Orthodontic Screw

K161197 · Osstem Implant Co., Ltd. · OAT · Dec 21, 2016 · Dental

Device Facts

• Record ID: K161197
• Device Name: Orthodontic Screw
• Applicant: Osstem Implant Co., Ltd.
• Product Code: OAT · Dental
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Orthodontic screw is a titanium alloy (Ti-6Al-4V ELI) dental device; surgically placed into upper or lower jaw bone by qualified dentists; serves as temporary fixed anchorage point for orthodontic appliances (wires, springs, elastic ligatures) to facilitate tooth movement; removed upon treatment completion. Available in diameters 1.2-1.8mm and lengths 6-10mm; features various head designs (simple, through-hole, small, bracket) and surface treatments (machined or acid-etched). Device provides mechanical support to guide tooth positioning and prevent unwanted movement.

Clinical Evidence

No clinical studies submitted. Bench testing only: fracture load test, rotational fracture torque test, and axial pull-out strength test performed to validate performance of new 1.2mm diameter screws.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F 136. Dimensions: 1.2-1.8mm diameter, 6-10mm length. Surface: Machined or acid-etched. Sterilization: Radiation sterile.

Indications for Use

Indicated for patients requiring orthodontic tooth movement; used as a fixed anchorage point for orthodontic appliances. Contraindications not specified.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Orthodontic screw, Osstem implant co.,Ltd (K103105)

Reference Devices

• MS SA Implant System, Osstem implant co.,Ltd (K122171)
• Absoanchor Microimplant, Dentos Inc (K060126)
• K072896 (Gamma irradiation process)

Submission Summary (Full Text)

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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2016

Osstem Implant Co., Ltd. % David Kim Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills. Pennsylvania 19030

Re: K161197

Trade/Device Name: Orthodontic Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: November 23, 2016 Received: November 23, 2016

Dear David Kim:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name and the word "IMPLANT" in orange. The contact information includes the company's address at 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as their telephone number [phone], fax number [phone] and website www.osstem.com.

# Indications for Use Statement

### Indications for Use

510(k) Number : K161197

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) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

QS-QI-505-2(Rev.0)

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Image /page/3/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. The logo is simple and modern.

2.

'EM Implant Co., Lt

Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

## 510(k) Summary

Date: December 13, 2016

1. Company and Correspondent making the submission:

| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|-------------------------|----------------------------------------------|
| - Address : | 66-16, Bansong-ro 513beon-gil, Haeundae-gu |
| | Busan, Republic of Korea |
| - Contact : | Mr. Hee Kwon Son |
| - Phone: | [phone] |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
| - Device : | |

| Trade or (Proprietary) Name : | Orthodontic Screw |
|-------------------------------|----------------------------------|
| Device Name : | Implant, Endosseous, Orthodontic |
| Regulation Name : | Endosseous Dental Implant |
| Regulation Number : | 21 CFR 872.3640 |
| Device Classification: | Class II |
| Product Code: | OAT |

- 3. Predicate Device :
Primary Predicate K103105, Orthodontic screw, Osstem implant co.,Ltd

Reference predicate K122171, MS SA Implant System, Osstem implant co.,Ltd K060126, Absoanchor Microimplant, Dentos Inc

- 4. Device Description :
This product is orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment.

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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in two lines, with the word "OSSTEM" in orange on the top line. The word "IMPLANT" is in gray on the bottom line. The logo is simple and modern.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily and is removed after orthodontic treatment has been completed.

Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures.

The Orthodontic Screw is a dental device made of titanium alloy metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.

It is 1.2, 1.4, 1.6 and 1.8mm in screw diameter and 6, 8, 10mm in length.

It is made of Titanium alloy (Ti-6Al-4V ELI).

There are two types of surface treatment one is non-treated (Machineed) another one is Acid etching

| Product Name | | Content |
|------------------------------------------------|---------------|----------------------------------------------------------------------------------------------------------------------|
| Orthodontic Screw<br>(Simple Head) | Head Features | Low head height(1.95mm) and smooth curved head |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.2, 1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Machined (Not acid etched) |
| Orthodontic Screw<br>(Through Hole) | Head Features | Head height(2.15mm) and smooth curved head<br>Wire Can be used up to 022" wire using by hole<br>Hole diameter : Ø0.8 |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.2, 1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Machined (Not acid etched) |
| Orthodontic Screw<br>(Small Head) | Head Features | Min. Head Size(1.48mm) and Head height(1.95mm)<br>smooth curved head |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Machined (Not acid etched) |
| Orthodontic Screw<br>(Bracket Head) | Head Features | Wire compatibility through cross-shaped slot |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Machined (Not acid etched) |
| Orthodontic Screw<br>(Half Etched-Simple Head) | Head Features | Low head height(1.95mm) and smooth curved head |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.2, 1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Acid etching |

QS-QI-505-3(Rev.0)

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Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray and is located below the word "OSSTEM". There is a small orange circle above and to the right of the word "OSSTEM".

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

| Orthodontic Screw<br>(Half Etched-Through Hole) | Head Features | Head height(2.15mm) and smooth curved head<br>Wire Can be used up to 022" wire using by hole<br>Hole diameter : Ø0.8 |
|-------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.2, 1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Acid etching |
| | Orthodontic Screw<br>(Half Etched-Small Head) | Head Features |
| | | Material |
| Diameter (mm) | Ø1.4, 1.6, 1.8 | |
| Length (mm) | 6, 8, 10 | |
| Surface | Acid etching | |
| Orthodontic Screw<br>(Half Etched-Bracket Head) | Head Features | Wire compatibility through cross-shaped slot |
| | Material | Titanium alloy, Ti-6Al-4V ELI |
| | Diameter (mm) | Ø1.4, 1.6, 1.8 |
| | Length (mm) | 6, 8, 10 |
| | Surface | Acid etching |

#### - Substantial Equivalence Matrix

The Orthodontic screw system has same material and indication for use and similar design and technological characteristics as the predicate device.

| | Orthodontic screw | Primary Predicate | Reference predicate | | Orthodontic screw | Orthodontic screw | MS SA Implant System |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Orthodontic screw | Absoanchor<br>Microimplant | 510(K) No. | K161197 | K103105 | K122171 |
| 510(K) No. | K161197 | K103105 | K060126 | Manufacturer | OSSTEM Implant Co.,<br>Ltd. | OSSTEM Implant Co.,<br>Ltd. | OSSTEM Implant Co.,<br>Ltd. |
| Manufacturer | OSSTEM Implant Co.,<br>Ltd. | OSSTEM Implant<br>Co., Ltd. | Dentos Inc | Design | Image: Orthodontic screw design | Image: Orthodontic screw design | Image: MS SA Implant System design |
| Design | Image: Orthodontic screws | Image: Orthodontic screws | Image: Absoanchor Microimplant | Intended use | The Orthodontic Screw is<br>indicated for use as a<br>fixed anchorage point for<br>attachment of orthodontic<br>appliances to facilitate the<br>orthodontic movement of<br>teeth. It is used<br>temporarily and is<br>removed after orthodontic<br>treatment has been<br>completed. Screws are<br>intended for single use<br>only | The Orthodontic Screw is<br>indicated for use as a<br>fixed anchorage point for<br>attachment of orthodontic<br>appliances to facilitate the<br>orthodontic movement of<br>teeth. It is used<br>temporarily and is<br>removed after orthodontic<br>treatment has been<br>completed. Screws are<br>intended for single use<br>only | The MS SA Implant<br>(Narrow Ridge) is<br>intended to use in the<br>treatment of missing<br>mandibular central and<br>lateral incisors to support<br>prosthetic device, such as<br>artificial teeth, in order to<br>restore chewing function<br>in partially edentulous<br>patients. The MS SA<br>Implant (Narrow Ridge) is<br>intended for single use<br>only. It is intended for<br>delayed loading. |
| Intended use | The Orthodontic Screw is<br>indicated for use as a fixed<br>anchorage point for<br>attachment of orthodontic<br>appliances to facilitate the<br>orthodontic movement of<br>teeth. It is used<br>temporarily and is<br>removed after orthodontic<br>treatment has been | The Orthodontic<br>Screw is indicated for<br>use as a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances<br>to facilitate the<br>orthodontic movement<br>of teeth. It is used<br>temporarily and is | Provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances to<br>facilitate the orthodontic<br>movement of teeth. | Head structure | Simple Head, Through<br>Hole, Small Head,<br>Bracket Head | Simple Head, Through<br>Hole | - |
| Head structure | completed. Screws are<br>intended for single use<br>only | removed after<br>orthodontic treatment<br>has been completed.<br>Screws are intended<br>for single use only | 1.Small head<br>2.No head<br>3.Long head<br>4.Circle head<br>5.Fixation head<br>6.Bracket head<br>7.Bracket head-left<br>handed screw<br>8.OMAS<br>mushroom | Body Diameter (D) | $ Ø $ 1.2mm, $ Ø $ 1.4mm,<br>$ Ø $ 1.6mm, $ Ø $ 1.8mm | $ Ø $ 1.4mm, $ Ø $ 1.6mm,<br>$ Ø $ 1.8mm | $ Ø $ 2.5mm, $ Ø $ 2.9mm |
| Body Diameter<br>(D) | $Ø$ 1.2mm, $Ø$ 1.4mm,<br>$Ø$ 1.6mm, $Ø$ 1.8mm | $Ø$ 1.4mm, $Ø$ 1.6mm,<br>$Ø$ 1.8mm | $Ø$ 1.2mm - $Ø$ 1.8mm | Length (mm) | 6mm, 8mm, 10mm | 6mm, 8mm, 10mm | 8.5, 10.0, 11.5, 13.0mm |
| Length (mm) | 6mm, 8mm, 10mm | 6mm, 8mm, 10mm | 4mm -10mm & 12mm | Material of Fixture | Titanium alloy Ti-6Al-<br>4V ELI, ASTM F 136 | Titanium alloy Ti-6Al-<br>4V ELI, ASTM F 136 | Titanium alloy Ti-6Al-<br>4V ELI, ASTM F 136 |
| Material of<br>Fixture | Ti-6Al-4V ELI, ASTM F<br>136 | Ti-6Al-4V ELI,<br>ASTM F 136 | Ti-6Al-4V ELI,<br>ASTM F 136 | Surface | Acid etching | Machined | SA $(Sandblasting and Acidetching)$ . |
| Surface | Machined | Machined | - | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Sterilization | Radiation Sterile | Radiation Sterile | Non-Sterile ;<br>Steam Sterilize<br>before use | Shelf life | 8 years | 5 years | 8 years |
| Shelf life | 8 years | 5 years | - | Target | Professional use only - | Professional use only - | Professional use only - |
| Target<br>population | Professional use only -<br>qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. | Professional use only<br>- qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. | Professional use only<br>- qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. | | | | |
| principles of<br>operation | Orthodontic screw is<br>inserted into either jaw to<br>help the orthodontist<br>move the correct teeth and<br>stop the wrong teeth from<br>moving in the wrong<br>direction. | Orthodontic screw is<br>inserted into either jaw<br>to help the<br>orthodontist move the<br>correct teeth and stop<br>the wrong teeth from<br>moving in the wrong<br>direction. | | | | | |
| SE | Orthodontic screw has been predicated by 510(K), K103105 but It is<br>resubmitted to add $Ø$ 1.2mm Diameter and Small Head, Bracket Head type<br>orthodontic screw<br>We conducted performance test due to addition of smaller diameter $Ø$ 1.2mm<br>Fracture load Test, Rotational fracture torque test, Axial pull-out strength test<br>We state Orthodontic screw is not different from predicate, the Orthodontic<br>screw (K103105) and Absoanchor Microimplant (K060126) on the safety<br>and effectiveness. | | | | | | |

QS-QI-505-3(Rev.0)

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Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, thinner font. There is a registered trademark symbol next to the word "OSSTEM".

**OSSTEM Implant Co., Ltd.**

OSSTEM Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeunda-gu, Busan, Republic of Korea
Tel: [phone] Fax: [phone] www.osstem.com

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Image /page/7/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small orange circle in the upper right corner of the logo.

OSSTEM Implant Co., Ltd.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: [phone] Fax: [phone] www.osstem.com

> Because Orthodontic screw has the same principles of operation, material, indication for use and similar design (Diameter and length are also included in dimension range of predicate) as the predicate

QS-QI-505-3(Rev.0)

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Image /page/8/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.

## EM Implant Co., Lt

aeundae-on Busan Republic of [phone] Fax: [phone] www.osstem.com

| population | qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. | qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. | qualified dentists.<br>Strictly reserved to<br>specialized and trained<br>users. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| principles of<br>operation | Orthodontic screw is<br>inserted into either jaw<br>to help the orthodontist<br>move the correct teeth<br>and stop the wrong<br>teeth from moving in<br>the wrong direction. | Orthodontic screw is<br>inserted into either jaw<br>to help the orthodontist<br>move the correct teeth<br>and stop the wrong<br>teeth from moving in<br>the wrong direction. | |
| S E | Orthodontic screw has been predicated by 510(K), K103105 but It is<br>resubmitted to add Ø1.2mm Diameter, and Small Head, Bracket Head type<br>orthodontic screw and change surface that is Acid etching<br>We conducted performance test due to addition of smaller diameter Ø1.2mm.<br>Surface treatment of Orthodontic screw is same with MS SA Implant System<br>except Sand Blasting process of MS SA Fixture, Therefore we certify that<br>Orthodontic Screw is same with MS SA Fixture from a Biocompatibility<br>point of view<br>We state Orthodontic screw is not different from predicate, the Orthodontic<br>screw (K103105) and Absoanchor Microimplant (K060126) on the safety<br>and effectiveness.<br>Because Orthodontic screw has the same principles of operation, material,<br>indication for use and similar design (Diameter and length are also included<br>in dimension range of predicate) as the predicate | | |

#### 5. 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

#### 6. Summary of nonclinical testing

The Orthodontic screw system has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable International and US regulations.

Performance Testing of Orthodontic screw is conducted

- Fracture load Test
- Rotational fracture torque test
- Axial pull-out strength test

Biocompatibility for the Orthodontic screw is demonstrated by the reference to K122171. Validation of the gamma irradiation process is demonstrated by the reference to K072896. Surface treatment characterization testing is demonstrated by the reference to K122171.

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Image /page/9/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The telephone number is [phone], the fax number is [phone], and the website is www.osstem.com.

- 7. Summary of clinical testing No clinical studies are submitted
- 8. 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 Osstem Implant Co., Ltd. concludes that the Orthodontic screw is substantially equivalent to the predicate devices as described herein.