Who is the manufacturer of IT-III active System?

Neobiotech Co., Ltd. filed the 510(k) submission for IT-III active System (K181137).

What is the FDA product code for IT-III active System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for IT-III active System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IT-III active System?

Sinus Quick TM IT System (K090527).

Who can help prepare an FDA 510(k) submission like IT-III active System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IT-III active System

K181137 · Neobiotech Co., Ltd. · DZE · Nov 16, 2018 · Dental

Device Facts

Record ID	K181137
Device Name	IT-III active System
Applicant	Neobiotech Co., Ltd.
Product Code	DZE · Dental
Decision Date	Nov 16, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

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 Story

The IT-III active System is an endosseous dental implant system consisting of a root-form fixture and various abutments. The fixture is surgically placed into the alveolar bone of the mandible or maxilla to replace missing teeth. The fixture features an internal octa connection and an SLA (sandblasted, large-grit, acid-etched) surface treatment. Abutments, including healing, solid, cemented, and angled types, are attached to the fixture to support prosthetic restorations. The system is used by dental clinicians in a clinical setting. The device provides a stable foundation for crowns, bridges, or overdentures, restoring chewing function and aesthetics for the patient. The system supports both two-stage surgical protocols and immediate loading when primary stability is achieved.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including fatigue testing (ISO 14801:2016), sterilization validation (ISO 11137 series), shelf-life testing (ASTM F1980), bacterial endotoxin testing (ANSI/AAMI ST72, USP <161>, USP <85>), and biocompatibility evaluation (ISO 10993-1:2009). Biocompatibility and sterilization data were leveraged from predicate device K181138.

Technological Characteristics

Fixture: Pure titanium (ASTM F67), SLA surface. Abutments: Ti-6Al-4V ELI (ASTM F136), some with TiN-coating. Protective caps/UCLA components: Polyoxymethylene (ASTM F1855) and Gold Alloy. Connection: Internal Octa. Sterilization: Gamma for fixtures/some abutments; others end-user sterilized. Dimensions: Various diameters (3.5-7.0mm) and lengths. No software or active electronic components.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Suitable for two-stage surgical procedures and immediate loading given sufficient primary stability and appropriate occlusal loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Sinus Quick TM IT System (K090527)

Reference Devices

Implantium Prosthetics (K052957)
Implantium Prosthetics (K070228)
Simple Line II Abutment system (K112045)
CMI Implant IS II active (K120503)
TS Implant System (K121585)
Implantium® / SuperLine® Prosthetics (K160828)
IS-III active System (K181138)

Related Devices

K181138 — IS-III active System · Neobiotech Co., Ltd. · Oct 3, 2018
K190849 — IS-III active System_S-narrow Type · Neobiotech Co., Ltd. · Aug 14, 2019
K192294 — I Do · I DO Biotech Co., Ltd. · Jul 31, 2020
K210039 — CORE1 Implant System · Cybermed, Inc. · Jan 7, 2022
K170608 — UF(II) Implant System · Dio Corporation · Mar 30, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ #### 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary #### Submitter Neobiotech Co.. Ltd. Young-Ku, Heo #312-1, 36, Digital-ro 27 gil Guro-gu. Seoul 08381 South Korea Email: kylee@neobiotech.com Tel. +82-2-582-2885 Fax. +82-2-582-2883 #### 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: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122 {4}------------------------------------------------ ## 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 | {5}------------------------------------------------ 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. {6}------------------------------------------------ #### 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 {7}------------------------------------------------ | 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. | {8}------------------------------------------------ | | | | 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 |…