(317 days)
Not Found
No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is not intended to treat or cure a disease or condition directly.
No
The device is an orthodontic implant used as an anchorage point for facilitating tooth movement, not for diagnosing conditions. Its function is interventional, not diagnostic.
No
The device description clearly states it is an "implantable medical device" and a "threaded titanium dental implant screw," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Dental Morelli Orthodontic Dental Implant is a "threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances." It is an implantable device used directly in the body.
- Intended Use: The intended use is to facilitate orthodontic movement of teeth by providing an anchorage point. This is a mechanical function within the body, not a diagnostic test performed on a sample outside the body.
Therefore, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Orthodontic Miniscrew for Absolute Anchorage is threaded titanium dental imo ort screws intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
Product codes (comma separated list FDA assigned to the subject device)
OAT
Device Description
The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use only by professional dentists / 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)
Testing was done to determine the torque levels, forces and insertion lengths while inserting the Orthodontic Miniscrew for Absolute Anchorage. The level of torque is comparable to the Aarhus Anchorage System K041527. Which were investigated with the measurement equipment under the same parameter. In conclusion it can be said that in all respects based on Intended Use, Indications of Use, Construction Material, Performance and Bench Tests that the Orthodontic Miniscrew for Absolute Anchorage and the Aarhus Anchorage System K041527 are substantially equivalent.
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.
Aarhus Anchorage System K041527
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows a logo for Morelli Ortodontia. The logo features a stylized symbol above the text. The symbol is an abstract design with intersecting lines and curved elements, resembling a stylized "X". Below the symbol, the word "Morelli" is written in a bold, stylized font, and below that, the word "Ortodontia" is written in a smaller, simpler font.
Dental Morelli Ltda.
SECTION 7
510(k) SUMMARY
Proprietary Name
Date Prepared
Orthodontic Miniscrew for Absolute Anchorage
December 1, 2013
Submitter
DENTAL MORELLI LTDA Alameda Jundiaí, 230 -Jardim Saira - Sorocaba CEP: 18085-090 Brazil Telephone: 55 (15) 3238-8200
Official Contact
Lilian Llull / Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180 TEL- (305) 377-0077
Common Name Classification Name Requlation Number & Product Codes Proposed Requilatory Class Predicate Device Identification
Orthodontic Mini Implants Endosseous Orthopedic Implants OAT - 21 CFR 872.3640 Class II Aarhus Anchorage System K041527
Description of Proposed Device
The Orthodontic Miniscrew for Absolute Anchorage is an implantable medical device used as a temporary skeletal anchorage point for orthodontic movements. The mini screw is intended to receive low intensity static clinical loads. Maximum dynamic forces may occur at low frequencies for short periods; which is inadequate to compromise the performance of the product through fatigue. The device is available in different lengths (6, 8, 10, mm), diameter 1.5 mm, and supplied in sealed sterile polyethylene bags.
Intended Use
The Orthodontic Miniscrew for Absolute Anchorage is threaded titanium dental imo ort screws intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
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1
Image /page/1/Picture/0 description: The image shows a logo with a stylized "X" shape at the top. Below the "X" is the word "MORELLI" in a bold, stylized font. Underneath "MORELLI" is the word "ORTODONTIA" in a smaller, less bold font.
Device Comparison
・
.
.
| | Orthodontic Miniscrew for Absolute Anchorage by Dental
Morelli K130476 | Aarhus Anchorage System
K041527 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications of Use | Threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily | Threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily |
| Target Population | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction |
| Anatomical Sites | Jaw | Jaw |
| Location of Use, hospital, home, ambulance, etc | Use only by professional dentists / orthodontists | Use only by professional dentists / orthodontists |
| Diameter and Length | Diameter ranges from 1.5 mm, length ranges from 6-10 mm | Diameter ranges from 1.5-2 mm, length ranges from 9-11 mm |
| Performance | Self-trapping/Self-drilling | Self-trapping/Self-drilling |
| Materials | Titanium Alloy ASTM F 136 | Titanium Alloy ASTM F 136 |
| Biocompatibility | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant |
| Compatibility with the environment and other devices | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant | Titanium Alloy in medical grade according to ASTM-F 136 is accepted for endosseous implant |
| Sterility | Gamma Radiation | Gamma Radiation |
| Mechanical Safety | Tensile strength of material according to ASTM - F 136 is accepted for endosseous implants | Tensile strength of material according to ASTM - F 136 is accepted for endosseous implants |
·
.
2
Dental Morelli Ltda.
Image /page/2/Picture/1 description: The image shows a logo with the word "MORELLI" in a bold, stylized font above the word "ORTODONTIA" in a smaller, less bold font. Above the words is a geometric design that resembles an "X" shape, with each arm of the "X" having a block at the end and a curved section in the middle. The logo appears to be for a company or product related to orthodontics.
Substantial Equivalence
The Orthodontic Miniscrew for Absolute Anchorage is made from the same material as the predicate Aarhus Anchorage System K041527 and has similar dimensions and characteristics. Micro Titanium Plate System following ASTMF 136-98 which is generally used in this kind of bone screw therefore no further testing was conducted.
All reports show that the Orthodontic Miniscrew for Absolute Anchorage is substantially equivalent in design, material, intended use and function to Aarhus Anchorage System K041527. They are made of the same material and have similar dimensions and characteristics. Potential adverse effects are identical. Both devices are manufactured from titanium ASTMF 136-98 which is generally used in this kind of bone screw.
Performance Testing
The Orthodontic Miniscrew for Absolute Anchorage conforms to the following . standards:
- ASTM F136 .
- ASTM F1980-07 .
- ISO 11137 �
ASTM F136: This specification covers the chemical, mechanical, and metallurgical reguirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in the manufacture of surgical implants. The products are classified into: strip, sheet, plate, bar, forging bar, and wire. The heat analysis shall conform to the chemical composition requirements specified. Product analysis tolerances do not broaden the specified heat analysis requirements but cover variations between laboratories in the measurement of chemical content. Tension test and bend test shall be performed to meet the requirements specified.
ASTM F1980-07: The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time and by subsequent dynamic events during shipping and handling.
ISO 11137: Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the
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K130476
3
Image /page/3/Picture/0 description: The image shows a logo for Morelli Ortodontia. The logo consists of a stylized "X" shape above the word "MORELLI" in a bold, sans-serif font. Below "MORELLI" is the word "ORTODONTIA" in a smaller, sans-serif font. The logo is black and white.
Dental Morelli Ltda.
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products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices.
Conclusion
Testing was done to determine the torque levels, forces and insertion lengths while inserting the Orthodontic Miniscrew for Absolute Anchorage. The level of torque is comparable to the Aarhus Anchorage System K041527. Which were investigated with the measurement equipment under the same parameter. In conclusion it can be said that in all respects based on Intended Use, Indications of Use, Construction Material, Performance and Bench Tests that the Orthodontic Miniscrew for Absolute Anchorage and the Aarhus Anchorage System K041527 are substantially equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2014
DENTAL MORELLI LTDA C/O Ms. Lillian Llull Senior Partner TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
Re: K130476
Trade/Device Name: Orthodontic Miniscrew for Absolute Anchorage Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 1, 2013 Received: December 6, 2013
Dear Ms. Llull:
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,
5
Page 2 - Ms. Llull
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,
Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer-S" in bold, black font. The text is arranged in two lines, with "Kwame O." on the first line and "Ulmer-S" on the second line. There is some noise and artifacts around the text, possibly due to the image quality or scanning process.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number: K130476
Device Name: Orthodontic Miniscrew for Absolute Anchorage
Indications for Use:
Dental Morelli Orthodontic Dental Implant is a threaded titanium dental implant screw intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment.
X Prescription 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
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
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