(123 days)
Not Found
No
The description focuses on the physical properties and intended use of ceramic orthodontic brackets, with no mention of AI or ML.
Yes
The device is described as being used in "orthodontic treatments" to "move the teeth to new positions" and correct "teeth alignment". This indicates a therapeutic purpose.
No
The device, "Edgewise and Roth Ceramic Brackets," is described as being "affixed to teeth so that pressure can be exerted on the teeth" in orthodontic treatments. Its function is to move teeth to new positions, which is a treatment modality, not a diagnostic one. There is no mention of the device being used to identify or detect a disease, condition, or state of a patient.
No
The device description clearly states it is a physical bracket made of translucent alumina, intended to be bonded to teeth. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Edgewise and Roth Ceramic Brackets are physical devices that are bonded to teeth to apply pressure and move them. They are used directly on the patient's body for a mechanical purpose.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is entirely external and mechanical.
Therefore, based on the provided information, the Edgewise and Roth Ceramic Brackets are not an In Vitro Diagnostic device. They are a type of orthodontic appliance.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
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.
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
Use only by professional orthodontists
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)
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.
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.
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.
0
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 |
| Brackets | |
| Date Prepared | April 15, 2013 |
| Submitter | DENTAL MORELLI LTDA |
| Alameda Jundiaí, 230 - | |
| Jardim Saira - Sorocaba | |
| CEP: 18085-090 | |
| Brazil | |
| Telephone: 55 (15) 3238-8200 | |
| Official Contact | Tara Conrad |
| TechLink International Consulting | |
| 18851 NE 29th Avenue | |
| Suite 720 | |
| Aventura, FL 33180 | |
| TEL- (305) 377-0077 | |
| Common Name | Orthodontic Ceramic Brackets |
| Trade Name | Edgewise Ceramic Brackets; Roth Ceramic |
| 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.
1
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
Brackets by Dental
Morelli | Roth Ceramic
Brackets by Dental
Morelli | Clarity Advance
Ceramic Brackets
by 3M Unitek
Corporation
K102803 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Clarity Advanced
Ceramic Brackets
are intended for
use in orthodontic
treatments. The
brackets are
affixed to teeth so
that pressure can
be exerted on the
teeth. |
| Target Population | Patients in need of
teeth alignment
correction | Patients in need of
teeth alignment
correction | Patients in need of
teeth alignment
correction |
| Anatomical Site | Teeth | Teeth | Teeth |
| Location of use | Use only by
professional
orthodontists | Use only by
professional
orthodontists | Use only by
professional
orthodontists |
| Materials | Aluminum oxide | Aluminum oxide | Aluminum oxide |
| Biocompatibility | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets |
| Compatibility with
the environment
and other devices | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets | Aluminum oxide is
medical grade and
is accepted for
ceramic brackets |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Maxillary In-out
(mm) | 0.94 | 0.6-1.2 | 0.53-.089 |
| Maxillary Torque | 0 | -7 to +8 | -7 to +17 |
| Maxillary
Angulation | 0 | 0 to +12 | 0 to +8 |
| Mandibular In-out
(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" |
2
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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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
Page 11 of 84 Traditional 510(k) Dental Morelli Ceramic Brackets