(156 days)
The IS-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. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 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 hex. 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). There are 4 types of fixtures in this system and the dimensions are as following: Tolerance of dimension shall be within ± 1% range. IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw. The dimensions of abutments are as following: Tolerance of dimension for Abutments shall be within ± 1% range. The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated. IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized. IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap. All of above products including enclosed product are packed separately for convenience.
The provided document is a 510(k) Premarket Notification for a dental implant system. It outlines the characteristics of the IS-III active System and compares it to predicate devices to demonstrate substantial equivalence, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for an AI/ML powered device.
Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.
However, I can extract information related to the device's non-clinical testing and comparison to acceptance criteria (standards).
Here's the closest representation of the requested information based on the provided document:
Acceptance Criteria and Device Performance Study for the Neobiotech IS-III active System (K181138)
This 510(k) submission establishes the substantial equivalence of the IS-III active System to legally marketed predicate devices primarily through comparison of technological characteristics and non-clinical performance testing against recognized standards. The acceptance criteria are derived from these international and internal standards, and the device's performance data is reported as meeting these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Applied Component(s) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ||
| ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1) | Fixtures | Met the criteria of the standard. Biocompatible. |
| ISO 10993-3:2014 (Genotoxicity, carcinogenicity and reproductive toxicity) | Fixtures | Met the criteria of the standard. |
| ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Fixtures | Met the criteria of the standard. |
| ISO 10993-6:2007 (Tests for local effects after implantation) | Fixtures | Met the criteria of the standard. |
| ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Fixtures | Met the criteria of the standard. |
| ISO 10993-11:2006 (Tests for systemic toxicity) | Fixtures | Met the criteria of the standard. |
| Fatigue Testing: | ||
| ISO 14801:2016 (Dentistry - Fatigue test for endosseous dental implants) | IS-III active Fixture, Angled Abutment | Met the criteria of the standard under worst-case scenario. |
| FDA Class II Special Controls Guidance Document | IS-III active Fixture, Angled Abutment | Met the criteria of the guidance document. |
| Sterilization Validation: | ||
| ANSI/AAMI ST72:2011 & USP <161>, USP <85> (Bacterial Endotoxin) | All components | Met the criteria; endotoxin levels acceptable. |
| ANSI/AAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1 (End User Sterilization) | Non-sterilized abutments | Test reports leveraged from predicate based on material/process similarity. |
| ISO 11137-1/2/3 (Gamma Sterilization) | Fixtures, Healing Abutments | Met the criteria; sterilization effective. |
| Shelf Life: | ||
| ASTM F1980, F1140, F1929, F2096 | Fixtures, Healing Abutments | 5 years shelf life demonstrated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing or biocompatibility animal models) are not detailed in this summary document.
- Data Provenance: The document does not specify the country of origin for the non-clinical testing data nor if it was retrospective or prospective, as these are typically not relevant for non-clinical bench or lab testing. The testing was conducted to international and US FDA recognized standards.
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 information is not applicable as the document describes non-clinical engineering and biological tests conducted against established standards, not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical engineering and biological tests.
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
This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility and mechanical testing, the "ground truth" is defined by the established criteria and methodologies within the cited international ISO and ASTM standards, as well as the FDA guidance document. For example, for fatigue, the "ground truth" is that the device must withstand a certain number of cycles at a specified load without failure, as per ISO 14801.
8. The sample size for the training set
This information is not applicable. This document is for a physical medical device. There is no AI/ML algorithm or "training set" involved in its development or evaluation as described here.
9. How the ground truth for the training set was established
This information is not applicable. No training set is mentioned or relevant to the information provided in this 510(k) summary for a physical dental implant.
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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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
October 3, 2018
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K181138
Trade/Device Name: IS-III active System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 30, 2018 Received: September 6, 2018
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K181138
Device Name IS-III active System
Indications for Use (Describe)
The IS-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. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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{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: sakim@neobiotech.com Tel. +82-2-582-2885 Fax. +82-2-582-2883
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
Device Information
- Trade Name: IS-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: 10/03/2018
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. ●
Reference Devices -
. K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd
-
K160828, Dentum Implantium® / SuperLine® Prosthetics manufactured by Dentium Co., Ltd.
-
K173938, IS-III HActive Fixture manufactured by Neobiotech Co., Ltd. ●
-
K070228, Implantium Prosthetics by Dentium Co.,Ltd. ●
Indications for Use:
The IS-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. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
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Device Description
IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 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 hex.
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).
| Fixture Type | Diameter (mm) | Length (mm) |
|---|---|---|
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0/7.0 | 7.3/8.5/10.0/11.5/13.0 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0 | 7.3/8.5/10.0/11.5/13.0 |
| Image: Dental Implant | Ø 7.0 | 7.3/8.5/10.0/11.5 |
| Image: Dental Implant | Ø 3.5 | 8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Image: Dental Implant | Ø 6.0/7.0 | 7.3/8.5/10.0/11.5/13.0 |
There are 4 types of fixtures in this system and the dimensions are as following:
Tolerance of dimension shall be within ± 1% range.
IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw.
The dimensions of abutments are as following:
| Name | Diameter (mm) | Length of Cuff (mm) | |
|---|---|---|---|
| IS Cover Screw | Ø 3.45 | 5.85/6.85/7.45 | |
| Ø 3.6 | 6.4/7.4/8.0 | ||
| IS Healing Abutment | Ø 4.8/5.5/6.0/6.8 | Cuff: 2.8/3.8/4.8/5.8/6.8/7.8 | |
| Ø 4.0/4.5 | Cuff: 2.3/3.3/4.3/5.3/6.3 | ||
| Ø 8.0/9.0 | Cuff: 2.8/3.8/4.8 | ||
| IS Encoded Healing | Body | Ø 4.0/4.6 | Cuff: 3.3/4.3/5.3/6.3/7.3 |
| Ø 5.3/5.8/6.6/8.0/9.0 | Cuff: 2.3/3.3/4.3/5.3 | ||
| Screw | Ø 2.3 | 8.4/9.4/10.4/11.4/12.4/13.4 | |
| IS Solid Abutment | Ø 4.5/5.2/5.7/6.5 | 4.0/4.5/5.5/7.0 | |
| Protective cap | Ø 5.0/5.7/6.2 | 5.5/6.3/7.3/8.8 | |
| Ø 7.1 | 5.5/6.3/7.75/9.25 |
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| IS Cemented Abutment | Ø 4.5/5.2/5.7 | 4.0/4.5/5.5/7.0/8.0 | |
|---|---|---|---|
| *Ø6.5 | 4.0/4.5/5.5/7.0/8.0 | ||
| **Ø4.5 | 5.5/7.0 | ||
| **Ø5.2/5.7 | 4.0/4.5/5.5/7.0 | ||
| IS Shapable Abutment | Ø 4.5/5.2/5.7 | 8.1/11.1 | |
| Ø 6.5 | 8.1 | ||
| IS Angled Abutment | Ø 4.5/5.2/5.7 | 7.0 | |
| IS Ball Abutment | Ø 3.5 | 11.1/12.1/13.1/14.1 | |
| IS Ball Abutment_component | Housing | Ø 5.0 | 4.0 |
| Retainer | Ø 5.0 | 2.0 | |
| O-ring | Ø 4.6 | - | |
| Ø 4.7 | - | ||
| IS Gold UCLA Abutment | Ø 4.5 | 10.0 | |
| IS Temporary Abutment | Ø 4.5 | 6.0/8.0/11.5 | |
| Abutment Screw | Ø 2.3 | 8.8/8.3 |
- Not all Ø6.5 diameter abutments are available in 8.0 length.
** Theses are a separate type of IS Cemented Abutment.
The features of each abutment are as following:
| Name | Uses | SurfaceTreatment | Connection |
|---|---|---|---|
| IS Cover Screw | It is used for protecting inner holeand connecting part with exposedupper part of structure during thehealing period after inserting dentalimplant fixture | Anodizing(yellow),Non-Anodizing | ScrewRetained |
| IS Healing Abutment | Used to formation appropriategingival shape during the soft tissuehealing period combined withimplant | N/A | Screw Retained |
| IS Encoded HealingAbutment | N/A | Internal Hex | |
| IS Solid Abutment | The Abutment is connected withfixture and it supports prosthesiswhich restores tooth function. | TiN-Coating | ScrewRetained |
| IS Cemented Abutment | Internal Hex, Non-Hex, | ||
| IS Shapable Abutment | SCRP | ||
| IS Angled Abutment | Internal Hex, Non-Hex | ||
| IS Ball Abutment | N/A | Screw Retained | |
| IS Gold UCLAAbutment | N/A | Internal Hex, Non-Hex,SCRP | |
| IS Temporary Abutment | N/A | N/A | |
| Protective Cap | Used to protect Solid Abutments inthe oral cavity. | N/A | - |
| IS Abutment Screw | It is used to fix Abutment at the topof fixture | N/A | ScrewRetained |
Tolerance of dimension for Abutments shall be within ± 1% range.
The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated.
{6}------------------------------------------------
IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized.
IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap.
All of above products including enclosed product are packed separately for convenience.
Materials:
- . The Fixtures are made of TI CP4 of ASTM F67.
- . The Abutments (IS Cover Screw, IS Healing Abutment, IS Encoded Abutment, IS Solid Abutment, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Temporary Abutment, IS Abutment Screw) are fabricated from Ti-6A1-4V ELI of ASTM F136.
- The IS 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.
- . The IS Ball Abutment attachments are fabricated from Ti-6Al-4V ELI of ASTM F136(Housing, Retainer) and Silicon(O-ring).
Summaries of Technological Characteristics:
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | CMI Implant IS II active |
| 510(k) Number | K181138 | K113554 | K120503 |
| DeviceClassificationName | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous, Root-Form |
| Product Code | DZE | DZE | DZE |
| RegulationNumber | 872.3640 | 872.3640 | 872.3640 |
| Indications forUse | The IS-III active System isindicated 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.IS-III active System isdedicated for two stagesurgical procedures and forimmediate loading when thereis good primary stability andan appropriate occlusal load. | The CMI Implant IS System isindicated 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.IS System is dedicated for twostage surgical procedures andfor immediate loading whenthere is good primary stabilityand an appropriate occlusalload. Also, implants with | The CMI Implant IS II activeis intended to be surgicallyplaced in the bone of theupper or lower jaw arches toprovide support for prostheticdevices, such as artificialteeth, and to restore thepatient's chewing function. Itis intended for immediateloading when good primarystability is achieved and withappropriate occlusal loading. |
1) IS-III active Fixture
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| Also, implants with diameterslarger than 5mm are indicatedfor molar regions. | diameters larger than 5mm areindicated for molar regions. | diameters larger than 5mm areindicated for molar regions. | |
|---|---|---|---|
| Material | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
| Design | Image: dental implant | Image: dental implant | Image: dental implant |
| Anti-RotationalFeature | Internal Hex | Internal Hex | Internal Hex |
| Diameters(Ø) | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0 |
| Lengths(mm) | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | 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. |
| Similarities | The IS-III active Fixture has same device characteristics with the Primary predicate devices, CMIImplant IS System (K113554) such as diameters, Length, intended use, material, functions,general shape (Design), structure and applied production method are similar. | ||
| Differences | The differences between the subject device and the primary predicate device is surface treatmentsand product design. The surface treatment method of the predicate fixture is RBM (ResorbableBlasting Media) and the surface treatment method of the subject device is SLA (Sandblasted withLarge-grit and Acid-etching). To support this discrepancy, K120503 was added as a referencedevice which was treated with SLA method. |
2) IS Cover Screw
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | IS-III HActive Fixture |
| 510(k)Number | K181138 | K113554 | K173938 |
| Material | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI ofASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Design of IS-III active System | Image: Design of CMI Implant IS System | Image: Design of IS-III HActive Fixture |
| Diameters(Ø) | 3.45/3.6 | 3.19/3.35 | 3.45/3.6 |
| Lengths(mm) | 5.85/6.85/7.45/6.4/7.4/8.0/ | 5.45/5.85 | 5.85/6.85/7.45/6.4/7.4/8.0/ |
| SurfaceTreatment | Anodizing/ Non-Anodizing, | N/A | Anodized/Non-Anodized |
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| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
|---|---|---|---|
| Principle ofOperation | It is used for protecting innerhole and connecting part withexposed upper part ofstructure during the healingperiod after inserting dentalimplant fixture. Wheninserting the Abutment,Cover screw is removed. | It is used for protecting innerhole and connecting part withexposed upper part ofstructure during the healingperiod after inserting dentalimplant fixture. Wheninserting the Abutment,Cover screw is removed. | It is used for protecting inner holeand connecting part with exposedupper part of structure during thehealing period after insertingdental implant fixture. Wheninserting the Abutment, Coverscrew is removed |
| Similarities | The subject device has same intended use, material, functions, principle of operation, shelf life andsimilar design and dimensions. | ||
| Differences | There are slightly different designs and dimensions. Also, the subject device includes anodizedcover screw. To support the dimension, K173983 was referenced. This change doesn't affectproduct's fundamental function, safety and effectiveness. |
3) IS Healing Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | Implantium Prosthetics |
| 510(k) Number | K181138 | K113554 | K070228 |
| Material | Ti-6Al-4V ELI of ASTMF136 | Ti-6Al-4V ELI of ASTM F136 | Titanium Grade 4 of ASTMF67 |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design |
| Diameters (Ø) | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 | 4.8/5.5/6.0/6.8 | 4.0/4.5/5.5/6.5/7.5/8.5/9.5 |
| Cuff(mm) | 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8/ | 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 |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle ofOperation | This product is healingAbutment to formationappropriate gingival shapeduring the soft tissue healingperiod combined with implant.This product should beremoved when thesuperstructure is set up. | This product is healingAbutment to formationappropriate gingival shapeduring the soft tissue healingperiod combined with implant.This product should be removedwhen the superstructure is setup. | Implantium Prosthetic isintended for use as an aid inprosthetic rehabilitation. |
| Similarities | The subject device has same intended use, functions, material, surface treatment, principle of operation, shelf life and similar design and heights as the primary predicate. | ||
| Differences | There are slightly different diameters between the subject and primary predicate device. K070228 was added to support the large diameters of the subject healing abutments such as 8.0 and 9.0mm. |
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| 4) IS Encoded Healing Abutment | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------- | -- |
| Subject Device | Primary Predicate Device | ReferenceDevice | ReferenceDevice | |
|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Biomet 3i. | DentiumCo., Ltd. |
| DeviceName | IS-III active System | CMI Implant IS System | Implantium Prosthetics | |
| 510(k)Number | K181138 | K113554 | K070228 | |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTMF136 | Titanium Grade 4 of ASTMF67 | |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design | Image: Reference Device Design | |
| Diameters(Ø) | Body:4.0/4.6/5.3/5.8/6.6/8.0/9.0 | 4.8/5.5/6.0/6.8 | 4.0/4.5/5.5/6.5/7.5/8.5/9.5 | |
| Lengths(mm) | Body Cuff: 2.3/3.3/4.3/5.3/6.3/7.3 | 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 | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | |
| Principle ofOperation | This product is healing Abutmentto formation appropriate gingivalshape during the soft tissue healingperiod combined with implant.This product should be removedwhen the superstructure is set up.It is two-piece type which isconsist with Healing Abutmentand Abutment screw.The occlusal surface of the deviceincludes machined markings thatprovide information about themating implant's positionand orientation. | This product is healingAbutment to formationappropriate gingival shapeduring the soft tissuehealing period combinedwith implant. This productshould be removed when thesuperstructure is set up. | Implantium Prosthetic isintended for use as an aid inprosthetic rehabilitation. | |
| Similarities | The subject device has same intended use, material, function, surface treatment, principle ofoperation and similar dimensions as the primary predicate. | |||
| Differences | There are slightly different dimensions. To support diameters, K070228 was added and to supportheights, K070228 were added. |
5) IS Solid Abutment
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
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| Design | |
|---|---|
| Image: dental implant design | Image: dental implant design with length and cuff labels |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 |
| Lengths(mm) | 4.0/4.5/5.5/7.0 |
| Lengths(mm) | 4.5/5.5/6.0/7.0/8.0 |
| SurfaceTreatment | TiN-Coating |
| SurfaceTreatment | TiN-Coating |
| Principle ofOperation | It is one body cement retained restoration, connected with fixture and cemented crown on the Abutment. |
| Principle ofOperation | It is one body cement retained restoration, connected with fixture and cemented crown on the Abutment. |
| Similarities | The subject device has same intended use, material, function, surface treatment, principle of operation and similar design and dimensions. |
| Differences | The dimensions are slightly different but it doesn't affect device's fundamental functions. |
6) Protective Cap
| Subject Device | Predicate Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Polyoxymethylene (POM) of ASTM F1855 | Polyoxymethylene (POM) of ASTM F1855 |
| Design | Image: Subject Device Design | Image: Predicate Device Design |
| Diameters (Ø) | 5.0/5.7/6.2/7.1 | 4.5/5.2/5.7/6.5 |
| Lengths(mm) | 5.5/6.3/7.3/8.8/7.75/9.25 | 4.5/5.5/6.0/7.0/8.0 |
| SurfaceTreatment | N/A | N/A |
| Principle ofOperation | Used to protect Solid Abutments in the oral cavity | Used to protect Solid Abutments in the oral cavity |
| Similarities | The subject device has same intended use, material, function, principle of operation and similar design and dimensions. | |
| Differences | The dimensions are slightly different but it doesn't affect device's fundamental functions. |
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| 7) IS Cemented Abutment / IS Shapable Abutment/ IS Angled Abutment | |
|---|---|
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Dentium Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System | Dentum Implantium® /SuperLine® Prosthetics |
| 510(k) Number | K181138 | K113554 | K160828 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Pure Titanium Grade4 |
| IS Cemented Abutment | |||
| Design | Image: IS Cemented Abutment Hex Design | Image: IS Cemented Abutment Non-Hex Design | Image: IS Cemented Abutment SCRP Design |
| Hex | Non-Hex | SCRP | |
| Diameters (Ø) | 4.5/5.2/5.7/6.5 | 4.5/5.2/5.7/6.5 | - |
| Lengths(mm) | 4.0/4.5/5.5/7.0/8.0 | 4.5/5.5/6.0/7.0/8.0 | - |
| IS Shapable Abutment | Dual Milling Abutment | ||
| Design | Image: IS Shapable Abutment Hex Design | Image: IS Shapable Abutment Non-Hex Design | Image: Dual Milling Abutment Design |
| Hex | Non-Hex | Hex and Non-Hex | |
| Hand Milling Only | Yes | Yes | |
| Diameters(Ø) | 4.5/5.2/5.7/6.5 | 4.0~6.5 | |
| Lengths(mm) | 8.1/11.1 | 14.7 | |
| IS Angled Abutment | |||
| Design | Image: IS Angled Abutment Hex Design | Image: IS Angled Abutment Non-Hex Design | - |
| Hex | Non-Hex | ||
| Diameters (Ø) | 4.5/5.2/5.7 | 4.5/5.2/5.7/6.5 | - |
| Lengths(mm) | 7.0 | 7.0/8.0 | - |
| Angle (°) | 15/25 | 15/25 | - |
| SurfaceTreatment | TiN-Coating | TiN-Coating | Non-coated |
| Principle ofOperation | It is indicated for screw-retainedsingle tooth or cement retainedsingle tooth and bridgerestorations. | It is indicated for screw-retainedsingle tooth or cement retainedsingle tooth and bridgerestorations. | It is indicated for screw-retained single tooth orcement retained single toothand bridge restorations. |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface treatment,general shape (design) and dimensions as the primary predicate. | ||
| Differences | 11mm of the length of IS Cemented Abutment was added compared to the primary predicate. To supportthe 11mm length, K160828 was added. This addition doesn't affect device's fundamental functions, |
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8) IS Ball Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | ||
| Diameters (Ø) | Ball Abutment: 3.5Housing:5.0 /Retainer:5.0 /O-Ring:4.5/4.7 | Ball Abutment: 3.5Housing:5.0 /Retainer:5.0 /O-Ring:4.6/4.7 |
| Length(mm) | Ball Abutment: 11.1/12.1/13.1/14.1Housing Length:4.0 /Retainer Length:2.0 | Ball Abutment: 11.1/12.1/13.1/14.1Housing Length:4.0 /Retainer Length:2.0 |
| Surface Treatment | N/A | N/A |
| Principle ofOperation | Used for implant retained mucosa-supportedrestorations, such as overdentures where thepatient is fully edentulous in the arch to berestored. | Used for implant retained mucosa-supportedrestorations, such as overdentures where thepatient is fully edentulous in the arch to berestored. |
| Similarities | ||
| Differences | The diameter of the O-ring is slightly different but it is in the range of the predicate device. |
9) IS Gold UCLA Abutment
| Subject Device | Primary Predicate | ||||||
|---|---|---|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | |||||
| Device Name | IS-III active System | CMI Implant IS System | |||||
| 510(k) Number | K181138 | K113554 | |||||
| Material | Gold Alloy/Polyoxymethylene(POM) of ASTM F1855 | Gold Alloy/Polyoxymethylene(POM) of ASTM F1855 | |||||
| Design | Image: [Hex] | Image: [Non-Hex] | Image: [SCRP] | Image: [Hex] | - | - | |
| Hex | Non-Hex | SCRP | Hex | Non-Hex | SCRP | ||
| Diameters (Ø) | 4.5 | 4.5/5.5/6.5 | |||||
| Length(mm) | 10.0 | 10.0 | |||||
| Surface Treatment | N/A | N/A | |||||
| Principle ofOperation | It is used when there are restrictions on theprosthesis production because of path,aesthetics, and space of fixture.Production the prosthesis by casting withdental alloy after wax up with desired shape | It is used when there are restrictions on theprosthesis production because of path,aesthetics, and space of fixture.Production the prosthesis by casting withdental alloy after wax up with desired shape. | |||||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surfacetreatment, general shape (design) and dimensions. | ||||||
| Differences | There is no difference between the subject and primary predicate. |
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10) IS Temporary Abutment
| Subject Device | Primary Predicate | Reference Device | |||||
|---|---|---|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. | Dentium Co., Ltd. | ||||
| Device Name | IS-III active System | CMI Implant IS System | Dentum Implantium® /SuperLine® Prosthetics | ||||
| 510(k)Number | K181138 | K113554 | K160828 | ||||
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Pure Titanium Grade4 | ||||
| Design | Image: Hex design | Image: Non-Hex design | Image: SCRP design | Image: Non-Hex design | Image: Hex/Non-Hex design | ||
| Hex | Non- | SCRP | Hex | Non- | SCRP | Hex/Non-Hex | |
| Diameters (Ø) | 4.5 | 4.5/5.2/5.7/6.5 | 4.5 | ||||
| Length(mm) | 6.0/8.0/11.5 | 6.0/8.0 | 13.7 | ||||
| SurfaceTreatment | N/A | N/A | N/A | ||||
| Principle ofOperation | It is dental Abutmentsdesigned to serve as atemporary dental prosthesisduring the healing processuntil a permanent crown ismade. | It is dental Abutmentsdesigned to serve as atemporary dental prosthesisduring the healing process untila permanent crown is made. | It is dental Abutmentsdesigned to serve as atemporary dental prosthesisduring the healing processuntil a permanent crown ismade | ||||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surfacetreatment, general shape (design) and diameters. | ||||||
| Differences | Lengths of the device are longer than the primary predicates. To support this difference, K160828was added. These differences don't affect device's fundamental functions, safety and effectiveness. |
11) IS Abutment Screw
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd. |
| Device Name | IS-III active System | CMI Implant IS System |
| 510(k) Number | K181138 | K113554 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: screw | Image: screw |
| Diameters (Ø) | 2.3 | 2.3 |
| Length (mm) | 8.8/8.3 | 7.55/9.55 |
| Surface Treatment | N/A | N/A |
| Principle of Operation | This product is a screw for connectedwith Abutment and fixture. | This product is a screw for connected withAbutment and fixture. |
| 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 fundamentalfunctions, safety and effectiveness. |
{14}------------------------------------------------
Similarities:
The IS-III active Fixture has same device characteristics with the Primary predicate devices, CMI Implant IS System (K113554) such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar.
The IS-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. 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-etched) and the surface treatment method of the primary Predicate device is RBM (Resorbable Blasting Media). To support this discrepancy, K120503 was selected as Reference Device for the fixtures and biocompatibility testing was performed on the subject device. The dimensions of various Abutments are slightly different from the predicate devices. However, the dimensions of the subject device are in the range of the dimensions of the primary and reference devices. Therefore, this dimensional difference doesn't affect device safety and effectiveness.
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ● ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- . Fatigue Testing according to ISO 14801:2016 under the worst-case scenario
- . Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP <161>, and USP <85>
- . End User Sterilization Validation Test Report according to ANSVAAMI ST79, ISO 17665-1. ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
- Gamma sterilization validation Test Report according to ISO 11137-1, ISO 11137-2 and ISO 11137-3
- Shelf Life Test according to ASTM F1980, ASTM F1140, ASTM F1140, ASTM F1929, and ● ASTM F2096
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted on the subject fixtures and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device.
Biocompatibility test performed on our previously cleared predicate K113554 can be leveraged for the subject abutments because they are made of same materials and have same manufacturing process.
Fatigue testing for IS-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. The results ensure that the subject device is substantially equivalent.
Sterilization Validation and Shelf Life testing for fixtures and healing abutments was conducted on the predicate devices. Since the materials, manufacturing process, sterilization method, packaging materials
{15}------------------------------------------------
and methods are identical between the subject and predicate devices, the test reports can be leveraged for the subject device.
The shelf life for fixtures and healing abutments are 5 years.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
IS-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, IS-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.