(156 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical orthodontic screw, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used to facilitate orthodontic movement of teeth, which is a structural correction rather than the treatment of a disease or condition. While it aids in a medical procedure, its function isn't directly therapeutic in the sense of healing or curing a pathology.
No
The documentation describes the Orthodontic Screw as a device used as a fixed anchorage point for orthodontic appliances. It is a physical implant to facilitate tooth movement during orthodontic treatment, not designed to diagnose medical conditions.
No
The device description clearly states it is a dental implant system made of titanium metal, describing physical dimensions and material composition. This indicates a hardware device, not software only.
No, 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. These tests are performed outside of the body (in vitro).
- Device Description: The provided description clearly states that the Orthodontic Screw is a dental implant system made of titanium metal. It is physically implanted into the bone to serve as an anchorage point.
- Intended Use: The intended use is to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed within the body.
The device is a surgical implant used in dentistry, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Product codes
OAT
Device Description
The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.
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)
Nonclinical testing:
Fracture load test was done in accordance with Osstem standard (Fracture & Bending test. OS-C-0013) and result is in compliance with it.
Rotational Fracture torque test was done in accordance with Osstem standard (Rotational Fracture torque test, OS-C-0012) and result is in compliance with it.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Kl03105
OSSTEM Implant Co., Ltd
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Oct 6, 2010
- Company and Correspondent making the submission:
OSSTEM Implant Co., Ltd. - Submitter's Name : #507-8 Geoje3-Dong Yeonie-Gu - Address : Busan, 611-804, Republic of Korea 82 51 850 2574 - Telephone No. - Contact : Mr. JongHyuk Seo 2. Device :
Orthodontic Screw System Dental implant, endosseous, orthodontic 21CFR872.3640 Class II OAT
3. Predicate Device :
Trade or (Proprietary) Name :
Common or usual name :
Classification Name :
The Super Orthodontic Screw System, OSSTEM Implant Co., Ltd, K062156
-
- Description :
The Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length. It is made of Titanium alloy (Ti-6AI-4V ELI, ASTM F 136- 02A). The surface of the screw is non-treated.
- Description :
1
OSSTEM Implant Co., Ltd. SSTEM®
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
- Substantial Equivalence Matrix
| Orthodontic screw | Predicate devices | |
|---|---|---|
| Super Orthodontic screw | ||
| (K062156) | ||
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| Indication | ||
| For Use | The Orthodontic Screw is | |
| indicated for use as a fixed | ||
| anchorage point for attachment of | ||
| orthodontic appliances to facilitate | ||
| the orthodontic movement of teeth. | ||
| It is used temporarily and is | ||
| removed after orthodontic | ||
| treatment has been completed. | ||
| Screws are intended for single use | ||
| only | The Super Orthodontic Screw is | |
| indicated for use as a fixed | ||
| anchorage point for attachment of | ||
| orthodontic appliances to facilitate | ||
| the orthodontic movement of teeth. | ||
| It is used temporarily and is | ||
| removed after orthodontic | ||
| treatment has been completed. | ||
| Screws are intended for single use | ||
| only | ||
| Structure | Through Hole : Wire hole | |
| Simple Head : No hole | ||
| Tapered body | Slot | |
| Wire hole | ||
| Tapered body | ||
| Diameter (D) | ||
| Length (mm) | Refer to the Table 1 | |
| Material of | ||
| Fixture | Titanium alloy (Ti-6Al-4V ELI) | |
| (ASTM F 136-02A) | Titanium alloy (Ti-6Al-4V ELI) | |
| (ASTM F 136-02A) | ||
| Sterilization | Radiation Sterile | Radiation Sterile |
| Shelf life | 5 years | 5 years |
| S & E | The Orthodontic screw system has same material and indication for use | |
| and similar design and technological characteristics as the predicate | ||
| device. |
| Orthodontic screw | Predicate devices | ||
|---|---|---|---|
| (Ø) | (mm) | Super Orthodontic screw (K062156) (Ø) | (mm) |
| 1.4 | 6.0, 8.0 | - | - |
| 1.6 | 6.0, 8.0, 10.0 | 1.6 | 6.0, 8.0, 10.0 |
| 1.8 | 6.0, 8.0, 10.0 | 1.8 | 6.0, 8.0, 10.0 |
Table 1. Diameter and length (Orthodontic screw and Predicate devices)
- Indication for use :
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only
2
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
6. Review :
The Orthodontic screw system has same material and indication for use and similar design and technological characteristics as the predicate device.
The Orthodontic screw system has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
-
- Summary of nonclinical testing
Fracture load test was done in accordance with Osstem standard (Fracture & Bending test. OS-C-0013) and result is in compliance with it.
- Summary of nonclinical testing
Rotational Fracture torque test was done in accordance with Osstem standard (Rotational Fracture torque test, OS-C-0012) and result is in compliance with it.
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the Orthodontic screw system is safe and effective and substantially equivalent to the predicate device as described herein.
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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which consists of a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OSSTEM Implant, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
MAR 2 5 2011
Re: K103105
Trade/Device Name: Orthodontic Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 23, 2011 Received: February 24, 2011
Dear Mr. Lim:
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.
4
Page 2- Mr. Lim
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Antinom Onis
Anthony D. Watson, B.S., M.S., M.B.A. Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The logo is black and white and features the word "OSSTEM" in a stylized font, with the word "IMPLANT" underneath in a smaller font. There is a small degree symbol to the right of the word "OSSTEM".
SSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Number K 10310S
Device Name: Orthodontic Screw
Indication for use : The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only
Prescription Use X (Per 21CFR801 Subpart D)
Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumer
(Division Sign-Off) (Division Sign-chi) Division Control, Dental Devices
510(k) Number: K163185