(297 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical screw, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is used as a temporary anchor for orthodontic treatment, which is a therapeutic intervention aimed at correcting dental irregularities.
No
Explanation: The ATOZ Mini-Screw is described as a temporary anchor used for orthodontic treatment, serving as a fixing point. Its function is mechanical and structural (holding something in place), not to gather information about a patient's health status or diagnose a condition.
No
The device description clearly states it is a physical screw made of Titanium Alloy, intended for use as a temporary anchor in orthodontic treatment. It is a hardware device.
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. This testing is done outside of the body (in vitro).
- ATOZ Mini-Screw Function: The ATOZ Mini-Screw is a physical device implanted into the body (in vivo) to serve as a temporary anchor for orthodontic treatment. It does not analyze biological samples.
The description clearly indicates it's a surgical implant used directly in the patient's mouth for mechanical support during orthodontic procedures. This falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.
Product codes
OAT
Device Description
The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver.
The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied.
The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is single-use only and may not be reused.
The screw is designed to withstand the external force sufficiently during orthodontic treatment of the screw, and its mechanical performance has been evaluated according to ISO 19023 and ASTM F543.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following bench test and biocompatibility were conducted using the ATOZ Mini-Screw, demonstrating the device as substantially equivalent to the previously cleared predicate device.
Bench Test: The test items below to measure the mechanical strength of the ATOZ Mini-Screw were performed according to ISO 19023 and ASTM 543.
- Torque strength
- Torsional strength
- Pullout strength
Biocompatibility: The subject device is manufactured from Titanium alloy (conforming with ASTM F136). The tests below were conducted to demonstrate biocompatibility of this device according to ISO 10993-1:2018.
- In vitro Cytotoxicity (ISO 10993-5:2009)
- Skin Sensitization (ISO 10993-10:2010)
- Oral mucosa irritation (ISO 10993-10:2010)
- Acute systemic toxicity study (ISO 1093-11:2017)
- Chemical analysis test (ISO 10993-18:2020)
- Biological Safety Assessment
Sterilization: The subject device is provided Non-Sterile. The end user must sterilize according to the recommended parameters (121 degrees/30 minutes sterilization, 30 minutes drying) using an autoclave before use. In this sterilization parameter, the subject device meets Sterility Assurance Level of 1E-6 and has been verified according to the standards below.
- ISO 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ISO/TS 17665-2:2009, Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
- ISO 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-3: 2017, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes
- ISO 11737-1:2018, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
- ISO 11737-2:2019, Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterility assurance in health care facilities
Clinical Data was not required to demonstrate the substantial equivalence.
Key results: The ATOZ Mini-Screw and predicate device have the same indication for use, the same raw materials and the same characteristics. In addition, the substantial equivalence of the subject device was confirmed through a non-clinical testing. Therefore, the ATOZ Mini-Screw has been proven to be equivalent to a predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains 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 is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MK Meditech Inc. Sungchul Moon Representative Room# 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si. Gyeonggi-do 13449 KOREA. SOUTH
Re: K210559
Trade/Device Name: ATOZ Mini-Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: August 2, 2021 Received: November 18, 2021
Dear Sungchul Moon:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
12/19/21
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210559
Device Name ATOZ Mini-Screw
Indications for Use (Describe)
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.
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
510(k) Summary
K210559
1. Submitter Information
| Manufacturer: | MK Meditech Inc.
Room # 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, 13449,
Korea. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | SungChul Moon, Ph.D.
Representative of MK Meditech Inc.
Tel+82-31-759-2885, (Fax) +82-31-759-2886
e-mail: orthofor@chol.com |
| Date Prepared: | December 17, 2021 |
2. Device Information
| Trade Name: | ATOZ Mini-Screw |
|---|---|
| Model Number: | MKS-1608, MKS-1609, MKS-1610, MKS-1611, MKS-1612, MKS-1613, |
| MKS-1614, MKS-1615 and MKS-1616 | |
| Common Name: | Orthodontic Anchor Screw |
| Product Code: | OAT (Implant, Endosseous, Orthodontic) |
| Regulation Number: | 21CFR 872.3640 |
| Class: | 2 |
3. Predicate Device Information
| Predicate Device: | K161335 (Dual Top Screw System) |
|---|---|
| Reference Device: | K063495 (C, CT and Special Type Orthodontic Anchor Screws) |
4. Description of the Device
The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver.
The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied.
4
The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is single-use only and may not be reused.
The screw is designed to withstand the external force sufficiently during orthodontic treatment of the screw, and its mechanical performance has been evaluated according to ISO 19023 and ASTM F543.
న. Indication for Use
The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.
6. Technological Characteristics
The subject device has the same purpose and raw materials as the predicate device. The design of the screw differs in diameter and length and the shape of the head.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | K210559 | K161335 | K063495 |
| Product Name | ATOZ Mini-Screw | Dual Top Screw System | The C-Type, CT Type and |
| Special Type Orthodontic | |||
| Anchor Screws | |||
| Product Code | OAT | OAT | OAT |
| Manufacturer | MK Meditech Inc. | Jeil Medical Corporation | Biomaterials Korea |
| Incorporated | |||
| Indication for Use | The ATOZ Mini-Screw is | ||
| intended for use as a | |||
| temporary anchor for | |||
| orthodontic treatment. | The Dual Top Screw | ||
| System is intended for use | |||
| as a temporary anchor for | |||
| orthodontic treatment for | |||
| use in patients aged 12 | |||
| and older. | Intended for use as a | ||
| temporary anchor for | |||
| orthodontic treatment. | |||
| Material | Titanium Alloy | ||
| (ASTM F136) | Titanium Alloy | ||
| (ASTM F136) | Titanium Alloy | ||
| (ASTM F136) | |||
| Surface Treatment | No surface treatment | No surface treatment | Anodized |
| Design | Screw |
- Thread Diameter:
Ø 1.6mm - Thread Depth:
0.54mm - Length:
8mm~16mm | Screw - Thread Diameter:
Ø 1.3~Ø 2.5mm - Thread Depth:
0.15~0.55mm - Length:
5~16mm | Screw - Thread Diameter:
Ø 1.2~Ø 2.0mm - Thread Depth:
0.14mm - Length:
5~12mm |
| Sterilization | Non-Sterile
(Steam sterilized by user) | Non-Sterile
(Steam sterilized by user)
or Gamma- Sterilized | Non-Sterile
(Steam sterilized by user) |
7. Summary of Non-Clinical Data
The following bench test and biocompatibility were conducted using the ATOZ Mini-Screw, demonstrating the device as substantially equivalent to the previously cleared predicate device.
5
O Bench Test
The test items below to measure the mechanical strength of the ATOZ Mini-Screw were performed according to ISO 19023 and ASTM 543.
- Torque strength ●
- Torsional strength
- Pullout strength
- o Biocompatibility
The subject device is manufactured from Titanium alloy (conforming with ASTM F136). The tests below were conducted to demonstrate biocompatibility of this device according to ISO 10993-1:2018.
- In vitro Cytotoxicity (ISO 10993-5:2009) ●
- Skin Sensitization (ISO 10993-10:2010) ●
- Oral mucosa irritation (ISO 10993-10:2010)
- Acute systemic toxicity study (ISO 1093-11:2017)
- Chemical analysis test (ISO 10993-18:2020) ●
- Biological Safety Assessment
- o Sterilization
The subject device is provided Non-Sterile. The end user must sterilize according to the recommended parameters (121 degrees/30 minutes sterilization, 30 minutes drying) using an autoclave before use. In this sterilization parameter, the subject device meets Sterility Assurance Level of 1E-6 and has been verified according to the standards below.
- ISO 17665-1:2006, Sterilization of health care products Moist heat Part 1: Requirements for the ● development, validation, and routine control of a sterilization process for medical devices
- ISO/TS 17665-2:2009, Sterilization of health care products Moist heat Part 2: Guidance on the . application of ISO 17665-1
- ISO 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General . requirements
- ISO 11138-3: 2017, Sterilization of health care products Biological indicators Part 3: Biological ● indicators for moist heat sterilization processes
- ISO 11737-1:2018, Sterilization of medical devices Microbiological methods Part 1: ● Determination of a population of microorganisms on products
- ISO 11737-2:2019, Sterilization of health care products Microbiological methods Part 2: Tests ● of sterility performed in the definition, validation and maintenance of a sterilization process
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterility assurance in health care facilities
10. Summary of Clinical Data
Clinical Data was not required to demonstrate the substantial equivalence
11. Conclusion
The ATOZ Mini-Screw and predicate device have the same indication for use, the same raw materials and the same characteristics. In addition, the substantial equivalence of the subject device was confirmed through a non-clinical testing. Therefore, the ATOZ Mini-Screw has been proven to be equivalent to a predicate device.