(262 days)
No
The document describes a physical dental implant and its material properties and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a dental implant intended to replace missing teeth and support restorations. This directly addresses health issues (missing teeth) and improves patient function, classifying it as a therapeutic device.
No
The device description clearly states its purpose: "IS-III active Short Implant is a thread type implant made of pure titanium...which will be placed in the alveolar bone to replace the function of the missing tooth." This describes a therapeutic device, not one used for diagnosis.
No
The device description clearly states it is a physical implant made of pure titanium, intended to be placed in bone. The performance studies focus on physical properties, biocompatibility, and sterilization, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description: The provided text describes a dental implant, which is a device surgically placed into the bone to support a prosthesis. This is an implantable medical device, not a device used to examine specimens outside the body.
- Intended Use: The intended use is to support dental restorations in the mouth, which is a direct interaction with the human body, not an in vitro examination of specimens.
The information provided clearly indicates this is a dental implant for surgical placement, which falls under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
IS-III active Short Implants are 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 final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed loading.
Product codes
DZE
Device Description
IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, 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). The Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.
The subject devices are compatible with the following Prosthesis made by Neobiotech Co., Ltd.
IS-III active Short Implant can be enclosed with IS Cover Screw cleared in K181138 in a packing or can be packed separately for convenience. IS-III active Short Implant is provided in sterilized by gamma rays, and valid for 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae, molar region
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:
- Fatigue Testing according to ISO 14801:2016 under the worst-case scenario
- Surface area comparison analysis
- Axial Pull-Out testing according to ASTM F 543-17 A.3
Tests performed for predicate device, K181138 and leveraged for the subject device:
- 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
- Gamma sterilization validation Test Report according to ISO 11137-1, ISO 11137-2 and ISO 11137-3
- Shelf Life Test on Fixtures according to ASTM F 1980
- Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP , and USP
Surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided.
Sterilization and Shelf Life Testing: A sterility assurance level (SAL) of 10^-6 has been validated in accordance with ISO 11137-1:2006. Shelf Life Testing was performed in accordance with ASTM F1980. The shelf life for devices provided sterile is 5 years.
Biocompatibility Testing: Conducted on reference device K181138 and leveraged for the subject device due to same material and manufacturing process, demonstrating biocompatibility.
Surface area Analysis: Evaluated for full external area and for bone resorption of 3mm before surface treatment for subject device and predicate device K121585. Results showed substantial equivalence.
Comparative Bone to Implant Contact Surface Area Analysis: Analyzed for both subject and predicate device K121585 under worst-case implant.
Fatigue Testing: Newly performed according to the FDA guidance document "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. Results showed substantial equivalence under the worst-case scenario.
Axial Pull-Out Testing: Newly performed according to ASTM F543-17 A3. Results showed substantial equivalence under the worst-case scenario.
MR Environment Condition: Non-clinical worst-case MRI review performed using scientific rationale and published literature. Rationale addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
Key results: The results of the non-clinical tests have met the standards and demonstrated the substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
March 28, 2024
Re: K232049
Trade/Device Name: IS-III active Short Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 29, 2024 Received: February 29, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 -S
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
3
Indications for Use
510(k) Number (if known) K232049
Device Name IS-III active Short Implant
Indications for Use (Describe)
IS-III active Short Implants are 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 final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed 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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4
510(k) Summary
Submitter
Neobiotech. Co., Ltd. Young-Ku, Heo #10F, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: yujin.choi@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 Short Implant ●
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Endosseous, Root-Form ●
- . Primary Product Code: DZE
- Panel: Dental ●
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II ●
- Date Prepared: 03/28/2024
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
-
K121585, TS Implant System manufactured by OSSTEM Implant Co., Ltd. ●
Reference Devices -
. K181138, IS-III active System by Neobiotech Co., Ltd.
-
K103089, MIS Short Implants by MIS implants Technologies Ltd. ●
-
K221866, S-Plant Dental Implant System by IDIS Co., Ltd.
Indications for Use:
IS-III active Short Implants are 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 final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed loading.
Device Description
IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, 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.
5
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.
The dimensions are as following:
| Name | Fixture Type | Diameter (mm) | Length (mm) | Material |
|---|---|---|---|---|
| IS-III active Short | ||||
| Implant | Image: Fixture Type | Ø 5.0/5.5/6.0 | 6.6 | TI CP4 |
| (ASTM F67) |
| 510(K) | Abutment Name | Diameter(Ø) | Length or Cuff(mm) |
|---|---|---|---|
| K181138 | IS Cover Screw | 3.6 | 6.4 |
| IS Healing Abutment | 4.0/4.5 4.8/5.5/6.0/ | ||
| 6.8/8.0/9.0 | Cuff: | ||
| 2.1/2.3/2.8/3.3/ | |||
| 3.8/4.1/4.3/4.8/5.3/ | |||
| 5.8/6.1/6.3/6.8/7.8/ | |||
| 8.1/8.8/10.1 | |||
| IS Encoded Healing Abutment | 4.0/4.6/5.3/5.8/6.6/8.0/9.0 | Cuff: 2.3/3.3/4.3/5.3/6.3/7.3 | |
| IS Encoded Healing Abutment Screw | Screw: 2.3 | Screw: | |
| 8.4/9.4/10.4/11.4/12.4/13.4 | |||
| IS Solid Abutment | 4.5/5.2/5.7/6.5 | 4.0/4.5/5.5/7.0 | |
| IS Cemented Abutment | 4.5/5.2/5.7/6.5 | 4.0/4.5/5.5/7.0/8.0 | |
| IS Shapable Abutment | 4.5/5.2/5.7/6.5 | 8.1/11.1 | |
| IS Angled Abutment | 4.5/5.2/5.7 | ||
| Angle (°): 15/25 | 7.0 | ||
| IS Ball Abutment | 3.5 | 11.1/12.1/13.1/14.1/15.1/16.1 | |
| IS Ball Abutment_Component | Housing:5.0 | ||
| Retainer:5.0 | |||
| O-Ring:4.6/4.7 | Housing:4.0 | ||
| Retainer:2.0 | |||
| O-Ring: - | |||
| IS Gold UCLA Abutment | 4.5 | 10.0 | |
| IS Temporary Abutment | 4.5/5.2 | 6.0/8.0/11.5 | |
| Protective Cap | 5.0/5.7/6.2/7.1 | 5.5/6.3/7.3/8.8/7.75/9.25 | |
| IS Abutment Screw | 2.3 | 8.8/8.3 |
The subject devices are compatible with the following Prosthesis made by Neobiotech Co., Ltd.
IS-III active Short Implant can be enclosed with IS Cover Screw cleared in K181138 in a packing or can be packed separately for convenience. IS-III active Short Implant is provided in sterilized by gamma rays, and valid for 5 years.
6
Summaries of Technological Characteristics:
IS-III active Short Implant is similar to other commercially available products based on the intended use, the claims, the material composition employed and performance characteristics.
| Subject Device | Primary Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Company | Neobiotech Co., Ltd | OSSTEM Implant Co., Ltd. | MIS implants Technologies | IDIS Co., Ltd. |
| Device Name | IS-III active Short Implant | TS Implant System | MIS Short Implants | S-Plant Dental Implant System |
| 510(k) Number | N/A | K121585 | K103089 | K221866 |
| Device | ||||
| Classification | ||||
| Name | Implant, Endosseous, | |||
| Root-Form | Implant, Endosseous, | |||
| Root-Form | Implant, Endosseous, Root-Form | Implant, Endosseous, Root-Form | ||
| Product Code | DZE | DZE, NHA | DZE | DZE, NHA |
| Regulation | ||||
| Number | 872.3640 | 872.3640 | 872.3640 | 372.3640 |
| Indications for | ||||
| Use | IS-III active Short Implants are | |||
| indicated for use in partially or | ||||
| fully edentulous mandibles and | ||||
| maxillae, in support of single or | ||||
| multiple-unit restorations | ||||
| including: cemented retained, | ||||
| screw retained, or overdenture | ||||
| restorations, and final or | ||||
| temporary abutment support for | ||||
| fixed bridgework. The IS-III | ||||
| active Short Implants are | ||||
| indicated for the molar region | ||||
| with delayed loading. | The TS Implant System is indicated | |||
| for use in partially or fully | ||||
| edentulous mandibles and maxillae, | ||||
| in support of single or multiple-unit | ||||
| restorations including: cemented | ||||
| retained, screw retained, or | ||||
| overdenture restorations, and final | ||||
| or temporary abutment support for | ||||
| fixed bridgework. It is intended for | ||||
| delayed loading. The abutment is | ||||
| intended for use with a dental | ||||
| implant fixture to provide support | ||||
| for prosthetic restorations such as | ||||
| crowns, bridges, or overdenture. | MIS dental implants are 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. | ||||
| When a one stage surgical | ||||
| procedure is applied, the implant | ||||
| may be immediately loaded when | ||||
| good primary stability is achieved | ||||
| and the occlusal load is appropriate. | ||||
| MIS short implants are to be used | ||||
| only with straight abutments. | The S-Plant Dental Implant System is | |||
| indicated for surgical placement in the | ||||
| upper and lower jaw arches, to provide a | ||||
| root form means for single or multiple | ||||
| units' prosthetic attachment to restore a | ||||
| patient's chewing function. The smaller | ||||
| SPlant Dental Implants (Ø3.4, 3.6, 3.8, | ||||
| 4.2, 4.7, 5.2 mm) can be placed with a | ||||
| conventional two stage surgical process | ||||
| with an option for transmucosal healing | ||||
| or they can be placed in a single stage | ||||
| surgical process for immediate loading | ||||
| when good primary stability is achieved | ||||
| with appropriate occlusal loading. The | ||||
| larger S-Plant Dental Implants (Ø6.0, 7.0 | ||||
| mm) can be placed with a conventional | ||||
| two stage surgical process with an option | ||||
| for transmucosal healing and are | ||||
| indicated for the molar region with | ||||
| delayed loading. | ||||
| Dual abutments are intended for use with | ||||
| a dental implant to provide support for | ||||
| prosthetic restorations such as crowns, | ||||
| bridges, or overdentures. Healing | ||||
| abutments are used to make a natural soft | ||||
| tissue shape before setting up prosthetics | ||||
| and removing cover screw after | ||||
| osseointegration. Cover Screws are used | ||||
| to protect the internal portion of the | ||||
| implant, preventing soft tissue growth | ||||
| into the implant, facilitating provisional | ||||
| restorations when necessary, and enabling | ||||
| the transition to final restoration | ||||
| components once osseointegration is | ||||
| complete. | ||||
| Material | Titanium Grade 4 of ASTM | |||
| F67 | Titanium Grade 4 of ASTM F67 | Ti-6Al-4V ELI of | ||
| ASTM F136 | Titanium Grade 4 of ASTM F67 | |||
| Design | Image: dental implant | Image: dental implant | Image: dental implant | - |
| Structure | - Internal Hex |
- Submerge Type
- Tapered body shape
- Cutting edge for self-tapping | - Internal Hex
- Submerge Type
- Tapered body shape
- Cutting edge for self-tapping | Internal Hex | - |
| Dimension | Ø5.0/5.5/6.0 X 6.6mm | Ø5.1/5.95/6.8 X 6.2mm | Ø 4.2/5.0/6.0 X 6.0mm | Ø 6.0 x 7.0, 8.5, 10.0, 11.5 mm |
| Lengths(mm) | Total Length (mm): 6.6
Implantable Length (mm): 6.6
Threaded length (mm): 6.6 | Total Length (mm): 6.2
Implantable Length (mm): 6.2
Threaded length (mm): 6.2 | 6.0 | - |
| Surface
Treatment | Sand blasting & Acid Etching | Sand blasting & Acid Etching | Sand blasting & Acid Etching | Sand blasting & Acid Etching |
| 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 | 8 Years | 8 Years | - |
| Compatible
Abutments | Straight and angled abutments | Straight and angled abutments | Straight abutment only | - |
7
8
| Similarities | The IS-III active Short Implants have same device characteristics with the Primary devices, TS Implant System (K121585) such as the intended use, material, functions, general shape (Design), connection type, structure and applied production method are similar. |
|---|---|
| The differences between the subject device and the primary device, TS Implant System (K121585) are the indications for Use, diameter, and length. The subject device short implants are compatible with own previously cleared reference device abutments in K181138. The range of diameter of the subject devices is wider and smaller than the primary Device. To support the smaller diameter, Reference Device, MIS Short Implants(K103089) have additionally been provided. | |
| Differences | The total lengths of the subject short implant devices are longer than the identified primary predicate device, K121585. To support the differences in diameter, bench testing of bone to implant contact surface area analysis, comparative surface area analysis, and pull-out testing, were performed to demonstrate the substantial equivalence of implantable surface areas with the identified primary predicate device K121585. The proposed implant body dimensions for 6.0mm diameter are supported by the reference device K221866. Therefore, these differences do not impact substantial equivalence. |
9
Non-clinical testing data:
Below tests were performed on subject device:
- Fatigue Testing according to ISO 14801:2016 under the worst-case scenario ●
- . Surface area comparison analysis
- . Axial Pull-Out testing according to ASTM F 543-17 A.3
Below tests were performed for predicate device, K181138 and leveraged for the subject device:
- 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
- . Gamma sterilization validation Test Report according to ISO 11137-1, ISO 11137-2 and ISO 11137-3
- Shelf Life Test on Fixtures according to ASTM F 1980
- Bacterial Endotoxin Test Report on Fixtures according to ANSVAAMI ST72:2011, USP , and USP
The surface modification information such as surface roughness, surface composition analysis, and SEM imaging with SLA (Sandblasted with Large-grit and Acid-etching) for fixtures was provided.
Sterilization and Shelf Life Testing
For devices provided sterile, a sterility assurance level (SAL) of 10 6 have been validated in accordance with ISO 11137-1:2006. Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Shelf Life Testing was performed in accordance with ASTM F1980, Standard Guide for Accelerated Aging of Sterile Medical Device Packages. The worst-case construct was tested, and results demonstrated equivalence to the predicate devices. The shelf life for devices provided sterile is 5 years.
Biocompatibility Testing
The Biocompatibility Test was conducted on the reference device, K181138 and leveraged for the subject device because both products are manufactured with the same material and manufacturing process. It demonstrates that the subject device is biocompatible and substantial equivalence with the predicate.
Surface area Analysis
Surface area for full external area and for bone resorption of 3mm before surface treatment have been evaluated for subject device and the predicate device, TS Implant System by OSSTEM Implant Co., Ltd. (K121585) under the worst-case implant. And the subject device has the same material as the cleared previous device, which is consist of Pure Titanium. And the subject device and the predicate device are applied to same ASTM standard in accordance with ASTM F 67. Results showed that subject devices are substantially equivalent.
Comparative Bone to Implant Contact Surface Area Analysis
Contact surface area was analyzed in comparison to both subject device and predicate device, K121585, under worst case implant.
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Fatigue Testing
Due to the length of the subject devices, Dynamic fatigue tests were newly performed to demonstrate the mechanical value as compared to the predicate devices, TS Implant System by OSSTEM Implant Co., Ltd. (K121585) according to the FDA guidance document "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. The Results of fatigue testing showed that subject devices are substantially equivalent under the worst-case scenario.
Axial Pull-Out Testing
Due to the length of the subject devices, Pull-out tests were newly performed to demonstrate the mechanical value as compared to the predicate devices, TS Implant System by OSSTEM Implant Co., Ltd. (K121585) according to ASTM F543-17 A3 and each manufacturer drilling sequence. The Results of Pull-out Strength showed that subject devices are substantially equivalent under the worst-case scenario.
MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic IS-III active Short Implants in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices", Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
The results of the above non-clinical tests have met the standards and demonstrated the substantial equivalence with the predicate device.
Conclusion
IS-III active Short Implant 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 Short Implants and their predicates are substantially equivalent.