(200 days)
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.
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 provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.
The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.
However, I can extract the information provided that is relevant, or indicate where the information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.
| Acceptance Criteria (Implied from testing standards) | Reported Device Performance |
|---|---|
| Fatigue strength according to ISO 14801:2016 | Met the criteria of the standard. |
| Sterility according to ISO 11137-1:2006, -2:2013, -3:2006 | Met the criteria of the standard. |
| Shelf life according to ASTM F1980 | Met the criteria of the standard. |
| Bacterial Endotoxin according to ANSI/AAMI ST72:2011, USP <161>, <85> | Met the criteria of the standard. |
| Biocompatibility according to ISO 10993-1:2009 | Met the criteria of the standard (leveraged from predicate K181138). |
| End-user sterilization validation (for non-sterile components) | Met the criteria of the standard (leveraged from predicate K181138). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.
8. The sample size for the training set
No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set described.
{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
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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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{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
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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 andconnecting part with exposed upper part ofstructure during the healing period afterinserting dental implant fixture | N/A | |
| IT HealingAbutment | Used to formation appropriate gingivalshape during the soft tissue healing periodcombined with implant | N/A | Screwretained |
| IT Solid Abutment | Anodizing(Blue/yellow)Non-Anodizing, | ||
| IT Excellent SolidAbutment | Non-Anodizing, | ||
| IT CementedAbutment | The Abutment is connected with fixture andit supports prosthesis which restores toothfunction. | TiN-Coating | InternalOcta,Non-Octa,SCRP |
| IT Pre AngledAbutment | N/A | ||
| IT Collared AngledAbutment | TiN-Coating | Internal,Octa,Non-Octa | |
| IT Gold UCLAAbutment | N/A | ||
| Protective Cap | Used to protect Solid Abutments in the oralcavity. | N/A | - |
| IT CementedAbutment screw | It is used to fix Abutment at the top offixture. | N/A | |
| IT AngledAbutment 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 |
| DeviceClassificationName | 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 forUse | The IT-III active system isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. IT-IIIactive system is dedicated fortwo stage surgical proceduresand for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. | The Sinus Quick™ IT Systemis indicated for use in partiallyor fully edentulous mandiblesand maxillae,in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateAbutment support for fixedbridgework. IT Systemis dedicated for two stagesurgical procedures and forimmediate loading | The CMI Implant IS II activeis intended to be surgicallyplaced in the bone of the upperor lower jaw arches to providesupport for prosthetic devices,such as artificial teeth, and torestore the patient's chewingfunction. It is intended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. |
| 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-RotationalFeature | 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 |
| SurfaceTreatment | SLA | RBM | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle ofOperation | This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture. | This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture. | This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teethas 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, SinusQuick 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 treatmentand upper part design. The surface treatment method of the subject fixture is SLA (Sandblastedwith Large-grit and Acid-etching) and the surface treatment method of the primary Predicatedevice is RBM (Resorbable Blasting Media). To support this discrepancy, K120503 was added asreference 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 a0.1 mm difference in screw pitch between 0.9 and 0.8. These differences do not raise any questionof 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. |
| DeviceName | IT-III active System | Sinus Quick TM IT System | TS Implant System |
| 510(k)Number | K181137 | K090527 | K121585 |
| Indicationsfor Use | The IT-III active system isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of singleor multiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. IT-IIIactive system is dedicated fortwo stage surgical proceduresand for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. | The Sinus Quick™ IT Systemis indicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. ITSystem is dedicated for twostage surgical procedures andfor immediate loading | The TS Implant System isindicated for use in partiallyor fully edentulousmandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained,screw retained, oroverdenture restorations,and final or temporaryabutment support forfixed bridgework. It isintended for delayedloading. The abutment isintended for use witha dental implant fixture toprovide support forprosthetic restorations suchas crowns,bridges, or overdenture. |
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| TS Implant System iscompatible with abutment inthe ET/SS Implant System | |||
|---|---|---|---|
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTMF136 |
| 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 | - |
| SurfaceTreatment | N/A | N/A | Anodizing |
| Sterilization | Gamma Sterilization | Gamma Sterilization | - |
| Principle ofOperation | Cover screw as a set of medicaldevices is used for protectinginner hole and connecting partwith exposed upper part ofstructure during the healingperiod after inserting dentalimplant fixture. When insertingthe Abutment,Cover screw is removed. | Cover screw as a set of medicaldevices is used for protectinginner hole and connecting partwith exposed upper part ofstructure during the healingperiod after inserting dentalimplant fixture. When insertingthe Abutment, Cover screw isremoved. | Cover screw as a set ofmedical devices is used forprotecting inner hole andconnecting part withexposed upper part ofstructure during the healingperiod after inserting dentalimplant fixture. Wheninserting 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 ofoperation, shelf life and similar design and length as the primary predicate. | ||
| Differences | There are slightly different diameters between the subject and primary predicate device. K121585was added to support the large diameters of the subject Cover Screw such as 6.9mm |
3) IT Healing Abutment
| Subject Device | PrimaryPredicate | Reference Devices | Reference Device | |
|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | NeobiotechCo., Ltd. | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| DeviceName | IT-III active System | Sinus Quick TMIT System | CMI Implant IS System | Implantium Prosthetics |
| 510(k) | K181137 | K090527 | K120503 | K070228 |
| Indicationsfor Use | The IT-III activesystem is indicatedfor use in partially orfully edentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screwretained, or | The SinusQuickTMIT System isindicated foruse in partiallyor fullyedentulousmandibles andmaxillae,insupport ofsingle ormultiple-unitrestorationsincluding;cementedretained. screw | The CMI Implant ISSystem is indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate Abutmentsupport for fixedbridgework. IS System isdedicated for two stagesurgical procedures andfor immediate loading | Implantium Prosthetic isintended for use as anaid in prostheticrehabilitation |
| fixed bridgework. IT-III active system isdedicated for twostage surgicalprocedures and forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading. | retained,oroverdenturerestorations,and terminal orintermediateAbutmentsupport forfixedbridgework. ITSystemis dedicated fortwo stagesurgicalprocedures andfor immediateloading | when there is goodprimary stability and anappropriate occlusal load. | ||
| Material | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELIofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Titanium Grade 4 ofASTM 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 |
| SurfaceTreatment | N/A | N/A | N/A | N/A |
| Sterilization | Gamma Sterilization | GammaSterilization- | Gamma Sterilization | Gamma Sterilization |
| Principle ofOperation | This product ishealing Abutment toformation appropriategingival shape duringthe soft tissue healingperiod combined withimplant. This productshould be removedwhen thesuperstructure is setup. | This product ishealingAbutment toformationappropriategingival shapeduring the softtissue healingperiodcombined withimplant. Thisproduct shouldbe removedwhen thesuperstructureis set up. | This product is healingAbutment to formationappropriate gingivalshape during the softtissue healing periodcombined with implant.This product should beremoved when thesuperstructure is set up. | Implantium Prosthetic isintended for use as anaid inprosthetic rehabilitation. |
| Shelf Life | 5 Years | 5 Years | 5 Years | - |
| Similarities | The subject and predicate devices have same intended use, material, function, principle ofoperation, 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 as4.5,5.5and 6.5mmK070228 was added to support the large diameters of the subject healing abutments such as 7.1and 7.2mm |
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| 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 AbutmentSystem |
| 510(k) | K181137 | K090527 | K112045 |
| Indications forUse | The IT-III active system isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IT-III active system isdedicated for two stagesurgical procedures and forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. | The Sinus Quick™ IT Systemis indicated for use in partiallyor fully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IT System is dedicated for twostage surgical procedures andfor immediate loading | The SimpleLine II Abutmentis intended for use as an aid inprosthetic rehabilitation. |
| Material | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM 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 | |
| SurfaceTreatment | 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 | - |
| SurfaceTreatment | Andodizing/ Non-Anodizing | Andodizing | Non-coating |
| Sterilization | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized |
| Principle ofOperation | This product is asuperstructure which isconnects with the fixture. It isa one-body type Abutment of | This product is asuperstructure which isconnects with the fixture. It isa one-body type Abutment ofscrew-retained that does not | This product is asuperstructure which isconnects with the fixture. It isa one-body type Abutment ofscrew-retained that does not |
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| screw-retained that does notrequire an Abutment screw. Itreplaces the functions of themissing teeth as a dentalAbutment | require an Abutment screw. Itreplaces the functions of themissing teeth as a dentalAbutment | require an Abutment screw. Itreplaces the functions of themissing teeth as a dentalAbutment. | |
|---|---|---|---|
| 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 forUse | The IT-III active system isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. IT-IIIactive system is dedicated fortwo stage surgical proceduresand for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. | The Sinus Quick™IT System is indicated for usein partially or fully edentulousmandibles and maxillae,insupport of single or multiple-unit restorations including;cemented retained, screwretained, oroverdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IT Systemis dedicated for two stagesurgical procedures and forimmediate loading | The CMI Implant IS System isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IS System is dedicated for twostage surgical procedures andfor immediate loading whenthere is good primary stabilityand an appropriate occlusalload. |
| Material | Polyoxymethylene(POM) ofASTM F1855 | Polyoxymethylene(POM) ofASTM F1855 | Polyoxymethylene(POM)ofASTM 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 |
| SurfaceTreatment | N/A | N/A | N/A |
| Sterilization | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized |
| 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, surfacetreatment, general shape (design) and diameters. | ||
| Differences | The design of the devices is slightly different but it doesn't affect device's fundamental functions. |
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| 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 | ||
| OctaNon-OctaSCRP | OctaNon-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/Acomponents are end-user sterilized | N/Acomponents are end-user sterilized | N/Acomponents 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 AbutmentK121585 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 forUse | The IT-III active system isindicated for use in partially orfully edentulous mandiblesand maxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixed bridgework.IT-III active system isdedicated for two stagesurgical procedures and forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading. | The Sinus Quick™ IT Systemis indicated for use in partiallyor fully edentulous mandiblesand maxillae,in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, oroverdenture restorations, andterminal or intermediateAbutment support for fixedbridgework. IT Systemis dedicated for two stagesurgical procedures and forimmediate loading | Dentium Implantium®/SuperLine® Prosthetics isintended for use as an aidin prosthetic rehabilitation | ||
| Material | Gold Alloy /Polyoxymethylene(POM) ofASTM F1855 | Gold Alloy /Polyoxymethylene(POM) ofASTM F1855 | Gold Alloy /Polyoxymethylene(POM) ofASTM F1855 | ||
| Design, | Image: OctaImage: Non-Octa | Image: OctaImage: Non-Octa | Image: | ||
| Diameters(Ø) | 5.5 | 5.5 | 4.5 | ||
| Lengths(mm) | 10 | 13 | 19.2 | ||
| SurfaceTreatment | N/A | N/A | N/A | ||
| Sterilization | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized | N/Acomponents are end-usersterilized | ||
| Principle ofOperation | It is used when there arerestrictions on the prosthesisproduction because of path,aesthetics, and space offixture. Production theprosthesis by casting withdental alloy after wax up withdesired shape | It is used when there arerestrictions on the prosthesisproduction because of path,aesthetics, and space offixture. Production theprosthesis by casting withdental alloy after wax up withdesired shape | It is used when there arerestrictions on the prosthesisproduction because of path,aesthetics, and space of fixture.Production the prosthesis bycasting with dental alloy afterwax up with desired shape. | ||
| Shelf Life | N/A | ||||
| SimilaritiesDifferences | The subject and predicate devices have same intended use, material, function, principle ofoperation, and general shape (design) and dimensionsThe 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
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7) IT Gold UCLA Abutment
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| 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 forUse | The IT-III active system is indicated for use inpartially or fully edentulous mandibles andmaxillae, in support of single or multiple-unitrestorations including; cemented retained,screw retained, or overdenture restorations, andterminal or intermediate Abutment support forfixed bridgework. IT-III active system isdedicated for two stage surgical procedures andfor immediate loading when good primarystability is achieved and with appropriateocclusal loading. | The Sinus Quick™IT System is indicated for use in partially orfully edentulous mandibles and maxillae,insupport of single or multiple-unit restorationsincluding; cemented retained, screw retained,oroverdenture restorations, and terminal orintermediate Abutment support for fixedbridgework. IT Systemis dedicated for two stage surgical proceduresand 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 | - |
| SurfaceTreatment | N/A | N/A |
| Sterilization | N/Acomponents are end-user sterilized | N/Acomponents are end-user sterilized |
| Principle ofOperation | This product is a screw for connected withAbutment and fixture. | This product is a screw for connected withAbutment and fixture |
| Shelf Life | N/A | N/A |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surfacetreatment, general shape (design) and diameters. | |
| Differences | The design of the devices is slightly different but it doesn't affect device's fundamental functionsand 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.
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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 <161>, and USP <85>
- . 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.
§ 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.