Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device, a dental implant system, is used to replace missing teeth and support restorations. While it aids in restoring function, its primary purpose is mechanical support and replacement, not direct treatment or cure of a disease or condition.

Diagnostic

No

The device description indicates it is a 'dental implant system' intended for surgical placement to replace missing teeth, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant system made of physical materials (CP TiGr 4) and includes various hardware components (implants, abutments, screws). The performance studies also focus on physical properties and sterilization, not software validation.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for surgical placement in the bone of the jaw to support dental restorations. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details a dental implant system made of titanium, designed for surgical placement. It does not mention any components or functions related to analyzing biological samples.
Performance Studies: The performance studies focus on sterilization, surface characteristics, fatigue testing, and biocompatibility (cytotoxicity and sensitization). These are typical tests for implantable medical devices, not IVDs.
Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, calibrators, controls, or any other elements associated with in vitro diagnostic testing.

Therefore, the AR N Type Implant System is a dental implant, which is a surgical medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AR N Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR N Type Implant System is for two stage surgical procedures. It is intended for delayed load.

Product codes

DZE, NHA

Device Description

The AR_N Type Implant System is a dental implant system made of CP TiGr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period.

The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with RBM (Resorbable Blast Media). The AR_N Type Implant System is offered in the following sizes.

Platform
Ø 3.7
Ø 4.2
Ø 4.6
Ø 5.1

Body Diameter
Ø 3.5
Ø 4.0
Ø 4.5
Ø 5.0

Total Length (mm)
7.5, 8.5, 10.0, 11.5, 13.0, 15.0

Abutment: Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae, upper or lower jaw arches

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)

Non-Clinical Test data:

Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance with ISO 11137, SIO 11737-1& ISO 11737-2 for gamma sterilization
Steam Sterilization validation for non-sterile devices (abutments) has been performed in accordance with ANSI/AAMI ST79.
Surface Characteristics Test Report Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
Comparative Fatigue testing of the subject device and predicate device has been performed in accordance with ISO 14801:2007.
Cytotoxicity Test performed according to ISO 10993-5:2009
Sensitization test performed according to ISO 10993-10:2010

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s)

CMI IS Implant System (K113554)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

January 31, 2018

Biotem Co., Ltd. c/o Joyce Bang Consultant Provision Consulting Group Inc. 14071 Peyton Dr. #967 Chino Hills, California 91709

Re: K171297

Trade/Device Name: AR N Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2017 Received: January 4, 2018

Dear Joyce Bang:

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 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);

1

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -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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Indications for Use

510(k) Number (if known) K171297

Device Name AR N Type Implant System

Indications for Use (Describe)

AR N Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR N Type Implant System is for two stage surgical procedures. It is intended for delayed load.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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16. 510(K) SUMMARY

Submitter:

Hong Koo Yeo Biotem Co., Ltd. 57, Sasang-ro , 401 beon-gil , Sasang-gu, Busan , Korea Tel : +82-70-8220-4934 Fax : +82-51-908-8257

Official Correspondent/US Agent:

Jovce Bang Provision Consulting Group, Inc. 1370 Valley Vista Suite 200 Phone: +1-909-550-0131 EXT.1131 Date Prepared: January 26, 2018

Device Information:

Device Name: AR_N Type Implant System Classification Name: Endosseous Dental Implant Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640

Predicate devices

• CMI IS Implant System (K113554) manufactured by Neobiotech Implant Co., Ltd.

Indication for use

AR N Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR_N Type Implant System is for two stage surgical procedures. It is intended for delayed loading.

Device Description

The AR_N Type Implant System is a dental implant system made of CP TiGr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period.

The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with RBM (Resorbable Blast Media). The AR_N Type Implant System is offered in the following sizes.

Platform	Body Diameter	Total Length (mm)
Ø 3.7	Ø 3.5	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.2	Ø 4.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.6	Ø 4.5	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 5.1	Ø 5.0	7.5, 8.5, 10.0, 11.5, 13.0, 15.0

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Abutment

Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

Abutments	Connection	Angulation (°)	Sizes
			Cuff Heights (mm)	Platform diameter (Ø)
Angled
abutment	Assembled with Fixture and
Angled Abutment (Hex) by
inserting Abutment body with set
screw. The connection type is
internal Hexagon shape.	15, 25	2, 4	4.5~5.8
Cemented
Abutment
(Hex)	Assembled with fixture and
cemented abutment (Hex) by
inserting abutment body with set
screw. The connection type is
Internal Hexagon shape	0	1~6	4.5~6.5
Cemented
Abutment
(Non-Hex)	Assembled with Fixture and
Cemented Abutment (Non-Hex)
by inserting Abutment body with
set screw. The connection type is
internal Non-Hexagon shape.	0	1~6	4.5~6.5
Healing
Abutment	Assembled with Fixture and
Healing Abutment by inserting the
screw part. And the connection is
internal Hexagon shape	0	1~5	4.5~6.5
Solid
Abutment	Assembled with fixture by
inserting set screws. The
connection type is internal
Hexagon shape.	0	1~6	4.5~6.5
Cover Screw	Assembled with Fixture by
inserting screw part.
And the connection is internal
Hexagon shape.	0	2.7	2.8 -3.3
Set screw	Connection with abutment with
screw	0	10 (length)	2.1, 2.5

Substantial Equivalence Comparison Chart

	Subject Device	Predicate Device
510(k) Number	K171297	K113554
Device Name	AR_N Type Implant System	CMI IS Implant System
Manufacturer	Biotem Co., Ltd.	Neobiotech Co., Ltd.

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| | | Principles of Operation | Subject device is an endosseous
implants and are integrated in the
bone (osseointegration). They are
intended to be used for surgical
placement in the upper or lower jaw
to provide a means for prosthetic
attachment for anchoring or
supporting tooth replacements to
restore chewing function. | Predicate device is an endosseous
implants and are integrated in the
bone (osseointegration). They are
intended to be used for surgical
placement in the upper or lower jaw
to provide a means for prosthetic
attachment for anchoring or
supporting tooth replacements to
restore chewing function. |
|---------------------|--------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | | | AR_N Type Implant System is
indicated for use in partially or fully
edentulous mandibles and maxillae,
in support of single or multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework. AR_N
Type Implant System is for two stage
surgical procedures. It is intended for
delayed load. | The CMI Implant IS System is
indicated for use in partially or fully
edentulous mandibles and maxillae, in
support of single or multiple-unit
restorations including; cemented
retained, screw retained, or
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework. IS
System is dedicated for two stage
surgical procedures and for
immediate loading when there is
good primary stability and an
appropriate occlusal load. Also,
implants with diameters larger than 5
min are indicated for molar regions. |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | Design | Internal Hex Submerged
Macro thread | Internal Hex Submerged
Macro thread |
| | | Material | CP Ti Gr 4
ASTM F67 | CP Ti Gr 4
ASTM F67 |
| | | Fixture Sterilization | Gamma sterilization | Gamma sterilization |
| | | Fixture Diameter (mm) | Ø3.7 - 5.1 | Ø3.5 - 8.0 |
| | | Fixture Length (mm) | 7.5 - 15.0 | 7.0 - 15.0 |
| | | Surface treatment | RBM | RBM |
| | | Diameters | Ø4.5 - 6.5mm | Ø3.5 - 6.5 |
| | | Lengths | 4.0 - 9.0mm | 4.0-9.0mm |
| Abutment | Angled | | 15°, 25° | 15°,25° |
| Abutment material | | | CP Ti Gr 4
ASTM F67 | CP Ti Gr 4
ASTM F67 |
| | | | | |
| | | Abutment sterilization | Non-sterile | Non-sterile |
| Product Code | | | DZE, NHA | DZE, NHA |

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| | Subject abutments
Biotem Product (AR N type) | | | Predicate abutments
NEO BIOTECH Product (IS-II type) | | |
|-----------------------------------|-------------------------------------------------|----------------------|----------------|---------------------------------------------------------|----------------------|----------------|
| | Platform
diameter (Ø) | Cuff heights
(mm) | Angulation (°) | Platform
diameter (Ø) | Cuff heights
(mm) | Angulation (°) |
| Healing
abutment | 4.5~~6.5 | 1~~5 | 0 | 4.0~~6.0 | 2~~7 | 0 |
| Cemented
abutment
(hex) | 4.5~~6.5 | 1~~6 | 0 | 4.5~~6.5 | 1~~4 | 0 |
| Cemented
abutment
(non-hex) | 4.5~~6.5 | 1~~6 | 0 | 4.5~~6.5 | 1~~4 | 0 |
| Solid
abutment | 4.5~~6.5 | 1~~6 | 00 | 4.5~~6.5 | 1~~7 | 0 |
| Angled
abutment | 4.5~~5.8 | 2,4 | 15, 25 | 4.5~~5.7 | 2,3,4 | 15, 25 |

Basis for Substantial Equivalence

The AR N Type Implant System has a substantially equivalent intended use as the identified predicate. Both are used for mandible and maxilla endosseous dental implant and accessories. The AR N Type Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments. They all share same internal hexagon submerged connection system. The subject and predicate devices are both bone-level implants that share same tapered body design and cutting edge. The subject and predicate devices are similar in size, same surface treatment and materials.

Non-Clinical Test data

The subject device was tested to evaluate its performance as below.

Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance with ISO 11137, SIO 11737-1& ISO 11737-2 for gamma sterilization
Steam Sterilization validation for non-sterile devices (abutments) has been performed in accordance with ANSI/AAMI ST79.
Surface Characteristics Test Report Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
Comparative Fatigue testing of the subject device and predicate device has been performed in accordance with ISO 14801:2007.
Cytotoxicity Test performed according to ISO 10993-5:2009
· Sensitization test performed according to ISO 10993-10:2010

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusions

Overall, the AR N Type Implant System has the following similarities to the predicate devices:

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*has the same intended use,

*uses the same operating principle,

*incorporates the same basic design,

*incorporates the same material and the surface treatment.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, we conclude that the AR_N Type Implant System is substantially equivalent to the predicate device.