(119 days)
No
The device description and performance studies focus on the mechanical and material properties of a dental implant abutment system, with no mention of AI or ML.
Yes.
Explanation: The device is intended to provide support for prosthetic restorations such as bridges, which is a therapeutic function for dental implants.
No
This device is a multi-unit abutment system used to provide support for prosthetic restorations on dental implants, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it is composed of physical components made of Titanium ELI, such as abutments, cylinders, and screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations (bridges) with a dental implant. This is a mechanical function within the body.
- Device Description: The device is a premanufactured dental implant abutment made of Titanium. It's a physical component used in a surgical procedure and subsequent prosthetic attachment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
- Performance Studies: The performance studies focus on mechanical properties (fatigue), sterilization, shelf-life, and biocompatibility – all relevant to an implantable or surgically used device, not an IVD.
The device is clearly a medical device used in a surgical and restorative dental procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.
IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.
All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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)
The subject device was tested to evaluate its substantial equivalence according to the following standards:
- End User Sterilization Validation Test Report on IS Multi Unit Abutment Angled Abutment ● (Hex type) according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
- . Fatigue Test Report according to ISO 14801:2016
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
- Biocompatibility Test according to ISO 10993-1 referenced in K181138
- Bacterial Endotoxin Testing on Healing Abutments according to ANSI/AAMI ST72:2011, USP ● , and USP , 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K120530, K180282, K181138, K182091, K182194
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K210903
Trade/Device Name: IS Multi Unit Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 21, 2021 Received: April 26, 2021
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 medical devices and radiation-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,
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K210903
Device Name IS Multi Unit Abutment System
Indications for Use (Describe)
IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.
| 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 #204, 36, Digital-ro 27 gil Guro-gu, Seoul, 08381, South Korea Email: sypark@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 Multi Unit Abutment System
- Common Name: Endosseous Dental Implant Abutment
- Classification Name: Abutment, Implant, Dental, Endosseous
- . Product Code: NHA
- Panel: Dental
- Regulation Number: 21 CFR 872.3630
- Device Class: Class II
- Date Prepared: 07/22/2021
Predicate Devices:
Primary Predicate
- K161689, OSSTEM Implant System-Abutment by Osstem Implant Co.,Ltd. .
Reference Devices
- . K120530, DENTIN Dental Implant System by Dentin Implant Technologies Ltd.
- K180282, MIS Internal Hex Dental Implant System by MIS Implant Technologies Ltd.
- K181138, IS-III active System by Neobiotech Co., Ltd.
- K182091, Osstem Abutment System by Osstem Implant Co.,Ltd. ●
- K182194, UV Active Implant System by DIO Corporation ●
Indications for Use:
IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.
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Device Description
IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.
IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.
All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.
| Name | Diameter
(Ø) | Cuff(mm) | Length(mm) | Angulation |
|-------------------------------------|-----------------|-------------------------|------------|------------|
| IS Multi Unit Abutment | Ø 4.8 | 1.0/2.0/3.0/4.0/5.0/6.0 | - | 0° |
| IS Multi Unit Angled Abutment | Ø 4.8 | 1.0/2.0/3.0/4.0 | - | 17°,30° |
| Multi Unit Abutment Cylinder | Ø 4.8 | - | 5.0 | 0° |
| Multi Unit Healing Cap | Ø 4.8 | - | 4.1 | 0° |
| Multi Unit Temporary Cylinder | Ø 4.8/6.0 | - | 11.0 | 0° |
| IS Multi Unit Angled Abutment Screw | Ø2.3 | - | 8.3 | 0° |
| Cylinder Screw | Ø2.3 | - | 4.1 | 0° |
The dimensions of abutments are as following:
The tolerance of dimension shall be within ± 1% range.
| K number | System Name | Diameter (Ø) | Length(mm) |
|---|---|---|---|
| K181138 | IS-III active System | Ø 4.0/4.5/5.0/5.5 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Ø 6.0/7.0 | 7.3/8.5/10.0/11.5/13.0 | ||
| K120503 | CMI Implant IS II active | Ø 4.0/4.5/5.0/5.5/6.0/7.0/8.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
The IS Multi Unit Abutment System is compatible with following implant system:
The features of each abutment are as following:
| Name | Uses | Surface
Treatment | Connection |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------|
| IS Multi Unit Abutment | It is connected with Fixture and it supports | N/A | Screw
Retained |
| IS Multi Unit Angled
Abutment | prosthesis which restores tooth function. | N/A | Hex,
Non-Hex, |
| Multi Unit Abutment Cylinder | It is connected with Multi Unit Abutment
(Straight/Angled) in order to cement final
prosthesis. | N/A | Non-Hex |
| Multi Unit Healing Cap | It is connected with Multi Unit Abutment (Straight/
Angled type) in order to protect Multi Unit
Abutment (Straight/Angled) and inner hole during
the healing period. | N/A | Screw
Retained |
| Multi Unit Temporary
Cylinder | It is connected with Multi Unit Abutment (Straight/
Angled) and it supports prosthesis which restores
tooth function as a temporary dental prosthesis. | N/A | Non-Hex |
| IS Multi Unit Angled
Abutment Screw | It is used to fix Multi Unit Angled Abutment at the
top of Fixture. | N/A | Screw
Retained |
5
| Cylinder Screw | It is used to fix Multi Unit Abutment Cylinder or
Multi Unit Temporary Cylinder at the top of Multi
Unit Abutment (Straight/ Angled). | N/A | Screw
Retained |
| ---------------- | --------------------------------------------------------------------------------------------------------------------------------------------- | ----- | ------------------- |
|---|
Multi Unit Healing Cap is supplied sterile, and intended for singled use. Other Multi Unit components are supplied non sterile, to be steam sterilized by the user according to the labeling, and intended for single use.
IS Multi Unit Angled Abutment, Multi Unit Temporary Cylinder, Multi Unit Abutment Cylinder are provided with IS Multi Unit Abutment Screw or Cylinder Screw in packing.
And IS Multi Unit Abutment and Multi Unit Healing Cap have built in screw as an integral system. All of above products including enclosed product are packed separately for convenience.
Materials:
All subject devices are made of Titanium ELI of ASTM F136.
Summaries of Technological Characteristics: 1) IS Multi Unit Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Company | Neobiotech Co., Ltd | Osstem Implant Co., Ltd. | Dentin Implants Technologies |
| Ltd. | |||
| Device Name | IS Multi Unit Abutment System | OSSTEM Implant System- | |
| Abutment | DENTIN Dental Implant System | ||
| 510(k) Number | K210903 | K161689 | K120530 |
| Classification | |||
| Name | Abutment, Implant, Dental, | ||
| Endosseous | Abutment, Implant, Dental, | ||
| Endosseous | Abutment, Implant, Dental, | ||
| Endosseous | |||
| Product Code | NHA | NHA | NHA |
| Regulation | |||
| Number | 872.3630 | 872.3630 | 872.3630 |
| Intended Use | IS Multi Unit Abutment System | ||
| is intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such as | |||
| bridges. | The OSSTEM Implant System – | ||
| Abutment is intended for use | |||
| with a dental implant to provide | |||
| support for prosthetic | |||
| restorations such as crowns, | |||
| bridges, or overdenture | DENTIN® Dental Implants | ||
| System is indicated for use in | |||
| surgical and restorative | |||
| applications for placement in the | |||
| bone of the upper or lower jaw | |||
| to provide support | |||
| for prosthetic devices, such as | |||
| artificial teeth, in order to restore | |||
| the patient's | |||
| chewing function. DENTIN® | |||
| Dental Implants System is | |||
| indicated also for | |||
| immediate loading when good | |||
| primary stability is achieved and | |||
| with appropriate | |||
| occlusal loading. | |||
| Two Stage Implants: CLASSIC, | |||
| RAPID, PRESTIGE. | |||
| One Stage Implants: ONE | |||
| PIECE | |||
| DENTIN® ONEPIECE Implants | |||
| 3.0 mmd are intended for | |||
| placement at the mandibular | |||
| central and lateral incisors and | |||
| maxillary and lateral incisors. |
6
| | | | Indicated also for denture
stabilization using multiple
implants. |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Design 1 | Image: Design 2 | Image: Design 3 |
| Abutment/Impl
ant Interface
Connection
Type | Internal Non-Hex | Internal Non-Hex | Internal Non-Hex |
| Diameters (Ø) | 4.8 | 4.8 | 5.0 |
| Cuff(mm) | 1.0/2.0/3.0/4.0/5.0/6.0 | 1.0/2.0/3.0/4.0/5.0 | 6.0 |
| Post Height
(mm) | 2.2 | - | - |
| Surface
Treatment | N/A | TiN-Coating | TiN-Coating |
| Sterilization | End-User Moist Heat
Sterilization | - | - |
| Principle of
Operation | It is indicated for cement
retained 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 functions, materials, principle of operation and similar
indications for use, design and dimensions. | | |
| Differences | There are differences in Indications for Use, design, cuff length and surface treatment between the
subject device and primary predicate.
- Indications for Use: The subject device doesn't include the "O-ring" as the component; therefore, it is
not intended to use for overdenture. Also, since the subject devices are only indicated for multi-unit
restorations, it is not intended to use for crowns. As the indications for use of the subject device are in
range of the predicate's, it doesn't affect the substantial equivalence. - Design, Cuff length, and Surface treatment: To support Ø4.8X6.0mm of subject abutment and surface
treatment, K120530 was added as the reference device. These differences don't affect product's
fundamental functions and substantial equivalence. | | |
2) IS Multi Unit Angled Abutment
| Subject Device | Reference Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Dio Corporation |
| Device Name | IS Multi Unit Angled Abutment | UV Active Implant System- |
| Angled Multi-Unit Abutment | ||
| 510(k) Number | K210903 | K182194 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
7
| Design | |||
|---|---|---|---|
| Abutment/Implant | |||
| Interface | |||
| Connection Type | Internal Hex | Internal Non-Hex | Internal Hex |
| Diameters (Ø) | 4.8 | 4.8 | |
| Cuff(mm) | 1.0/2.0/3.0/4.0 | 1.5/2.5/3.5/4.5/5.5 | |
| Post Height(mm) | 2.2 | - | |
| Angle(°) | 17/30 | 20/30 | |
| Surface Treatment | N/A | N/A | |
| Sterilization | End-User Moist Heat Sterilization | - | |
| Principle of | |||
| Operation | It is indicated for cement retained bridge | ||
| restorations. | It is indicated for screw-retained single tooth | ||
| or cement retained single tooth and bridge | |||
| restorations. | |||
| Shelf Life | N/A | N/A | |
| Similarities | The subject and reference devices have same intended use, functions, materials, surface | ||
| treatment, general shape (design) and dimensions. | |||
| Differences | There are slightly different designs and dimensions between subject and reference devices. | ||
| These differences don't affect product's fundamental functions and substantial equivalence. |
3) Multi Unit Abutment Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | MIS Implants Technologies Ltd. |
| Device Name | Multi Unit Abutment Cylinder | Cementing cap for Multi-Unit |
| 510(k) Number | K210903 | K180282 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Multi Unit Abutment Cylinder design | Image: Cementing cap for Multi-Unit design |
| Diameters (Ø) | 4.8 | 4.8 |
| Lengths(mm) | 5.0 | 3.3 |
| Post Height(mm) | 5.0 | 3.3 |
| Surface Treatment | N/A | TiN-Coating |
| Sterilization | End-User Moist Heat Sterilization | Gamma irradiation |
| Principle of | ||
| Operation | It is used to support the prosthesis, and it is | |
| connected with Multi Unit Abutment with | ||
| Cylinder Screw. | It is used to support the prosthesis, and it is | |
| connected with Multi Unit Abutment with | ||
| Cylinder Screw. | ||
| Shelf Life | N/A | 5 years |
| Similarities | The subject and reference devices have same intended use, functions, materials, surface | |
| treatment, general shape (design) and dimensions. | ||
| Differences | There are slightly different design and length. These differences don't affect product's | |
| fundamental functions and substantial equivalence. |
8
4) Multi Unit Healing Cap
| Subject Device | Reference Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | MIS Implants Technologies Ltd. |
| Device Name | Multi Unit Healing Cap | Healing Cap |
| 510(k) | ||
| Number | K210903 | K180282 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters(Ø) | 4.8 | 4.8 |
| Length (mm) | 4.1 | 4.3 |
| Post Height | ||
| (mm) | 4.1 | 4.3 |
| Surface | ||
| Treatment | N/A | TiN-Coating |
| Sterilization | Gamma irradiation | - |
| Principle of | ||
| Operation | It is connected to the dental Abutment during | |
| soft tissue healing period combined with | ||
| Implant. It should be removed when the | ||
| superstructure is set up. | It is connected to the dental Abutment during | |
| soft tissue healing period combined with | ||
| Implant. It should be removed when the | ||
| superstructure is set up. | ||
| Shelf Life | 5 years | 5 years |
| Similarities | The subject and reference devices have same intended use, functions, materials, general shape | |
| (design) and dimensions. | ||
| Differences | There are slightly different design and length. These differences don't affect product's fundamental | |
| functions and substantial equivalence. |
5) Multi Unit Temporary Cylinder
| Subject Device | Reference Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | DIO Corporation |
| Device | ||
| Name | Multi Unit Temporary Cylinder | Temporary Cylinder |
| 510(k) | ||
| Number | K210903 | K182194 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters | ||
| (Ø) | 4.8/6.0 | 5.4 |
| Length | ||
| (mm) | 11.0 | 12.0 |
| Post Height | ||
| (mm) | 11.0 | 12.0 |
| Surface | ||
| Treatment | N/A | N/A |
| Sterilization | End-User Moist Heat Sterilization | - |
| Principle of | ||
| Operation | It is designed to serve as a temporary dental | |
| prosthesis during the healing process until a | ||
| permanent bridges are made. | It is designed to serve as a temporary dental | |
| prosthesis during the healing process until a | ||
| permanent crown is made. | ||
| Shelf Life | N/A | N/A |
9
| Similarities | The subject and reference devices have same intended use, functions, materials, and general shape
(design). |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | There are slightly different design and dimensions. These differences don't affect device's
fundamental functions and substantial equivalence. |
6) IS Multi Unit Angled Abutment Screw
| 6) IS Multi Unit Angled Abutment Screw | ||
|---|---|---|
| Subject Device | Reference Device | |
| Company | Neobiotech Co., Ltd | Dio Coporation |
| Device Name | IS Multi Unit Angled Abutment Screw | Multi Angled Abutment Screw |
| 510(k) | ||
| Number | K210903 | K182194 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters(Ø) | 2.3 | 2.2 |
| Length (mm) | 8.3 | 6.0 |
| Surface | ||
| Treatment | N/A | N/A |
| Sterilization | End-User Moist Heat Sterilization | |
| Principle of | ||
| Operation | This product is a screw for connected with | |
| Abutment and fixture. | This product is a screw for connected with | |
| Abutment and fixture. | ||
| Shelf Life | N/A | N/A |
| Similarities | The subject and reference devices have same intended use, functions, materials, and general shape | |
| (design). | ||
| Differences | There are slightly different design and dimensions. These differences don't affect device's | |
| fundamental functions and substantial equivalence. |
7) Cylinder Screw
| Subject Device | Reference Device | |
|---|---|---|
| Company | Neobiotech Co., Ltd | Dio Coporation |
| Device Name | Cylinder Screw | Cylinder Screw |
| 510(k) Number | K210903 | K182194 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Cylinder Screw | Image: Cylinder Screw |
| Diameters(Ø) | 2.3 | 2.15 |
| Length (mm) | 4.1 | 4.0 |
| Surface Treatment | N/A | N/A |
| Sterilization | End-User Moist Heat Sterilization | - |
| Principle of Operation | This product is a screw for connected with Multi Unit Abutment (Straight/Angled) and Cylinder. | This product is a screw for connected with Multi Unit Abutment (Straight/Angled) and Cylinder. |
| Shelf Life | N/A | N/A |
| Similarities | The subject and reference devices have same intended use, functions, materials, and general shape (design). | |
| Differences | There are slightly different design and dimensions. These differences don't affect device's fundamental functions and substantial equivalence. |
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Similarities:
IS Multi Unit Abutment System has same device characteristics with the Primary predicate devices, OSSTEM Implant System-Abutment (K161689) and commercially available products based on the indications for use, the technology used, 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 standards and US FDA Guidance.
Differences:
There are differences in Indications for Use, design, cuff length and surface treatment between the subject device and primary predicate.
- Indications for Use: The subject device doesn't include the "O-ring" as the component; therefore, it is not intended to use for overdenture. As the indications for use of the subject device are in range of the predicate's, it doesn't affect the substantial equivalence.
- Design, Cuff length, and Surface treatment: To support Ø4.8X6.0mm of subject abutment and surface treatment, K182194 and K120530 were added as the reference device. These differences don't affect product's fundamental functions and substantial equivalence.
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- End User Sterilization Validation Test Report on IS Multi Unit Abutment Angled Abutment ● (Hex type) according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1
- . Fatigue Test Report according to ISO 14801:2016
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
- Biocompatibility Test according to ISO 10993-1 referenced in K181138
- Bacterial Endotoxin Testing on Healing Abutments according to ANSI/AAMI ST72:2011, USP ● , and USP , 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.
Conclusion
IS Multi Unit Abutment 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 Multi Unit Abutment System and its predicates are substantially equivalent.