(135 days)
No
The summary describes a dental implant system and its components, focusing on materials, dimensions, and mechanical properties. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as an implantable fixture and abutments used to restore chewing function by supporting prosthetic devices, which falls under the definition of a therapeutic device.
No
Explanation: The device is an implant system (fixture and abutments) used to replace missing teeth and provide support for prosthetic devices, not to diagnose a condition. Its function is restorative and supportive, not diagnostic.
No
The device description clearly states it is composed of physical components (fixtures and abutments made of Titanium ELI) that are implanted into bone. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the IS-III active System S-narrow Type is a dental implant system designed to be surgically placed in the bone to support prosthetic devices and restore chewing function. It is a physical implant, not a test performed on a sample.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the IS-III active System S-narrow Type is a medical device, specifically a dental implant system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 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.
The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.
IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw
The dimensions of abutments are as following:
| Name | Diameter
(mm) | Platform
diameter (mm) | Length (mm) | Gingiva
Height (mm) | Angulation |
|---|---|---|---|---|---|
| IS Cover Screw_S-Narrow
Type | Ø 3.0 | - | 4.8/5.8/6.4 | 0.4/1.4/2.0 | 0° |
| | Ø 3.0 | 2.61 | 7.4/9.4/11.4 | 3.0/5.0/7.0 | 0° |
| IS Healing Abutment_S-
Narrow Type | Ø 3.8 | | 7.4/9.4/11.4 | | 0° |
| | Ø 4.3 | 2.61 | 7.4/8.4/9.4/ | 3.0/4.0/5.0/ | 0° |
| | | | 11.4/13.4 | 7.0/9.0 | |
| IS Cemented Abutment_S-
Narrow Type | Ø 3.5 | 2.61 | 7.0 | 2.0 | 0° |
| | Ø 4.0 | | 5.5/7.0 | | 0° |
| IS Temporary Abutment_S-
Narrow Type | Ø 3.0 | 2.61 | 14.1/13.5 | 1.5 | 0° |
| IS Abutment Screw_S-
Narrow Type | Ø 2.0 | - | 10.2 | - | 0° |
The features of each abutment are as following:
| Name | Uses | Surface
Treatment | Connection |
|---|---|---|---|
| IS Cover Screw
_S-Narrow Type | It is used for protecting inner hole and connecting
part with exposed upper part of structure during the
healing period after inserting dental implant fixture | N/A | Screw
Retained |
| IS Healing Abutment
_S-Narrow Type | Used to formation appropriate gingival shape
during the soft tissue healing period combined with
implant | N/A | Screw
Retained |
| IS Cemented Abutment
_S-Narrow Type | The Abutment is connected with fixture and it | TiN-Coating | Hex,
Non-Hex |
| IS Temporary Abutment
_S-Narrow Type | supports prosthesis which restores tooth function. | N/A | Hex,
Non-Hex |
| IS Abutment Screw
_S-Narrow Type | It is used to fix Abutment at the top of fixture | N/A | Screw
Retained |
Tolerance of dimension for Abutments shall be within ± 1% range.
The surface of IS Cemented Abutment_S-narrow Type was treated with TiN-Coated.
IS-III active Fixture_S-Narrow type, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized.
IS-III active Fixture_S-Narrow Type is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing.
All of above products including enclosed product are packed separately for convenience.
Materials:
The Fixtures and Abutments are made of Titanium ELI of ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3
- Shelf Life Test on Fixtures according to ASTM F1980
- Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP , . and USP
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Test on Healing Abutments according to ISO 11137-1,2,3 referenced in K181138
- Shelf Life Test on Healing Abutments according to ASTM F1980 referenced in K181138
- 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 referenced in K181138
- 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 referenced in K181178
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on TiN Coated abutments referenced in K181138
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K150537, K161244, K171728, K181138, K181178
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2019
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K190849
Trade/Device Name: IS-III active System S-narrow Type Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 7, 2019 Received: July 15, 2019
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190849
Device Name IS-III active System S-narrow Type
Indications for Use (Describe)
The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The IS-III active System S-narrow Type is indicated also 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) |
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3
510(k) Summary
Submitter
Neobiotech. Co., Ltd. Young-Ku, Heo 10F, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: sakim@neobiotech.co.kr 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 S-narrow Type
- Common Name: Endosseous dental implant
- Classification Name: Endosseous dental implant ●
- Primary Product Code: DZE ●
- Secondary Product Code: NHA ●
- Panel: Dental
- Regulation Number: 21 CFR 872.3640 ●
- Device Class: Class II
- Date Prepared: 08/13/2019 ●
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
K130462, Paltop Narrow Implant manufactured by Paltop Advanced Dental Solutions Ltd. .
Reference Devices -
K150537, MiNi Internal Implant System by Megagen Implant Co., Ltd. ●
-
K161244, s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. ●
-
K171728, MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1 x 18mm and 2.4x18mm ● by Sterngold Dental, LLC.
-
K181138, IS-III active System by Neobiotech Co., Ltd. ●
-
K181178. S-mini active Fixture by Neobiotech Co., Ltd. ●
Indications for Use:
The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
4
Device Description
IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 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.
The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.
IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw
| Name | Diameter
(mm) | Platform
diameter (mm) | Length (mm) | Gingiva
Height (mm) | Angulation |
|-----------------------------------------|------------------|---------------------------|--------------|------------------------|------------|
| IS Cover Screw_S-Narrow
Type | Ø 3.0 | - | 4.8/5.8/6.4 | 0.4/1.4/2.0 | 0° |
| | Ø 3.0 | 2.61 | 7.4/9.4/11.4 | 3.0/5.0/7.0 | 0° |
| IS Healing Abutment_S-
Narrow Type | Ø 3.8 | | 7.4/9.4/11.4 | | 0° |
| | Ø 4.3 | 2.61 | 7.4/8.4/9.4/ | 3.0/4.0/5.0/ | 0° |
| | | | 11.4/13.4 | 7.0/9.0 | |
| IS Cemented Abutment_S-
Narrow Type | Ø 3.5 | 2.61 | 7.0 | 2.0 | 0° |
| | Ø 4.0 | | 5.5/7.0 | | 0° |
| IS Temporary Abutment_S-
Narrow Type | Ø 3.0 | 2.61 | 14.1/13.5 | 1.5 | 0° |
| IS Abutment Screw_S-
Narrow Type | Ø 2.0 | - | 10.2 | - | 0° |
The dimensions of abutments are as following:
The features of each abutment are as following:
| Name | Uses | Surface
Treatment | Connection |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------|
| IS Cover Screw
_S-Narrow Type | It is used for protecting inner hole and connecting
part with exposed upper part of structure during the
healing period after inserting dental implant fixture | N/A | Screw
Retained |
| IS Healing Abutment
_S-Narrow Type | Used to formation appropriate gingival shape
during the soft tissue healing period combined with
implant | N/A | Screw
Retained |
| IS Cemented Abutment
_S-Narrow Type | The Abutment is connected with fixture and it | TiN-Coating | Hex,
Non-Hex |
| IS Temporary Abutment
_S-Narrow Type | supports prosthesis which restores tooth function. | N/A | Hex,
Non-Hex |
| IS Abutment Screw
_S-Narrow Type | It is used to fix Abutment at the top of fixture | N/A | Screw
Retained |
5
Tolerance of dimension for Abutments shall be within ± 1% range.
The surface of IS Cemented Abutment_S-narrow Type was treated with TiN-Coated.
IS-III active Fixture_S-Narrow type, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized.
IS-III active Fixture_S-Narrow Type is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing.
All of above products including enclosed product are packed separately for convenience.
Materials:
The Fixtures and Abutments are made of Titanium ELI of ASTM F136.
6
Summaries of Technological Characteristics:
1) IS-III active Fixture_S-Narrow
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | Paltop Advanced Dental | ||
| Solutions Ltd. | Neobiotech Co., Ltd. | Sterngold Dental, LLC | ||
| Device | ||||
| Name | IS-III active System_ | |||
| S-Narrow Type | Paltop Narrow Implant | S-mini active Fixture | MOR 3.0mm and PUR NP 3.2mm Implant Systems, | |
| MOR 2.1 x 18mm and 2.4x18mm | ||||
| 510(k) | ||||
| Number | N/A | K130462 | K181178 | K171728 |
| Device | ||||
| Classification | ||||
| Name | Implant, Endosseous, | |||
| Root-Form | Implant, Endosseous, | |||
| Root-Form | Implant, Endosseous, | |||
| Root-Form | Implant, Endosseous, Root-Form | |||
| Product | ||||
| Code | DZE, NHA | DZE, NHA | DZE | DZE, NHA |
| Regulation | ||||
| Number | 872.3640 | 872.3640 | 872.3640 | 872.3640 |
| Intended | ||||
| Use | The IS-III active | |||
| System S-narrow Type is | ||||
| indicated for use in | ||||
| surgical and restorative | ||||
| applications for placement | ||||
| in the mandibular central, | ||||
| lateral incisor and | ||||
| maxillary lateral incisor | ||||
| regions of partially | ||||
| edentulous jaws where the | ||||
| horizontal space is limited | ||||
| by the adjacent teeth and | ||||
| roots, to provide support | ||||
| for prosthetic devices, | ||||
| such as artificial teeth, in | ||||
| order to restore the | ||||
| patient's chewing | ||||
| function. | ||||
| The IS-III active | ||||
| System S-narrow Type is | The Paltop Narrow | |||
| Implant is indicated for | ||||
| use in surgical and | ||||
| restorative applications | ||||
| for placement in the | ||||
| mandibular central, | ||||
| lateral incisor and | ||||
| maxillary lateral incisor | ||||
| regions of partially | ||||
| edentulous jaws where | ||||
| the horizontal space is | ||||
| limited by the adjacent | ||||
| teeth and roots, to | ||||
| provide support for | ||||
| prosthetic devices, such | ||||
| as artificial | ||||
| teeth, in order to restore | ||||
| the patient's chewing | ||||
| function. The Paltop | ||||
| Narrow Implant is | The S-mini active | |||
| Fixture is indicated | ||||
| for use in the | ||||
| treatment of missing | ||||
| maxillary lateral | ||||
| incisors or the | ||||
| mandibular central | ||||
| and lateral incisors to | ||||
| serve as temporary | ||||
| support prosthetic | ||||
| devices during the | ||||
| healing phase of | ||||
| permanent | ||||
| endosseous dental | ||||
| implant, such as | ||||
| artificial teeth, in | ||||
| order to restore | ||||
| chewing function in | ||||
| partially edentulous | ||||
| patients. | The MORTM implants are intended to be used for oral | |||
| rehabilitation of edentulous and partially dentate patients | ||||
| in the maxilla and mandible to support single unit, and | ||||
| multiple unit restorations. Implant retained restorations | ||||
| may consist of single crowns or bridges as well as | ||||
| complete or partial dentures. These implants are intended | ||||
| for delayed loading. Immediate loading is indicated when | ||||
| there is good primary stability and an appropriate | ||||
| occlusal load. The MORTM implants are only intended for | ||||
| use with straight abutments. The implant body is intended | ||||
| to be placed such no angle correction is necessary. | ||||
| The PUR Implants are intended to be used for oral | ||||
| rehabilitation of edentulous and partially dentate patients | ||||
| in the maxilla and mandible to support single unit, and | ||||
| multiple unit restorations. Implant retained restorations | ||||
| may consist of single crowns or bridges as well as | ||||
| complete or partial dentures. These implants are intended | ||||
| indicated also for | ||||
| immediate loading when | ||||
| good primary stability is | ||||
| achieved and with | ||||
| appropriate occlusal | ||||
| loading. | indicated also for | |||
| immediate loading when | ||||
| good primary stability is | ||||
| achieved and with | ||||
| appropriate occlusal | ||||
| loading. | for delayed loading. Immediate loading is indicated when | |||
| there is good primary stability and an appropriate | ||||
| occlusal load. The PUR implants are only intended for | ||||
| use with straight abutments. The implant body is intended | ||||
| to be placed such no angle correction is necessary. | ||||
| Material | Titanium ELI of ASTM F136 | Titanium ELI of ASTM F136 | Titanium ELI of ASTM F136 | Titanium ELI of ASTM F136 |
| Design | Image: Implant Design | Image: Implant Design | Image: Implant Design | Image: (PUR Implant) |
| Anti-Rotational | ||||
| Feature | Internal Hex | Internal Hex | - | Internal Hex |
| Diameters( | ||||
| $Ø$ ) | 3.2 | 3.25 | 2.5/3.0/3.5 | 3.2 |
| Lengths(mm) | 8.5/10.0/11.5/13.0/15.0 | 10.0/11.5/13.0/16.0 | 7.0/8.5/10.0/11.5/13.0/15.0 | 8/10/12/14 |
| Surface | ||||
| Treatment | SLA | SLA | SLA | Roughened-blasted and acid etched |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of | ||||
| Operation | This product is a root-type | |||
| fixture which is inserted | ||||
| in the alveolar bone. It | ||||
| replaces the functions of | ||||
| the missing teeth as a | ||||
| dental implant fixture. | This product is a root-type | |||
| fixture which is inserted | ||||
| in the alveolar bone. It | ||||
| replaces the functions of | ||||
| the missing teeth as a | ||||
| dental implant fixture | This product is a | |||
| root-type fixture | ||||
| which is inserted in | ||||
| the alveolar bone. It | ||||
| replaces the functions | ||||
| of the missing teeth | ||||
| as a dental implant | ||||
| fixture. | This product is a root-type fixture which is inserted in the | |||
| alveolar bone. It replaces the functions of the missing | ||||
| teeth as a dental implant fixture. | ||||
| Shelf Life | 5 Years | 5 Years | ||
| Similarities | The IS-III active Fixture_S-Narrow Type has same device characteristics with the Primary predicate devices, Paltop Narrow Implant | |||
| (K130462) such as diameters, Length, intended use, material, functions, general shape (Design), structure and applied production method | ||||
| are similar. | ||||
| Differences | 8.5mm length of the device are smaller than the primary predicates. To support this discrepancy, K171728 was added as a reference device | |||
| that includes an implant-abutment combination ( $Ø$ 3.2mm X 8.0mm) that meets or exceeds the one ( $Ø$ 3.2mm X 8.5mm) proposed in this | ||||
| submission. |
7
8
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd |
| Device Name | IS-III active System_ | |
| S-Narrow Type | IS-III active System | |
| 510(k) Number | N/A | K181138 |
| Material | Ti-6Al-4V ELI of | |
| ASTM F136 | Ti-6Al-4V ELI of | |
| ASTM F136 | ||
| Design | Image: design of subject device | Image: design of primary predicate |
| Diameters(Ø) | $3.0$ | $3.45$ |
| Lengths(mm) | 4.8/5.8/6.4 | 5.85/6.85/7.45 |
| Surface | ||
| Treatment | N/A | N/A |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle of | ||
| Operation | It is used for protecting inner hole and | |
| connecting part with exposed upper part of | ||
| structure during the healing period after | ||
| inserting dental implant fixture. When | ||
| inserting the Abutment, Cover screw is | ||
| removed. | It is used for protecting inner hole and | |
| connecting part with exposed upper part of | ||
| structure during the healing period after | ||
| inserting dental implant fixture. When | ||
| inserting the Abutment, Cover screw is | ||
| removed. | ||
| Shelf Life | 5 Years | 5 Years |
| Similarities | The subject device has same designs, intended use, material, functions, principle of operation, | |
| shelf life and similar design and dimensions. | ||
| Differences | There are slightly different dimensions. |
2) IS Cover Screw_S-Narrow
3) IS Healing Abutment_S-Narrow
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd |
| Device Name | IS-III active System | |
| S-Narrow Type | IS-III active System | |
| 510(k) | ||
| Number | N/A | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design |
| Diameters(Ø) | 3.0/3.8/4.3 | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 |
| Cuff(mm) | 3.0/5.0/7.0 | 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8/ |
| Surface | ||
| Treatment | N/A | N/A |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
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| Principle of Operation | This product is healing Abutment to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. | This product is healing Abutment to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. |
|---|---|---|
| Shelf Life | 5 Years | 5 Years |
| Similarities | The subject device has same intended use, functions, material, surface treatment, principle of operation, shelf life and similar design and dimensions. |
4) IS Cemented Abutment_S-Narrow
| Subject Device | Primary Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd | MegaGen Implant Co., Ltd. |
| Device Name | IS-III active System_ | ||
| S-Narrow Type | IS-III active System | MiNi Internal Implant System | |
| 510(k) Number | N/A | K181138 | K150537 |
| Material | Ti-6Al-4V ELI of ASTM | ||
| F136 | Ti-6Al-4V ELI of ASTM | ||
| F136 | Ti-6Al-4V ELI of ASTM F136 | ||
| Design | Image: Subject Device Design Hex and Non-Hex | Image: Primary Predicate Device Design Hex and Non-Hex | Image: Reference Predicate Device Design |
| Hex | |||
| Non-Hex | Hex | ||
| Non-Hex | |||
| Diameters(Ø) | 3.5/4.0 | 4.5/5.2/5.7/6.5 | 3.5 |
| Lengths(mm) | 5.5/7.0 | 4.0/4.5/5.5/7.0/8.0 | 5.0/7.0 |
| Surface | |||
| Treatment | TiN-Coating | TiN-Coating | TiN-Coating |
| Sterilization | N/A | N/A | N/A |
| Principle of | |||
| Operation | It is indicated for screw- | ||
| retained single tooth or | |||
| cement retained single tooth | |||
| and bridge restorations. | It is indicated for screw- | ||
| retained single tooth or | |||
| cement retained single tooth | |||
| and bridge restorations. | It is indicated for screw- | ||
| retained single tooth or cement | |||
| retained single tooth and bridge | |||
| restorations. | |||
| Shelf Life | N/A | N/A | N/A |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface | ||
| treatment, general shape (design) and dimensions. | |||
| Differences | There are slightly different designs and dimensions. |
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| Subject Device | Reference Predicate Device | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | MegaGen Implant Co., Ltd. | Neobiotech Co., Ltd |
| Device Name | IS-III active System_ | ||
| S-Narrow Type | MiNi Internal Implant System | IS-III active System | |
| 510(k) | |||
| Number | N/A | K150537 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Hex Design | ||
| Image: Non-Hex Design | Image: Design | Image: Hex Design | |
| Image: Non-Hex Design | |||
| Hex | Hex | ||
| Non-Hex | Non-Hex | ||
| Diameters(Ø) | 3.0 | 3.0 | 4.5 |
| Length(mm) | 14.1/13.5 | 12.0 | 11.1/13.1 |
| Surface | |||
| Treatment | N/A | N/A | N/A |
| Sterilization | N/A | N/A | N/A |
| Principle of | |||
| Operation | It is dental Abutments | ||
| designed to serve as a | |||
| temporary dental prosthesis | |||
| during the healing process until | |||
| a permanent crown is made. | It is dental Abutments | ||
| designed to serve as a | |||
| temporary dental prosthesis | |||
| during the healing process until | |||
| a permanent crown is made. | It is dental Abutments designed | ||
| to serve as a temporary dental | |||
| prosthesis during the healing | |||
| process until a permanent | |||
| crown is made. | |||
| Shelf Life | N/A | N/A | N/A |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface | ||
| treatment, general shape (design) and diameters. | |||
| Differences | Lengths of the device are longer than the primary predicates. |
5) IS Temporary Abutment_S-Narrow
6) IS Abutment Screw_S-Narrow
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Neobiotech Co., Ltd | Dentis Co., Ltd |
| Device Name | IS-III active System_ | ||
| S-Narrow Type | IS-III active System | s-Clean OneQ-SL Narrow | |
| Implant System | |||
| 510(k) | |||
| Number | N/A | K181138 | K161244 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Primary Predicate Design | Image: Reference Device Design |
| Diameters(Ø) | 2.0 | 2.3 | 2.03 |
| Length (mm) | 10.2 | 8.8 | 9.0 |
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| Surface
| Treatment | N/A | N/A | N/A |
|---|---|---|---|
| Sterilization | N/A | N/A | N/A |
| Principle of | |||
| Operation | This product is a screw for | ||
| connected with Abutment and | |||
| fixture. | This product is a screw for | ||
| connected with Abutment and | |||
| fixture. | This product is a screw for | ||
| connected with Abutment and | |||
| fixture. | |||
| Shelf Life | N/A | N/A | N/A |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface | ||
| treatment, general shape (design) and diameters. | |||
| Differences | Length of the device are longer than the primary predicates. |
Similarities:
The IS-III active Fixture S-Narrow Type has same device characteristics with the Primary predicate devices, Paltop Narrow Implant (K130462) such as diameters, Length, intended use, general shape (Design), structure, fundamental technologies and applied production method are similar. The IS-III active Abutments_S-Narrow Type 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 length. 8.5mm length of the device are smaller than the primary predicates. To support this discrepancy, K171728 was added as a reference device that includes an implant-abutment combination (Ø3.2mm X 8.0mm) that meets or exceeds the one (Ø3.2mm X 8.5mm) proposed in this submission.
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 ●
- Shelf Life Test on Fixtures according to ASTM F1980
- Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP , . and USP
Below tests were performed for predicate devices and leveraged for the subject device:
- Sterilization Validation Test on Healing Abutments according to ISO 11137-1,2,3 referenced in K181138
- Shelf Life Test on Healing Abutments according to ASTM F1980 referenced in K181138
- 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 referenced in K181138
- 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 referenced in K181178
- Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, ● and ISO 10993-10:2010 on TiN Coated abutments referenced in K181138
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The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
IS-III active System_S-Narrow Type 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_S-Narrow Type and its predicates are substantially equivalent.