Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical orthodontic screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
A therapeutic device is one that treats or cures a disease or condition. This device is used as an anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth, which is a structural or mechanical application rather than a direct therapeutic intervention.

Diagnostic

No

The device description indicates that the Orthodontic Screw is used as a "fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth." It is a treatment device, not one that diagnoses a condition.

SaMD (Software as a Medical Device)

No

The device is a physical orthodontic screw made of titanium alloy, intended for surgical implantation. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, 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, or tissue) to provide information about a person's health.
Device Description: The description clearly states that the Orthodontic Screw is a physical device surgically placed in the bone. It is a mechanical device used to provide anchorage for orthodontic appliances.
Intended Use: The intended use is to facilitate the physical movement of teeth by providing a fixed anchorage point. This is a mechanical function, not a diagnostic test performed on a sample.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information about a patient's condition.

Therefore, the Orthodontic Screw falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 (comma separated list FDA assigned to the subject device)

OAT

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. 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw arches

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professional use only - qualified dentists. Strictly reserved to specialized and trained users.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103105, K060126

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122171, K072896

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 +82 51 850-2500, fax number +82 51 850-4341 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.

'EM Implant Co., Lt

Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

510(k) Summary

Date: December 13, 2016

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:	+82 51 850 2575
- 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

1. 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

1. 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: +82 51 850-2500 Fax: +82 51 850-4341 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
(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
(Through Hole)	Head Features	Head height(2.15mm) and smooth curved head
Wire Can be used up to 022" wire using by hole
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
(Small Head)	Head Features	Min. Head Size(1.48mm) and Head height(1.95mm)
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
(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
(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)

5

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: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

| Orthodontic Screw
(Half Etched-Through Hole) | Head Features | Head height(2.15mm) and smooth curved head
Wire Can be used up to 022" wire using by hole
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
(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
(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
Microimplant	510(K) No.	K161197	K103105	K122171
510(K) No.	K161197	K103105	K060126	Manufacturer	OSSTEM Implant Co.,
Ltd.	OSSTEM Implant Co.,
Ltd.	OSSTEM Implant Co.,
Ltd.
Manufacturer	OSSTEM Implant Co.,
Ltd.	OSSTEM Implant
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
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 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 MS SA Implant
(Narrow Ridge) is
intended to use in the
treatment of missing
mandibular central and
lateral incisors to support
prosthetic device, such as
artificial teeth, in order to
restore chewing function
in partially edentulous
patients. The MS SA
Implant (Narrow Ridge) is
intended for single use
only. It is intended for
delayed loading.
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	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	Provide a fixed
anchorage point for
attachment of
orthodontic appliances to
facilitate the orthodontic
movement of teeth.	Head structure	Simple Head, Through
Hole, Small Head,
Bracket Head	Simple Head, Through
Hole	-
Head structure	completed. Screws are
intended for single use
only	removed after
orthodontic treatment
has been completed.
Screws are intended
for single use only	1.Small head
2.No head
3.Long head
4.Circle head
5.Fixation head
6.Bracket head
7.Bracket head-left
handed screw
8.OMAS
mushroom	Body Diameter (D)	$ Ø $ 1.2mm, $ Ø $ 1.4mm,
$ Ø $ 1.6mm, $ Ø $ 1.8mm	$ Ø $ 1.4mm, $ Ø $ 1.6mm,
$ Ø $ 1.8mm	$ Ø $ 2.5mm, $ Ø $ 2.9mm
Body Diameter
(D)	$Ø$ 1.2mm, $Ø$ 1.4mm,
$Ø$ 1.6mm, $Ø$ 1.8mm	$Ø$ 1.4mm, $Ø$ 1.6mm,
$Ø$ 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-
4V ELI, ASTM F 136	Titanium alloy Ti-6Al-
4V ELI, ASTM F 136	Titanium alloy Ti-6Al-
4V ELI, ASTM F 136
Material of
Fixture	Ti-6Al-4V ELI, ASTM F
136	Ti-6Al-4V ELI,
ASTM F 136	Ti-6Al-4V ELI,
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 ;
Steam Sterilize
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
population	Professional use only -
qualified dentists.
Strictly reserved to
specialized and trained
users.	Professional use only

qualified dentists.
Strictly reserved to
specialized and trained
users. | Professional use only
qualified dentists.
Strictly reserved to
specialized and trained
users. | | | | |
| principles of
operation | Orthodontic screw is
inserted into either jaw to
help the orthodontist
move the correct teeth and
stop the wrong teeth from
moving in the wrong
direction. | Orthodontic screw is
inserted into either jaw
to help the
orthodontist move the
correct teeth and stop
the wrong teeth from
moving in the wrong
direction. | | | | | |
| SE | Orthodontic screw has been predicated by 510(K), K103105 but It is
resubmitted to add $Ø$ 1.2mm Diameter and Small Head, Bracket Head type
orthodontic screw
We conducted performance test due to addition of smaller diameter $Ø$ 1.2mm
Fracture load Test, Rotational fracture torque test, Axial pull-out strength test
We state Orthodontic screw is not different from predicate, the Orthodontic
screw (K103105) and Absoanchor Microimplant (K060126) on the safety
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: +82 51 850-2500 Fax: +82 51 850-4341 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: +82 51 850-2500 Fax: +82 51 850-4341 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 +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com

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

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 +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.

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