ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4 - 1.8 mm in diameter and range from 5-13 mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the ORLUS mini screw, a dental device. It declares substantial equivalence to a predicate device and outlines the device's characteristics and intended use.

However, the document does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria. It is a regulatory submission for premarket notification, not a clinical or performance study report.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set, data provenance, or details on training sets.
Information on experts, ground truth establishment, or adjudication methods for any test data.
Details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

The document states, "ORLUS mini screw has been subjected to product validations prior to release," but it does not provide any specifics of these validations, their methodologies, or their results in relation to performance criteria.

Therefore,Based on the provided text, I cannot describe the acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary and does not contain the detailed performance study information requested.

Summary

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Ortholution Co.,Ltd.

Ko 52968

SEP - 8 2006

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 26, 2005

Company making the submission:

	Company
Name	Ortholution Co., Ltd.
Address	207 Dunchon B/D., #416-1 Seongnae-Dong,Gangdong-Gu, Seoul, Korea
Phone
Fax	+ 82 2-483-1212
Contact	+ 82 2-478-0735
Internet	J. M. Kim / presidentDoldol22@netian.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

1. Classifications Names & Citations:
  114

21CFR 872.3640, DZE, Endosseous dental implant, Class2

1. Description:
  ORLUS mini screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is 1.4 - 1.8 mm in diameter and range from 5-13 mm in total length and is made of Titanium 6Al-4V alloy. There are dual heads in the screw with which a wire can be hung to fix the maxilla and mandible. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

000018

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Ortholution Co.,Ltd.

1. Indication for use:
  The ORLUS mini screw is intended for use as temporary anchor for orthodontic treatment.
1. Contra-indications:
- 1. Osteoporosis
- 1. Advanced diabetes
- 1. Metal allergies

8. Review:

ORLUS mini screw has the same device characteristics, material, design and intended use as the predicate device.

ORLUS mini screw has been subjected to product validations prior to release.

Appropriate safeguards have been incorporated in the design of ORLUS mini screw.

1. 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded helix intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 8 2006

Ortholution Company, Limited C/O Ms. Cathryn N. Cambria Consultant Arkin Consulting Group, LLC 5536 Trowbridge Drive Atlanta, Georgia 30338

Re: K052968

Trade/Device Name: ORLUS Mini Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 24, 2006 Received: August 30, 2006

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 cither 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.

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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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Indications for Use

510(k) Number (if known): Ko 52968

Device Name: ORLUS Mini Screw

ﺎ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

Indications for Use: The ORLUS Mini Screw is intended for use as a temporary anchor for 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Sign-Off)	Page 1 of 1
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
(510(k)) Number:	1052968

Regulation Number and Section

§ 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.