EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS

K131197 · Dental Morelli · NJM · Aug 27, 2013 · Dental

Device Facts

• Record ID: K131197
• Device Name: EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
• Applicant: Dental Morelli
• Product Code: NJM · Dental
• Decision Date: Aug 27, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Device Story

Orthodontic ceramic brackets; bonded to teeth by professional orthodontists using primer and adhesive. Device consists of translucent alumina body; non-self-bonding. Orthodontic wire inserted into bracket slots to exert pressure on teeth; facilitates tooth movement to desired positions. Used in clinical orthodontic settings. Benefits include correction of dental alignment.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility evaluation confirms medical-grade aluminum oxide is safe for use in ceramic brackets.

Technological Characteristics

Material: Aluminum oxide (ceramic). Form factor: Brackets with 0.022" slots. Non-sterile. Mechanical attachment via adhesive bonding. No electronic components or software.

Indications for Use

Indicated for patients in need of teeth alignment correction requiring orthodontic treatment. Contraindications not specified.

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

• Clarity Advanced Ceramic Brackets (K102803)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Morelli Ortodontia. The logo features a stylized "X" shape above the word "MORELLI" in bold, block letters. Below "MORELLI" is the word "ORTODONTIA" in smaller, block letters. A horizontal line is underneath the word "ORTODONTIA".

# Dental Morelli Ltda.

| SECTION 6 | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) SUMMARY | |
| Proprietary Name | Edgewise Ceramic Brackets; Roth Ceramic<br>Brackets |
| Date Prepared | April 15, 2013 |
| Submitter | DENTAL MORELLI LTDA<br>Alameda Jundiaí, 230 -<br>Jardim Saira - Sorocaba<br>CEP: 18085-090<br>Brazil<br>Telephone: [phone] |
| Official Contact | Tara Conrad<br>TechLink International Consulting<br>18851 NE 29th Avenue<br>Suite 720<br>Aventura, FL 33180<br>TEL- [phone] |
| Common Name | Orthodontic Ceramic Brackets |
| Trade Name | Edgewise Ceramic Brackets; Roth Ceramic<br>Brackets |
| Classification | Class II |
| Product Code | NJM |
| Classification Panel | Dental |
| Regulation Numbers | 21 CFR 872.5470 |
| Substantial Equivalence | K102803 Clarity Advanced Ceramic Brackets |

AUG 2 7 2013## Description of Proposed Device

Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.

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Image /page/1/Picture/0 description: The image shows the text "Dental Morelli Ltda." in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The background is plain white, which makes the text stand out prominently.

Image /page/1/Picture/1 description: The image shows a logo for a company called "Morelli Ortodontia". The logo consists of a stylized "X" shape above the company name. The "X" shape is made up of two curved lines that intersect in the middle. The company name is written in a bold, sans-serif font.

#### Indications for Use

Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

# Device Comparison Table

| | Edgewise Ceramic<br>Brackets by Dental<br>Morelli | Roth Ceramic<br>Brackets by Dental<br>Morelli | Clarity Advance<br>Ceramic Brackets<br>by 3M Unitek<br>Corporation<br>K102803 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Edgewise and Roth<br>Ceramic Brackets<br>are intended for<br>use in orthodontic<br>treatments. The<br>brackets are<br>affixed to teeth so<br>that pressure can<br>be exerted on the<br>teeth. | Edgewise and Roth<br>Ceramic Brackets<br>are intended for<br>use in orthodontic<br>treatments. The<br>brackets are<br>affixed to teeth so<br>that pressure can<br>be exerted on the<br>teeth. | Clarity Advanced<br>Ceramic Brackets<br>are intended for<br>use in orthodontic<br>treatments. The<br>brackets are<br>affixed to teeth so<br>that pressure can<br>be exerted on the<br>teeth. |
| Target Population | Patients in need of<br>teeth alignment<br>correction | Patients in need of<br>teeth alignment<br>correction | Patients in need of<br>teeth alignment<br>correction |
| Anatomical Site | Teeth | Teeth | Teeth |
| Location of use | Use only by<br>professional<br>orthodontists | Use only by<br>professional<br>orthodontists | Use only by<br>professional<br>orthodontists |
| Materials | Aluminum oxide | Aluminum oxide | Aluminum oxide |
| Biocompatibility | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets |
| Compatibility with<br>the environment<br>and other devices | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets | Aluminum oxide is<br>medical grade and<br>is accepted for<br>ceramic brackets |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Maxillary In-out<br>(mm) | 0.94 | 0.6-1.2 | 0.53-.089 |
| Maxillary Torque | 0 | -7 to +8 | -7 to +17 |
| Maxillary<br>Angulation | 0 | 0 to +12 | 0 to +8 |
| Mandibular In-out<br>(mm) | 0.94 | 0.6 - 1.2 | 0.51-1.14 |
| Mandibular Torque | 0 | -22 to 0 | -17 to 0 |
| Slot | 0.022" | 0.022" | 0.022" |

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Image /page/2/Picture/1 description: The image shows a logo for Morelli Ortodontia. The logo features a stylized "X" shape at the top, which is made up of geometric shapes. Below the "X" is the word "MORELLI" in a bold, sans-serif font, and below that is the word "ORTODONTIA" in a smaller, sans-serif font.

# Substantial Equivalence

Both the non-clinical data and the biocompatibility evaluation indicate that Edgewise and Roth Ceramic Brackets are safe and effective for their intended use in orthodontic treatment and perform as well as the predicate. The subject and predicate devices have the same intended use, indications for use, compositions, device design and performance.

# Device Material and Design

The body of the subject and predicate devices are composed of ceramic. The Edgewise and Roth Ceramic Bracket is not coated and does not have a liner. The Morelli Brackets have rounded edges and corners. The Edgewise and Roth Ceramic Bracket is not built to facilitate debonding.

## Conclusion

This premarket notification is being submitted to request clearance for the Edgewise and Roth Ceramic Brackets. The analysis on the Edgewise Ceramic Brackets demonstrates substantial equivalence to the 3M Unitek Corporation predicate.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### August 27, 2013

Dental Morelli Limited C/O Ms. Tara Conrad Regulatory Affairs Manager Techlink International Consultants 18851 NE 29th Avenue Suite 720 AVENTURA FL 33180

Re: K131197

Trade/Device Name: Edgewise Ceramic Brackets; Roth Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: May 15, 2013 Received: June 4, 2013

Dear Ms Conrad:

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 four of 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. Conrad

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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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K131197

#### Indications for Use Statement

Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

Perscription Use ____________ (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 NEED

Sheena A. Green -5
2013.08.27 14:29:58 -04-0000 for M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 131197

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

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