IT-III active System

• K Number: K181137
• Device Name: IT-III active System
• Manufacturer: Neobiotech Co., Ltd.
• Date Cleared: 2018-11-16 ( 200 days)
• Product Code: DZE NHA
• Regulation Number: 872.3640

Intended Use

The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

Predicate Devices

K090527

Reference Devices

K052957, K070228, K112045, K120503, K121585, K160828, K181138

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and its components, focusing on materials, mechanical properties, and surgical procedures. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.

Therapeutic

No.

The device replaces missing tooth function and supports restorations, rather than directly treating a disease or condition.

Diagnostic

No

The device description clearly states its purpose is to replace missing teeth and support dental restorations, which are therapeutic and restorative functions, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system is composed of "Fixture and Abutments," which are physical components made of titanium and other materials, designed to be implanted into bone. The performance studies also detail testing related to the physical properties and sterilization of these hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use clearly describes a device used in the body (mandibles and maxillae) to support dental restorations. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
• Device Description: The description details a dental implant system made of titanium, designed to be placed in bone. This is a surgical implant, not a diagnostic tool.
• Performance Studies: The performance studies focus on mechanical properties (fatigue), sterilization, shelf life, bacterial endotoxin, and biocompatibility. These are relevant to an implantable device, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory tests.

Therefore, this device falls under the category of a medical device, specifically a dental implant system, and not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa.

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).

The IT -III active System Abutment are composed as below;
IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw

The IT-III active Fixture, IT Cover Screw and IT Healing Abutment are provided sterilized. And the other Abutments are provided non-sterilized.

IT-III active Fixture is enclosed with cover screw in a packing. Other Abutments are enclosed with abutment screw in a packing. The Solid Abutment and Excellent Solid Abutment are enclosed with Protective cap.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxillae

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 testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.

• Fatigue Testing according to ISO 14801:2016 under the worst-case scenario
• Sterilization Testing according to ISO 11137-1:2006. ISO 11137-2:2013, and ISO 11137-3:2006
• Shelf Life Testing according to ASTM F1980
• Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP
• Biocompatibility Evaluation according to ISO 10993-1:2009

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Biocompatibility Test conducted on our own predicate device, K181138 was leveraged for the subject device, and it demonstrates that the subject device is biocompatible.

Fatigue testing for IT-III active fixture and angled Abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario to ensure that the subject device is strong enough for its intended use.

End user sterilization Validation performed on our own predicate device, K181138 was leveraged for the subject device.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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.

K090527

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.

K052957, K070228, K112045, K120503, K121585, K160828, K181138

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

November 16, 2018

Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K181137

Trade/Device Name: IT-III active System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 11, 2018 Received: October 17, 2018

Dear April Lee:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Tina Kiang, Ph.D. for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181137

Device Name IT-III active System

Indications for Use (Describe)

The IT-III active 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 internediate Abutment support for fixed bridgework. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Submitter

Neobiotech Co.. Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu. Seoul 08381 South Korea Email: [e-mail] Tel. [phone] Fax. [phone]

Device Information

• Trade Name: IT-III active System ●
• Common Name: Endosseous Dental Implant
• Classification Name: Implant, Endosseous, Root-Form ●
• Primary Product Code: DZE
• Secondary Product Code: NHA
• Panel: Dental
• Regulation Number: 21 CFR 872.3640
• Device Class: Class II
• Date Prepared: 11/16/2018 ●

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate

• K090527, Sinus Quick TM IT System manufactured by Neobiotech Co., Ltd. .
  Reference Devices

• K052957, Implantium Prosthetics manufactured by Dentium Co., Ltd.

• K070228, Implantium Prosthetics manufactured by Dentium Co., Ltd.

• K112045, Simple Line II Abutment system manufactured by Dentium Co., Ltd.

• K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd. ●

• K121585, TS Implant System manufactured by Osstem Implant Co., Ltd. ●

• K160828, Implantium® / SuperLine® Prosthetics manufactured by Dentium Co., Ltd. ●

• K181138, IS-III active System manufactured by Neobiotech Co., Ltd. ●

Indication for Use:

The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

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Device Description

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa.,

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The dimensions are as following:

Name	Diameter (mm)	G.Collar	Length (mm)
IT-III active Fixture	Ø 3.5	1.8	8.5/10.0/11.5/13.0/15.0
		2.8
	Ø 4.0/4.5/5.0/5.5	1.8	7.0/8.5/10.0/11.5/13.0/15.0
		2.8
	Ø 6.0/7.0	1.8	7.0/8.5/10.0/11.5/13.0
		2.8

Tolerance of dimension shall be within ± 1% range.

The IT -III active System Abutment are composed as below;

IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment,

IT Cemented Abutment Screw and IT Angled Abutment Screw

The dimensions of abutments are as following:

Name	Diameter (mm)	Length of Cuff (mm)
IS Cover Screw	Ø 5.5/6.9	6.0
	Ø 5.8	Cuff: 2.5/3.5/4.5/5.5/6.5
IT Healing Abutment	Ø 6.3/7.1	Cuff: 1.5/2.5/3.5/4.5/5.5/6.5
	Ø 7.2	Cuff: 1.5/2.5/3.5
IT Solid Abutment	Ø 3.5/4.3	4.0/5.5/7.0
IT Excellent Solid Abutment	Ø 4.35	5.25/6.75
	Ø 5.45	5.45/6.0/6.95/7.5/8.45/9.0
Protective cap	Ø 7.2	6.0/7.5/9.0
	Ø 4.3	6.0
	Ø 4.85	5.8
IT Cemented Abutment	Ø 5.5	6.0
	Ø 6.55	5.8
	Ø 3.7	9.5
IT Pre Angled Abutment	Ø 4.3	9.68
IT Collared Angled Abutment	Ø 5.5	7.0
IT Gold UCLA Abutment	Ø 5.5	10.0
IT Cemented Abutment Screw	Ø 2.55	7.55
IT Angled Abutment Screw	Ø 2.55	6.75

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The Abutments have below features:

Name	Uses	Surface	Connection
IT Cover Screw	It is used for protecting inner hole and
connecting part with exposed upper part of
structure during the healing period after
inserting dental implant fixture	N/A
IT Healing
Abutment	Used to formation appropriate gingival
shape during the soft tissue healing period
combined with implant	N/A	Screw
retained
IT Solid Abutment		Anodizing
(Blue/yellow)
Non-Anodizing,
IT Excellent Solid
Abutment		Non-Anodizing,
IT Cemented
Abutment	The Abutment is connected with fixture and
it supports prosthesis which restores tooth
function.	TiN-Coating	Internal
Octa,
Non-Octa,
SCRP
IT Pre Angled
Abutment		N/A
IT Collared Angled
Abutment		TiN-Coating	Internal,
Octa,
Non-Octa
IT Gold UCLA
Abutment		N/A
Protective Cap	Used to protect Solid Abutments in the oral
cavity.	N/A	-
IT Cemented
Abutment screw	It is used to fix Abutment at the top of
fixture.	N/A
IT Angled
Abutment Screw		N/A	Screw retained

Tolerance of dimension for Abutments shall be within ± 1% range.

The surface of IT Cemented Abutment and IT Collared Angled Abutment was treated with TiN-Coated. IT-III active Fixture, IT Cover Screw and IT Healing Abutment are provided sterilized.

And the other Abutments are provided non-sterilized.

IT-III active Fixture is enclosed with cover screw in a packing. Other Abutments are enclosed with abutment screw in a packing. The Solid Abutment and Excellent Solid Abutment are enclosed with Protective cap.

Enclosed package as a set is following:

Product Name	Enclosed product
IT-III active Fixture	IT Cover Screw
IT Solid Abutment	Protective Cap
IT Excellent Solid Abutment	Protective Cap
IT Cemented Abutment	IT Cemented Abutment Screw
IT Pre Angled Abutment	IT Angled Abutment Screw
IT Collared Angled Abutment	IT Cemented Abutment Screw
IT Gold UCLA Abutment	IT Cemented Abutment Screw
IT Healing Abutment	N/A

All of above products including enclosed product are packed separately for convenience.

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Materials:

• The fixture is fabricated from Pure titanium of ASTM F67 ●
• . The Abutments (IT Cover Screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Cemented Abutment Screw, IT Angled Abutment Screw) are fabricated from Ti-6A1-4V ELI of ASTM F136.
• The IT Gold UCLA Abutment is fabricated from Gold Alloy and Polyoxymethylene(POM) of ASTM . F1855.
• . The Protective Cap is fabricated from Polyoxymethylene(POM) of ASTM F1855.

Summaries of Technology Characteristics:

	Subject Device	Primary Predicate	Reference Devices
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Neobiotech Co., Ltd.
Device Name	IT-III active System	Sinus Quick TM IT System	CMI Implant IS II active
510(k) Number	K181137	K090527	K120503
Device
Classification
Name	Implant, Endosseous,
Root-Form	Implant, Endosseous,
Root-Form	Implant, Endosseous,
Root-Form
Product Code	DZE	DZE	DZE
Regulation	872.3640	872.3640	872.3640
Indications for
Use	The IT-III active 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. IT-III
active system is dedicated for
two stage surgical procedures
and for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading.	The Sinus Quick™ IT 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. IT System
is dedicated for two stage
surgical procedures and for
immediate loading	The CMI Implant IS II active
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, and to
restore the patient's chewing
function. It is intended for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.
Material	Pure Titanium of ASTM F67	Pure Titanium of ASTM F67	Pure Titanium of ASTM F67
Design	Image: IT-III active system design	Image: Sinus Quick IT System design	Image: CMI Implant IS II active design
Anti-Rotational
Feature	Internal Octa	Internal Octa	Internal Hex

1) IT-III active Fixture

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Diameters(Ø)	3.5/4.0/4.5/5.0/5.5/6.0/7.0	3.5/4.0/5.0	3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0
Lengths(mm)	7.0/8.5/10.0/11.5/13.0/15.0	8.5/10.0/11.5/13.0/15.0	7.3/8.5/10.0/11.5/13.0/15.0
Surface
Treatment	SLA	RBM	SLA
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Principle of
Operation	This product is a root-type
fixture which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.	This product is a root-type
fixture which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.	This product is a root-type
fixture which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.
Shelf Life	5 Years	5 Years	5 Years
Similarities	The IT-III active Fixture has same device characteristics with the Primary predicate devices, Sinus
Quick TM IT System (K090527) such as diameters, Length, intended use, material, function,
general shape (Design), structure and applied production method are similar.
Differences	The differences between the subject device and the primary predicate device are surface treatment
and upper part design. The surface treatment method of the subject fixture is SLA (Sandblasted
with Large-grit and Acid-etching) and the surface treatment method of the primary Predicate
device is RBM (Resorbable Blasting Media). To support this discrepancy, K120503 was added as
reference predicate which was treated with SLA method.
There is no micro groove in the neck of subject device, but primary predicate has it, and there is a
0.1 mm difference in screw pitch between 0.9 and 0.8. These differences do not raise any question
of substantial equivalence to the declared predicates.

2) IT Cover Screw

	Subject Device	Primary Predicate	Primary Predicate
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Osstem Implant Co., Ltd.
Device
Name	IT-III active System	Sinus Quick TM IT System	TS Implant System
510(k)
Number	K181137	K090527	K121585
Indications
for Use	The IT-III active 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. IT-III
active system is dedicated for
two stage surgical procedures
and for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading.	The Sinus Quick™ IT 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. IT
System is dedicated for two
stage surgical procedures and
for immediate loading	The TS 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 final or temporary
abutment support for
fixed bridgework. It is
intended for delayed
loading. The abutment is
intended for use with
a dental implant fixture to
provide support for
prosthetic restorations such
as crowns,
bridges, or overdenture.

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| | | | TS Implant System is
compatible with abutment in
the ET/SS Implant System |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM
F136 |
| Design | Image: screw | Image: screws | Image: screw |
| Diameters(Ø) | 5.5/6.9 | 3.5/5.5/6.0 | 4.0/4.5/5.0/6.0/7.0 |
| Lengths(mm) | 6.0 | 6.0 | - |
| Surface
Treatment | N/A | N/A | Anodizing |
| Sterilization | Gamma Sterilization | Gamma Sterilization | - |
| Principle of
Operation | Cover screw as a set of medical
devices is used for protecting
inner hole and connecting part
with exposed upper part of
structure during the healing
period after inserting dental
implant fixture. When inserting
the Abutment,
Cover screw is removed. | Cover screw as a set of medical
devices is used for protecting
inner hole and connecting part
with exposed upper part of
structure during the healing
period after inserting dental
implant fixture. When inserting
the Abutment, Cover screw is
removed. | Cover screw as a set of
medical devices is used for
protecting inner hole and
connecting part with
exposed upper part of
structure during the healing
period after inserting dental
implant fixture. When
inserting the Abutment,
Cover screw is removed. |
| Shelf Life | 5 Years | 5 Years | - |
| Similarities | The subject and predicate devices have same intended use, material, functions principle of
operation, shelf life and similar design and length as the primary predicate. | | |
| Differences | There are slightly different diameters between the subject and primary predicate device. K121585
was added to support the large diameters of the subject Cover Screw such as 6.9mm | | |

3) IT Healing Abutment

| | Subject Device | Primary
Predicate | Reference Devices | Reference Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Company | Neobiotech Co., Ltd | Neobiotech
Co., Ltd. | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| Device
Name | IT-III active System | Sinus Quick TM
IT System | CMI Implant IS System | Implantium Prosthetics |
| 510(k) | K181137 | K090527 | K120503 | K070228 |
| Indications
for Use | The IT-III active
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 | The Sinus
QuickTM
IT 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 | 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 | Implantium Prosthetic is
intended for use as an
aid in prosthetic
rehabilitation |
| | fixed bridgework. IT-
III active system is
dedicated for two
stage surgical
procedures and for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | retained,
oroverdenture
restorations,
and terminal or
intermediate
Abutment
support for
fixed
bridgework. IT
System
is dedicated for
two stage
surgical
procedures and
for immediate
loading | when there is good
primary stability and an
appropriate occlusal load. | |
| Material | Ti-6Al-4V ELI of
ASTM F136 | Ti-6Al-4V ELI
of
ASTM F136 | Ti-6Al-4V ELI of
ASTM F136 | Titanium Grade 4 of
ASTM F67 |
| Design | Image: Design 1 | Image: Design 2 | Image: Design 3 | Image: Design 4 |
| Diameters(Ø) | 5.8/6.3/7.1/7.2 | 5.5 | 4.8/5.5/6.0/6.8 | 4.0/4.5/5.5/6.5/7.5/8.5/9.5 |
| Cuff(mm) | 1.5/2.5/3.5/4.5/5.5/6.5 | 2.0/3.0/4.0 | 2.0/3.0/4.0/5.0/6.0/7.0/8.0 | 2.0/3.5/5.0/7.0 |
| Surface
Treatment | N/A | N/A | N/A | N/A |
| Sterilization | Gamma Sterilization | Gamma
Sterilization- | Gamma Sterilization | Gamma Sterilization |
| Principle of
Operation | This product is
healing Abutment to
formation appropriate
gingival shape during
the soft tissue healing
period combined with
implant. This product
should be removed
when the
superstructure is set
up. | This product is
healing
Abutment to
formation
appropriate
gingival shape
during the soft
tissue healing
period
combined with
implant. This
product should
be removed
when the
superstructure
is set up. | This product is healing
Abutment to formation
appropriate gingival
shape during the soft
tissue healing period
combined with implant.
This product should be
removed when the
superstructure is set up. | Implantium Prosthetic is
intended for use as an
aid in
prosthetic rehabilitation. |
| Shelf Life | 5 Years | 5 Years | 5 Years | - |
| Similarities | The subject and predicate devices have same intended use, material, function, principle of
operation, shelf life and general shape (design) and Cuff as the primary predicate. | | | |
| Differences | There are slightly different diameters and cuffs between the subject and primary predicate device.
K120503 was added to support the long lengths of the subject healing abutments such as
4.5,5.5and 6.5mm
K070228 was added to support the large diameters of the subject healing abutments such as 7.1
and 7.2mm | | | |

9

10

	4) IT Solid Abutment/IT Excellent Solid Abutment
--	--------------------------------------------------

	Subject Device	Primary Predicate	Reference Devices
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Dentium Co., Ltd.
Device Name	IT-III active System	Sinus Quick ™
IT System	SimpleLineII Abutment
System
510(k)	K181137	K090527	K112045
Indications for
Use	The IT-III active 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.
IT-III active system is
dedicated for two stage
surgical procedures and for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.	The Sinus Quick™ IT 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.
IT System is dedicated for two
stage surgical procedures and
for immediate loading	The SimpleLine II Abutment
is intended for use as an aid in
prosthetic rehabilitation.
Material	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136
IT Solid Abutment
Design	Image: IT-III active System Design	Image: Sinus Quick IT System Design	Image: SimpleLineII Abutment System Design
Diameters(Ø)	3.5/4.3	3.5/4.3	4.8/6.5
Lengths(mm)	4.0/5.5/7.0	4.0/5.5/7.0
Surface
Treatment	Andodizing/ Non-Anodizing	Andodizing/ Non-Anodizing	N/A
IT Excellent Solid Abutment
Design	Image: IT-III active System Design	Image: Sinus Quick IT System Design	-
Diameters(Ø)	4.35	5.2/5.7	-
Lengths(mm)	5.25/6.75	4.5/5.5/7.0	-
Surface
Treatment	Andodizing/ Non-Anodizing	Andodizing	Non-coating
Sterilization	N/A
components are end-user
sterilized	N/A
components are end-user
sterilized	N/A
components are end-user
sterilized
Principle of
Operation	This product is a
superstructure which is
connects with the fixture. It is
a one-body type Abutment of	This product is a
superstructure which is
connects with the fixture. It is
a one-body type Abutment of
screw-retained that does not	This product is a
superstructure which is
connects with the fixture. It is
a one-body type Abutment of
screw-retained that does not

11

| screw-retained that does not
require an Abutment screw. It
replaces the functions of the
missing teeth as a dental
Abutment | require an Abutment screw. It
replaces the functions of the
missing teeth as a dental
Abutment | require an Abutment screw. It
replaces the functions of the
missing teeth as a dental
Abutment. | |
|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----|
| Shelf Life | N/A | N/A | N/A |
| Similarities | The subject and predicate devices have same intended use, material, function, surface treatment
(Anodizing), principle of operation, shelf life and similar design and dimensions. | | |
| Differences | The dimensions are slightly different but it doesn't affect device's fundamental functions. | | |

5) Protective Cap

	Subject Device	Primary Predicate	Reference Devices
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Neobiotech Co., Ltd.
Device Name	IT-III active System	Sinus Quick TM IT System	CMI Implant IS System
510(k) Number	K181137	K090527	K120503
Indications for
Use	The IT-III active 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. IT-III
active system is dedicated for
two stage surgical procedures
and for immediate loading
when good primary stability is
achieved and with appropriate
occlusal loading.	The Sinus Quick™
IT 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, oroverdenture
restorations, and terminal or
intermediate Abutment
support for fixed bridgework.
IT System
is dedicated for two stage
surgical procedures and for
immediate loading	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.
Material	Polyoxymethylene(POM) of
ASTM F1855	Polyoxymethylene(POM) of
ASTM F1855	Polyoxymethylene(POM)of
ASTM F1855
Design	Image: Protective cap	Image: Protective cap	Image: Protective cap
Diameters(Ø)	5.45/7.2	5.45/7.2	4.5/5.2/5.7/6.5
Lengths(mm)	5.45/6.0/6.95/7.5/8.45/9.0	4.0/5.5/7.0	7.4/8.4/9.4
Surface
Treatment	N/A	N/A	N/A
Sterilization	N/A
components are end-user
sterilized	N/A
components are end-user
sterilized	N/A
components are end-user
sterilized
Principle of	Used to protect Solid	Used to protect Solid	Used to protect Solid
Operation	Abutments in the oral cavity.	Abutments in the oral cavity	Abutments in the oral cavity
Shelf Life	N/A	N/A	N/A
Similarities	The subject and primary predicate have same indications for use, functions, materials, surface
treatment, general shape (design) and diameters.
Differences	The design of the devices is slightly different but it doesn't affect device's fundamental functions.

12

	Subject Device	Primary Predicate	Reference Devices
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.	OSSTEM Implant Co., Ltd..
Device Name	IT-III active System	Sinus Quick ™ IT System	TS Implant System
510(k)	K181137	K090527	K121585
Indications for Use	The IT-III active 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.	The Sinus Quick™ IT 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. IT System is dedicated for two stage surgical procedures and for immediate loading	The TS 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture. TS Implant System is compatible with abutment in the ET/SS Implant System.
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
IT Cemented Abutment
Design	Image: Octa	Image: Octa	Image: Hex/Non-Hex
	Octa
Non-Octa
SCRP	Octa
Non-Octa	Hex/Non-Hex
Diameters(Ø)	4.3/4.85/5.5/6.55	5.2/5.7	4.5/5.5/6.5	4.5/5.0/6.0/7.0
Lengths(mm)	5.8/6.0	4.5/5.5/6.0/7.0/8.0	9.2~13.7	4.0/5.5/7.0
Surface Treatment	TiN-Coating	TiN-Coating	TiN-Coating
IT Collared Angled Abutment
Design	Image: Octa	Image: Non-Octa	Image: Octa	Image: Non-Octa	Image: Hex/Non-Hex
Diameters(Ø)	5.5		5.2/5.7	4.5/5.5	4.5/5.0/6.0
Lengths(mm)	7		7	13.3	8
Angle (°)	15/25		15/25	15/25	17
Surface Treatment	TiN-Coating		TiN-Coating	TiN-Coating	TiN-Coating
IT Pre Angled Abutment
Design	Image: Octa	Image: Non-Octa	Image: Octa	Image: Non-Octa
Diameters(Ø)	3.7/4.3		3.5		-
Lengths(mm)	9.5/9.68		9.5		-
Angle (°)	15/25		15/25	15/25	-
Surface Treatment	N/A		N/A	N/A	-
Sterilization	N/A
components are end-user sterilized		N/A
components are end-user sterilized	N/A
components are end-user sterilized
Principle of Operation	This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental Abutment.		This product is a superstructure which is connect with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental Abutment.	This product is a superstructure which is connect with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental Abutment.	This product is a superstructure which is connect with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental Abutment.
Shelf Life	N/A		N/A	N/A	N/A
Similarities	The subject and predicate devices have same intended use, material, function, coating material (TiN), angulation, principle of operation, and general shape (design) and dimensions.
Differences	The dimensions are slightly different but it doesn't affect device's fundamental functions.
There are slightly different diameters and lengths between the subject and primary predicate device.
K052957 was added to support the long lengths of the subject Cemented Abutment, Collared Angled Abutment, Pre Angled Abutment
K121585 was added to support the large diameters of the subject Cemented Abutment such as
		Subject Device	Primary Predicate	Reference Devices
Company		Neobiotech Co., Ltd	Neobiotech Co., Ltd.	Dentium Co., Ltd.
Device Name		IT-III active System	Sinus Quick TM IT System	Implantium® / SuperLine®
Prosthetics
510(k)		K181137	K090527	K160828
Indications for
Use		The IT-III active 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.
IT-III active system is
dedicated for two stage
surgical procedures and for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.	The Sinus Quick™ IT 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. IT System
is dedicated for two stage
surgical procedures and for
immediate loading	Dentium Implantium®/
SuperLine® Prosthetics is
intended for use as an aid
in prosthetic rehabilitation
Material		Gold Alloy /
Polyoxymethylene(POM) of
ASTM F1855	Gold Alloy /
Polyoxymethylene(POM) of
ASTM F1855	Gold Alloy /
Polyoxymethylene(POM) of
ASTM F1855
Design,		Image: Octa
Image: Non-Octa	Image: Octa
Image: Non-Octa	Image:
Diameters(Ø)		5.5	5.5	4.5
Lengths(mm)		10	13	19.2
Surface
Treatment		N/A	N/A	N/A
Sterilization		N/A
components are end-user
sterilized	N/A
components are end-user
sterilized	N/A
components are end-user
sterilized
Principle of
Operation		It is used when there are
restrictions on the prosthesis
production because of path,
aesthetics, and space of
fixture. Production the
prosthesis by casting with
dental alloy after wax up with
desired shape	It is used when there are
restrictions on the prosthesis
production because of path,
aesthetics, and space of
fixture. Production the
prosthesis by casting with
dental alloy after wax up with
desired shape	It is used when there are
restrictions on the prosthesis
production because of path,
aesthetics, and space of fixture.
Production the prosthesis by
casting with dental alloy after
wax up with desired shape.
Shelf Life	N/A
Similarities
Differences	The subject and predicate devices have same intended use, material, function, principle of
operation, and general shape (design) and dimensions
The dimensions are slightly different but it doesn't affect device's fundamental functions

6) IT Cemented Abutment/ IT Collared Angled Abutment /IT Pre Angled Abutment

13

14

7) IT Gold UCLA Abutment

15

	Subject Device	Primary Predicate
Company	Neobiotech Co., Ltd	Neobiotech Co., Ltd.
Device Name	IT-III active System	Sinus Quick TM IT System
510(k)	K181137	K090527
Indications for
Use	The IT-III active 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. IT-III active system is
dedicated for two stage surgical procedures and
for immediate loading when good primary
stability is achieved and with appropriate
occlusal loading.	The Sinus Quick™
IT 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,
oroverdenture restorations, and terminal or
intermediate Abutment support for fixed
bridgework. IT System
is dedicated for two stage surgical procedures
and for immediate loading
Material	Ti-6Al-4V ELI of ASTM F136	Ti-6Al-4V ELI of ASTM F136
IT Cemented Abutment Screw
Design	Image: IT Cemented Abutment Screw	Image: IT Cemented Abutment Screw
Diameters(Ø)	2.55	2.55
Length(mm)	7.55	7.55
IT Angled Abutment Screw
Design	Image: IT Angled Abutment Screw	-
Diameters(Ø)	2.55	-
Length(mm)	6.75	-
Surface
Treatment	N/A	N/A
Sterilization	N/A
components are end-user sterilized	N/A
components are end-user sterilized
Principle of
Operation	This product is a screw for connected with
Abutment and fixture.	This product is a screw for connected with
Abutment and fixture
Shelf Life	N/A	N/A
Similarities	The subject and primary predicate have same indications for use, functions, materials, surface
treatment, general shape (design) and diameters.
Differences	The design of the devices is slightly different but it doesn't affect device's fundamental functions
and substantial equivalence to the declared predicates.

8) IT Cemented Abutment Screw/ IT Angled Abutment Screw

Similarities:

The IT-III active Fixture has same device characteristics with the Primary predicate devices, Sinus Quick™ IT System (K090527)such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar.

16

The IT-III active Abutments are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics as predicate devices.

The subject device has been supposed to performance and product validations prior to release. Testing including performance and fatigue test has been finished to ensure the devices comply with the applicable International and US FDA Guidance.

Differences:

The differences between the subject device and the primary predicate device are surface treatment. The surface treatment method of the subject fixture is SLA (Sandblasted with Large-grit and Acid-etching) and the surface treatment method of the primary Predicate device is RBM (Resorbable Blasting Media). To support this discrepancy. K120503 was selected as reference predicate for the fixtures. Another difference between the subject and primary predicate device are the addition of diameters above 5.0 mm and lengths less than 8.5 mm. However, our reference predicate, K120503 includes the fixtures that meet or exceed diameters above 5.0 mm and lengths less than 8.5 mm in this submission, these differences do not raise any question of substantial equivalence to the declared predicates.

Non-clinical testing data:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

• Fatigue Testing according to ISO 14801:2016 under the worst-case scenario ●
• Sterilization Testing according to ISO 11137-1:2006. ISO 11137-2:2013, and ISO 11137-. 3:2006
• Shelf Life Testing according to ASTM F1980
• Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP
• . Biocompatibility Evaluation according to ISO 10993-1:2009

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Biocompatibility Test conducted on our own predicate device, K181138 was leveraged for the subject device, and it demonstrates that the subject device is biocompatible.

Fatigue testing for IT-III active fixture and angled Abutment was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801:2016 Dentistry - Fatigue test for endosseous dental implants under the worst-case scenario to ensure that the subject device is strong enough for its intended use.

End user sterilization Validation performed on our own predicate device, K181138 was leveraged for the subject device.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion

IT-III active System constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, IT-III active System and its predicates are substantially equivalent.