(343 days)
No
The summary describes a dental implant system made of standard materials and designs, with no mention of AI, ML, or any computational processing capabilities. The testing focuses on material properties, biocompatibility, sterilization, and dimensional compatibility.
Yes
The device is described as "dedicated for two stage surgical procedures and for immediate loading", for use in "mandibles and maxillae, in support of single or multiple-unit restorations". This addresses a medical condition (edentulism) by replacing missing teeth, which is a therapeutic action.
No
The device description and intended use indicate that this device, "I Do," is a dental implant (fixture) designed to replace missing teeth, not to diagnose medical conditions. It supports restorations and is implanted into bone.
No
The device description clearly states that the device consists of "fixtures" which are physical implants made of Ti CP4, designed to be placed in bone. This indicates a hardware component, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the jawbone to support dental restorations. This is a therapeutic and structural function within the human body.
- Device Description: The device is described as a "thread type implant made of Ti CP4" that is "placed in the alveola bone to replace the function of the missing tooth." This is a physical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any testing of samples or diagnostic purposes.
The device described is a dental implant, which is a type of medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The subject implants are compatible with abutments of the IS-III Active System by Neobiotech Co., Ltd., which is FDA-cleared device under the K181138 as below:
| 510(k) number of Compatible Abutments | Compatible model type | Material | Platform Size (mm) | Angulation |
|---|---|---|---|---|
| K181138 | IS Cover Screw | Ti-6Al-4V ELI of ASTM F136 | 3.4/3.55 | 0° |
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 0° | ||
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 0° | ||
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Temporary Abutment | 4.5 | 0° | ||
| IS Abutment Screw | 2.3 | 0° |
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The I Do Fixtures consist of two types of fixtures, Fixture-MT ACTIVE. Both fixtures are a thread type implant made of Ti CP4 according to ASTM F67 which will be placed in the alveola bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixtures' surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
Fixture-S and Fixture MT-Active have same connection but different design.
Fixture S has 2 type of screw bite 0.45mm and 0.35mm in coronal part. Fixture MT-ACTIVE has use only one screw bite of 0.59mm is more tapered.
| Device Component | Diameters (Ø) | Lengths (mm) |
|---|---|---|
| Fixture-S | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 | |
| Fixture-MT ACTIVE | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 |
Tolerance of dimension shall be within ± 1% range. I Do fixtures are provided sterilized.
The subject device is compatible with below abutments:
| K number of Compatible Abutments | Compatible Abutment List | Diameters (Ø) | Lengths (mm) |
|---|---|---|---|
| K181138 | IS Cover Screw | 3.4/3.55 | 5.8/6.8/7.4 |
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 1.0/2.0/3.0/4.0/5.0/6.0/7.0/8.0/9.0 | |
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 4.5/5.5/7.0 | |
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 4.5/5.5/7.0 | |
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 8.0/11.0 | |
| IS Temporary Abutment | 4.5 | 11.5 | |
| IS Abutment Screw | 2.3 | 8.3 |
Materials:
| No. | Part of product | Substances | Standard |
|---|---|---|---|
| 1 | Fixture-S | ||
| 2 | Fixture-MT ACTIVE | TI CP4 | ASTM F67 |
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, in the alveola bone
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.
- 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
- Sterilization Validation Testing according to ISO 11137-1,-2,-3
- Shelf Life Testing according to ASTM F1980
- Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP
- Reverse Engineering Dimensional Analysis between the subject implant and the compatible abutments/ abutment screws
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Testing was conducted for the subject devices, and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K181138.
To demonstrate the compatibility of the proposed dental implant bodies to the identified compatible third-party abutments and abutment screws, the reverse engineering dimensional analysis testing was assessed on the OEM implant bodies, OEM abutments, and OEM abutment screws. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate device.
The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) was provided. To compare surface modification between the subject and predicate devices, surface roughness, chemical analysis for residuals, and SEM imaging were provided and it demonstrated substantial equivalence.
The fatigue testing per ISO 14801 was not conducted as the subject device is not compatible with any angled abutments.
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): 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.
Not Found
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
§ 872.3640 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 shows 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 the FDA logo, which 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.
July 31, 2020
I Do Biotech Co., Ltd % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K192294
Trade/Device Name: I Do Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: July 3, 2020 Received: July 8, 2020
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 (OS) 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.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192294
Device Name I Do
Indications for Use (Describe)
I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The subject implants are compatible with abutments of the IS-III Active System by Neobiotech Co., Ltd., which is FDAcleared device under the K181138 as below:
| 510(k) number
of Compatible
| Abutments | Compatible model type | Material | Platform Size (mm) | Angulation |
|---|---|---|---|---|
| K181138 | IS Cover Screw | Ti-6Al-4V ELI | ||
| of ASTM F136 | 3.4/3.55 | 0° | ||
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 0° | ||
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 0° | ||
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Temporary Abutment | 4.5 | 0° | ||
| IS Abutment Screw | 2.3 | 0° |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
510(k) Summary
Submitter
I Do biotech Co., Ltd. Jae-Hyun Song #C, 135, Seongseodong-ro, Dalsoe-gu Daegu 42721 South Korea Email: idoimplant@naver.com Phone: +82-53-581-2835 Fax: +82-53-584-3835
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: I Do .
- Common Name: Endosseous Dental Implant
- Classification Name: Implant, Dental, Endosseous
- Product Code: DZE
- Panel: Dental
- Regulation Number: 21 CFR 872.3640
- Device Class: Class II
- . Date Prepared: 07/30/2020
Predicate Devices:
K181138, IS-III active System manufactured by Neobiotech Co., Ltd. All fixture models from I Do
Indications for Use:
I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The subject implants are compatible with abutments of the IS-III Active System by Neobiotech Co., Ltd., which is FDA-cleared device under the K181138 as below:
| 510(k) number
of Compatible
| Abutments | Compatible model type | Material | Platform Size (mm) | Angulation |
|---|---|---|---|---|
| K181138 | IS Cover Screw | Ti-6Al-4V ELI | ||
| of ASTM F136 | 3.4/3.55 | 0° | ||
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 0° | ||
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 0° | ||
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| IS Temporary Abutment | 4.5 | 0° | ||
| IS Abutment Screw | 2.3 | 0° |
4
Device Description
The I Do Fixtures consist of two types of fixtures, Fixture-MT ACTIVE. Both fixtures are a thread type implant made of Ti CP4 according to ASTM F67 which will be placed in the alveola bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixtures' surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
Fixture-S and Fixture MT-Active have same connection but different design.
Fixture S has 2 type of screw bite 0.45mm and 0.35mm in coronal part. Fixture MT-ACTIVE has use only one screw bite of 0.59mm is more tapered.
| Device Component | Diameters (Ø) | Lengths (mm) |
|---|---|---|
| Fixture-S | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 | |
| Fixture-MT ACTIVE | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 |
Tolerance of dimension shall be within ± 1% range. I Do fixtures are provided sterilized.
The subject device is compatible with below abutments:
| K number of
Compatible
| Abutments | Compatible Abutment List | Diameters (Ø) | Lengths (mm) |
|---|---|---|---|
| K181138 | IS Cover Screw | 3.4/3.55 | 5.8/6.8/7.4 |
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 1.0/2.0/3.0/4.0/5.0/6.0/7.0/8.0/9.0 | |
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 4.5/5.5/7.0 | |
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 4.5/5.5/7.0 | |
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 8.0/11.0 | |
| IS Temporary Abutment | 4.5 | 11.5 | |
| IS Abutment Screw | 2.3 | 8.3 |
Materials:
| No. | Part of product | Substances | Standard |
|---|---|---|---|
| 1 | Fixture-S | ||
| 2 | Fixture-MT ACTIVE | TI CP4 | ASTM F67 |
5
Summaries of Technological Characteristics:
The subject device is substantially equivalent to the following predicate devices
1) Fixture-S
| Subject Device | Predicate Device | |||
|---|---|---|---|---|
| Company | ||||
| Name | I DO Biotech Co., Ltd. | Neobiotech Co., Ltd. | ||
| Device Name | I DO | IS-III active System | ||
| 510(K) Number | K192294 | K181138 | ||
| Device | ||||
| Classification | Implant, Endosseous Root-Form | Implant, Endosseous Root-Form | ||
| Product Code | DZE | DZE | ||
| Regulation | ||||
| Number | 872.3640 | 872.3640 | ||
| Indications for | ||||
| Use | 510(k) | |||
| number of | ||||
| Compatible | ||||
| Abutments | Compatible model type | Material | IS-III active System is indicated | |
| for use in partially or fully | ||||
| edentulous mandibles and | ||||
| maxillae, in support of single or | ||||
| multiple-unit restorations | ||||
| including; cemented retained, | ||||
| screw retained, or overdenture | ||||
| restorations, and terminal or | ||||
| intermediate Abutment support | ||||
| for fixed bridgework. IS-III | ||||
| active System is dedicated for | ||||
| two stage surgical procedures | ||||
| and for immediate loading when | ||||
| there is good primary stability | ||||
| and an appropriate occlusal load | ||||
| Also, implants with diameters | ||||
| larger than 5mm are indicated | ||||
| for molar regions. | ||||
| K181138 | I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions. | |||
| The subject implants are compatible with abutments of the IS-III Active System by Neobiotech Co., Ltd., which is FDA-cleared device under the K181138 as below: | ||||
| IS Cover Screw | ||||
| IS Healing Abutment | ||||
| IS Solid Abutment | ||||
| IS Cemented Abutment | ||||
| IS Shapable Abutment | ||||
| IS Temporary Abutment | ||||
| IS Abutment Screw | ||||
| Platform Size (mm) | Angulation | |||
| 3.4/3.55 | 0° | |||
| 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 0° | |||
| Ti-6Al-4V | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 0° | ||
| ELI of ASTM | ||||
| F136 | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| F136 | 4.5/5.0/5.5/6.0/6.5 | 0° | ||
| 4.5 | 0° | |||
| 2.3 | 0° |
6
| Material
| Composition | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
|---|---|---|
| Design | Image: dental implant | Image: dental implant |
| Anti-Rotational | ||
| Feature | Internal Hex | Internal Hex |
| Diameters(Ø) | 3.8/4.0/4.5/5.0/5.5/6.0/7.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 |
| Length (mm) | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Surface | ||
| Treatment | SLA | SLA |
| 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. | ||
| Similarities | The I DO Fixture has same device characteristics with the Primary predicate devices, IS-III active System (K181138) such as indications | |
| for use, material, functions, general shape (Design), structure, and applied production method are similar. The surface of the subject | ||
| implant device and predicate device is treated with SLA (Sandblasted with Large-grit and Acid-etching) and it demonstrates the substantial | ||
| equivalence. | ||
| Differences | The differences between subject device and predicate is the diameter of the product and indications for Use. Most diameters are the same, | |
| but there is the diameter difference of Ø3.8 and 3.5. Since the predicate's diameter is smaller than the subject device's, which is that | ||
| predicate is the worse than the subject, this part does not affect implant performance and safety. | ||
| Another difference is Indications for Use statements between two devices. The indications of the subject device include the information of | ||
| the compatible abutments and abutment screws as the subject device system is composed of only dental fixtures. It does not affect | ||
| product's performance and safety. |
7
2) Fixture-MT ACTIVE
| Subject Device | Predicate Device | |||||
|---|---|---|---|---|---|---|
| Company | ||||||
| Name | I DO Biotech Co., Ltd. | Neobiotech Co., Ltd. | ||||
| Device Name | I DO | IS-III active System | ||||
| 510(K) Number | N / A | K181138 | ||||
| Device | ||||||
| Classification | Implant, Endosseous Root-Form | Implant, Endosseous Root-Form | ||||
| Product Code | DZE | DZE | ||||
| Regulation | ||||||
| Number | 872.3640 | 872.3640 | ||||
| I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or | ||||||
| multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and | ||||||
| terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical | ||||||
| procedures and for immediate loading when there is good primary stability and an appropriate occlusal | ||||||
| load. Also, implants with diameters larger than 5mm are indicated for molar regions. | ||||||
| The subject implants are compatible with abutments of the IS-III Active System by Neobiotech Co., Ltd., | ||||||
| which is FDA-cleared device under the K181138 as below: | IS-III active System is | |||||
| indicated for use in partially | ||||||
| or fully edentulous | ||||||
| mandibles and maxillae, in | ||||||
| support of single or multiple-unit restorations including; | ||||||
| cemented retained, screw | ||||||
| retained, or overdenture | ||||||
| restorations, and terminal or | ||||||
| intermediate Abutment | ||||||
| support for fixed | ||||||
| bridgework. IS-III active | ||||||
| System is dedicated for two | ||||||
| stage surgical procedures and | ||||||
| for immediate loading when | ||||||
| there is good primary | ||||||
| stability and an appropriate | ||||||
| occlusal load. Also, implants | ||||||
| with diameters larger than | ||||||
| 5mm are indicated for molar | ||||||
| regions. | ||||||
| Indications for | ||||||
| Use | 510(k) number | |||||
| of Compatible | ||||||
| Abutments | Compatible model type | Material | Platform Size (mm) | Angulation | ||
| K181138 | IS Cover Screw | Ti-6Al-4V ELI | ||||
| of ASTM F136 | 3.4/3.55 | 0° | ||||
| IS Healing Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/7.5/8.0 | 0° | ||||
| IS Solid Abutment | 4.0/4.5/5.0/5.5/6.0/6.5/7.0/8.0 | 0° | ||||
| IS Cemented Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||||
| IS Shapable Abutment | 4.5/5.0/5.5/6.0/6.5 | 0° | ||||
| IS Temporary Abutment | 4.5 | 0° | ||||
| IS Abutment Screw | 2.3 | 0° | ||||
| Material | ||||||
| Composition | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
8
| Page 6 of 7 | |||
|---|---|---|---|
| ------------- | -- | -- | -- |
| Design | Image: Implant | Image: Implant |
|---|---|---|
| Anti-Rotational | ||
| Feature | Internal Hex | Internal Hex |
| Diameters(Ø) | 3.8/4.0/4.5/5.0/5.5/6.0/7.0 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 |
| Length (mm) | 7.3/8.5/10/11.5/13.0/15.0 | 7.3/8.5/10.0/11.5/13.0/15.0 |
| Surface | ||
| Treatment | SLA | SLA |
| 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. | ||
| Similarities | The I DO Fixture has same device characteristics with the Primary predicate devices, IS-III active System (K181138) such as indications | |
| for use, material, functions, general shape (Design), structure, and applied production method are similar. The surface of the subject | ||
| implant device and predicate device is treated with SLA (Sandblasted with Large-grit and Acid-etching) and it demonstrates the | ||
| substantial equivalence. | ||
| Differences | The differences between subject device and predicate is the diameter of the product and Indications for Use. Most diameters are the same, | |
| but there is the diameter difference of Ø3.8 and 3.5. Since the predicate's diameter is smaller than the subject device's, which is that | ||
| predicate is the worse than the subject, this part does not affect implant performance and safety. | ||
| Another difference is Indications for Use statements between two devices. The indications of the subject device include the information of | ||
| the compatible abutments and abutment screws as the subject device system is composed of only dental fixtures. It does not affect | ||
| product's performance and safety. |
9
Non-clinical testing data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- . Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures
- Sterilization Validation Testing according to ISO 11137-1,-2,-3
- Shelf Life Testing according to ASTM F1980 .
- Bacterial Endotoxin Test Report according to ANSI/AAMI ST72:2011, USP , and USP ●
- . Reverse Engineering Dimensional Analysis between the subject implant and the compatible abutments/ abutment screws
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Testing was conducted for the subject devices, and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K181138.
To demonstrate the compatibility of the proposed dental implant bodies to the identified compatible third-party abutments and abutment screws, the reverse engineering dimensional analysis testing was assessed on the OEM implant bodies, OEM abutments, and OEM abutment screws. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate device.
The surface modification information with SLA (Sandblasted with Large-grit and Acid-etching) was provided. To compare surface modification between the subject and predicate devices, surface roughness, chemical analysis for residuals, and SEM imaging were provided and it demonstrated substantial equivalence.
The fatigue testing per ISO 14801 was not conducted as the subject device is not compatible with any angled abutments.
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
I Do Fixtures 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, I Do Fixtures and its predicates are substantially equivalent.