieved via temporary horizontal and vertical colored ink markers. Like Symetri Clear, all ink is removed after the bracket has been placed on the tooth. It also differs from Symetri Clear in its bracket base; it is a glassgrit, mechanical-locking base with a stress concentrator for predicable squeeze debonding. The stress concentrator on the base, causes the bracket to collapse during debonding by design.
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The reference predicate, Damon Clear2 (K081415), is also a single-use orthodontic bracket, with a one-piece base and bracket construction, and is made from translucent alumina. Similar to Symetri Clear, it utilizes a removable plastic indicator for tooth placement and a temporary ink dot for tooth designation. Unlike Symetri Clear and Clarity ADVANCED, this bracket is self-ligating.
Clarity ADVANCED (K102803), Damon Clear / Damon Clear2 (K081415) and Symetri Clear bracket systems (K172845), all offer a hand instrument accessory designed for bracket debonding. While the debonding process is not identical, these variations do not change the indications for use.
Symetri Clear shares the same indications for use as the primary and reference predicate devices. Differences between the devices do not raise any questions of safety and effectiveness.
11. Non-Clinical Performance Data
Non-clinical performance data included testing results for Torque Strength (also known as Wire Torque), Double Tie Wing Strength, Bond Strength Shear (also known as Shear Test), Bond Strength Tensile (also known as Tensile Strength), Wire Drag, Debonding Removal Fracture (also known as Bracket Removal Fracture), Hook Strength and Staining. The testing analysis shows that Symetri Clear brackets perform comparably to the predicate devices.
Metal Ligation and Double Tie bench testing was also conducted, however, not compared to a predicate.
Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance's.
Symetri Clear brackets were inspected and met the dimensions itemized in ISO 27020. Dentistry - Brackets and tubes for use in orthodontics.
| Element | Clarity™ ADVANCED
(K102803) | Damon Clear /
Damon Clear2
(K081415) | Symetri™ Clear
(K172845) |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K102803 | K081415 | K172845 |
| Trade Name | Clarity ADVANCED
Ceramic Brackets | Damon Clear /
Damon Clear2 | Symetri Clear |
| Target Users | Licensed Orthodontic /
Dental Professionals | Licensed Orthodontic /
Dental Professionals | Licensed Orthodontic /
Dental Professionals |
| Device
Description | Clarity ADVANCED is
a single-use
polycrystalline alumina | Damon Clear / Damon
Clear2 is a single-use
polycrystalline alumina | Symetri Clear is a
single-use
polycrystalline alumina |
| Element | Clarity™ ADVANCED
(K102803) | Damon Clear /
Damon Clear2
(K081415) | Symetri™ Clear
(K172845) |
| | orthodontic twin
bracket. | orthodontic self-ligating
bracket. | orthodontic twin
bracket. |
| Indications for
Use
(Identical to 510k) | Clarity ADVANCED
Ceramic Brackets are
intended for use in
orthodontic treatment.
The brackets are affixed
to teeth so that pressure
can be exerted on the
teeth. | Damon 4Clear* is a
bracket system intended
to aid in the movement
of patient teeth during
orthodontic treatment.
- Name at time of submission. | This device is intended
for the orthodontic
movement of teeth. It is
used temporarily and is
removed after
Orthodontic treatment
has been completed. |
| Common Name | Orthodontic Ceramic
Bracket | Orthodontic Ceramic
Bracket | Orthodontic Ceramic
Bracket |
| Classification
Name | Bracket, Ceramic,
Dental | Bracket, Ceramic,
Dental | Bracket, Ceramic,
Dental |
| Class | II | II | II |
| Product Code | NJM | NJM | NJM |
| Material | Alumina (Al2O3) | Alumina (Al2O3) | Alumina (Al2O3) |
| Clarity | Translucent | Translucent | Translucent |
| Bracket Design | 1-Piece Base and
Bracket Construction | 1-Piece Base and
Bracket Construction
and a slide | 1-Piece Base and
Bracket Construction |
| Ligation | Non Self-Ligating | Self-Ligating | Non Self-Ligating |
| Manufacturing
Method | CIM | CIM | CIM |
| Hooks | CIM Hooks | CIM Hooks | CIM Hooks |
| In/Out | .020"-.045" | .035" - .059" | .020" - .045" |
| Torque | +17° thru -17° | +2° thru -11° | +17° thru -17° |
| Angulation | Up to +8° | Up to +9° | Up to +8° |
| Rotation | Up to 2° | 0° | Up to 2° |
| Bracket
Identification
and Placement | Temporary color coded
placement indicator
system to aid in bracket
positioning
Temporary colored dot | Color coded plastic jig
to aid in visual
placement | Color coded plastic axis
indicator or temporary
color coded labial tie
wings to aid in visual
placement |
| | to indicate
Upper/Lower, Left/Right | Temporary colored dot
to indicate
Upper/Lower, Left/Right | Temporary colored dot
to indicate
Upper/Lower, Left/Right |
| Element | Clarity™ ADVANCED
(K102803) | Damon Clear /
Damon Clear2
(K081415) | Symetri™ Clear
(K172845) |
| Material
Composition for
Bracket
Identification
and Placement | Unknown | Bracket Identification –
Blue*:
-Polypropylene
Copolymer
- Copper, [29H, 31H-
Phthalocyaninato(2-)-
N29, N30, N31 - Titanium Dioxide
Bracket Identification –
Red*:
-Polypropylene
Copolymer
-Iron Oxide
-Zinc Stearate
Bracket Identification –
Temporary Acrylic
Paint*
-Polyethylene Glycol
Octylphenyl Ether
Per an independent
accredited medical
research service company,
the finished device is
considered to have met
biological evaluation and
risk assessment
requirements (ISO 10993
and ISO 14971). | Bracket Identification –
Blue:
-Polypropylene
Copolymer - Copper, [29H, 31H-
Phthalocyaninato(2-)-
N29, N30, N31 - Titanium Dioxide
Bracket Identification –
Red*:
-Polypropylene
Copolymer
-Iron Oxide
-Zinc Stearate
Bracket Identification –
Temporary Acrylic
Paint*
-Polyethylene Glycol
Octylphenyl Ether
*Per an independent
accredited medical
research service company,
the finished device is
considered to have met
biological evaluation and
risk assessment
requirements (ISO 10993
and ISO 14971). |
| Bracket Base | Micro-crystalline,
mechanical bonding,
surface for optimal bond
strength | Laser etch pattern
strategically cut onto the
bottom of the bracket for
optimal bond strength
between the bracket and
tooth | Laser etch pattern
strategically cut onto the
bottom of the bracket for
optimal bond strength
between the bracket and
tooth |
| Single Use | Yes | Yes | Yes |
| Non-Sterile
Packaging | Yes | Yes | Yes |
| Debonding Hand
Instrument
Accessory | Unitek Self-Ligating
Bracket Debonding | Damon Clear / Damon
Clear 2 Debonding | Symetri Clear
McLaughlin, Bennett &
Trevisi – Debonding |
| Element | Clarity TM ADVANCED
(K102803) | Damon Clear /
Damon Clear2
(K081415) | Symetri TM Clear
(K172845) |
| *Included for
informational
purposes only, not
for review for
clearance | Instrument
(REF: 804-170) | Instrument
(REF: 866-4019) | Instrument / Pliers
(REF: 866-4025) |
12. Predicate, Predicate Reference and Proposed Device Comparison
6
7
8
13. Clinical Performance Data
Clinical performance testing has not been performed for Symetri Clear.
Conclusion as to Substantial Equivalence 14.
Based upon similarities in the indications for use and technology, biocompatibility testing and performance testing, Symetri Clear brackets have been shown to be substantially equivalent to Clarity ADVANCED brackets (K102803) and to Damon Clear/Damon Clear2 brackets (K081415).