(60 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is described as an "anchor for orthodontic treatment," which falls under the category of treating and preventing oral health issues.
No
The device, ORLUS Mini Screw, is described as a temporary anchor for orthodontic treatment to provide fixed anchorage for tooth movement, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical screw made of Titanium alloy, intended for temporary anchorage 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 information is used for diagnosis, monitoring, or screening.
- ORLUS Mini Screw Function: The ORLUS Mini Screw is a physical implant used to provide temporary anchorage for orthodontic treatment. It is a mechanical device that directly interacts with the patient's bone and teeth. It does not analyze biological specimens.
The description clearly states its purpose is to provide a "fixed anchorage for orthodontic movement of teeth" and is "used temporarily and removed after orthodontic treatment." This is a therapeutic and mechanical function, not a diagnostic one based on analyzing biological samples.
N/A
Intended Use / Indications for Use
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
Product codes
DZE
Device Description
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.41.8mm in diameter and ranges from 513mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
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)
Not Found
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
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: September 24, 2008
NOV 2 5 2008
-
- Company making the submission:
| Company | |
|---|---|
| Name | Ortholution Co., Ltd. |
| Address | #104 Suntechcity B/D 513-15 |
| Sangdaewon-dong, Joongwon-gu, Kyunggi- | |
| do, KOREA, REPUBLIC OF 462-120 | |
| Phone | +82 31 777-2245 |
| Fax | +82 31 777-2244 |
| Contact | Mr. Choi, Kwang Sun |
| Internet | orlus@ortholution.com |
2. Device
- . Proprietary Name - ORLUS mini screw
- Common Name - Small bone screw
- Classification Name - Endosseous dental implant
3. Predicate Device
- Ortholution Co., Ltd./ ORLUS Mini Screw/ K050568 and K052968 ●
- Jeil Medical Corporation/ Dual Top Anchor System Screws/ K033767 .
-
- Classifications names & Citations:
21 CFR 872.3640, DZE, Endosseous dental implant, Class2
-
- Description:
ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.41.8mm in diameter and ranges from 513mm in total length. It is made of Titanium 6Al-4V alloy. There is a hole in the screw head with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.
- Description:
1
2.07
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- Indication for use:
The ORLUS Mini Screw is intended for use as temporary anchor for orthodontic treatment.
- Indication for use:
-
- Contra-indications:
- Osteoporosis .
- Advanced diabetes o
- e Metal allergies
-
- Review:
ORLUS Mini Screw has the same device characteristics, material, design and intended use as the predicate device.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Ortholution Co., Ltd. Concludes that ORLUS Mini Screw is safe and effective and substantially equivalent to the predicate device as described herein.
- Conclusions:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized eagle emblem, with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ortholution Company, Limited C/O Ms. Cathryn N. Cambria Arkin Consulting Group, LLC 5536 Trowbridge Drive Dunwoody, Georgia 30338
NOV 2 5 2008
Re: K082838
Trade/Device Name: ORLUS Mini Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 5, 2008 Received: November 7, 2008
Dear Ms. Cambria:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Cambria
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Surite Y. Micham Omd
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known)
Device Name ORLUS mini screw
Indications for Use
The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
Prescription Use
(Per 21 CFR 801. Subpart D)
OR
Over-The-Counter Use (21CFR801 Subpart C)
1
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
fursn
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: