(343 days)
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 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 provided FDA 510(k) summary (K192294) describes the "I Do" dental implant system. This document is a premarket notification for a new device claiming substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria for performance through clinical trials or extensive standalone algorithm testing.
The document focuses on demonstrating that the "I Do" dental implant system is substantially equivalent to a previously cleared predicate device (IS-III active System, K181138) based on material, design, manufacturing, and non-clinical testing. It does not present a study with performance metrics in the typical sense of accuracy, sensitivity, or specificity for an AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable as this is not a performance study of an AI/ML diagnostic or therapeutic device.
Here's an interpretation based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device through non-clinical testing and comparison of technical characteristics. The "reported device performance" refers to the outcomes of these non-clinical tests meeting the relevant standards.
| Acceptance Criteria (from applied standards, implicitly) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Biocompatibility (ISO 10993 standards) | "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." |
| Sterilization Validation (ISO 11137 standards) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Shelf Life (ASTM F1980) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Bacterial Endotoxin (ANSI/AAMI ST72, USP <161>, <85>) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Implant-to-Abutment Compatibility (Dimensional Analysis) | "The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate device." |
| Surface Modification (Roughness, Chemical Analysis, SEM) | "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." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This is a technical equivalence review based on non-clinical testing (biocompatibility, sterilization, dimensional analysis, material characterization), not a clinical performance study with a "test set" of patient data in the context of an AI/ML algorithm.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing performed on the device components and comparisons to the predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in a clinical context for this type of submission. The evaluation relies on standardized laboratory testing protocols and engineering comparisons.
4. Adjudication method for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- Not applicable for a clinical ground truth. The "ground truth" or reference standards are defined by the accepted international and national standards for materials, biocompatibility, sterilization, and mechanical compatibility of dental implants (e.g., ISO 10993, ISO 11137, ASTM F1980, ANSI/AAMI ST72, ASTM F67, ISO 14801 implicitly for angled abutments but noted as not needed for this device).
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
{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) numberof CompatibleAbutments | Compatible model type | Material | Platform Size (mm) | Angulation |
|---|---|---|---|---|
| K181138 | IS Cover Screw | Ti-6Al-4V ELIof 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) numberof CompatibleAbutments | Compatible model type | Material | Platform Size (mm) | Angulation |
|---|---|---|---|---|
| K181138 | IS Cover Screw | Ti-6Al-4V ELIof 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 ofCompatibleAbutments | 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 | |||
|---|---|---|---|---|
| CompanyName | I DO Biotech Co., Ltd. | Neobiotech Co., Ltd. | ||
| Device Name | I DO | IS-III active System | ||
| 510(K) Number | K192294 | K181138 | ||
| DeviceClassification | Implant, Endosseous Root-Form | Implant, Endosseous Root-Form | ||
| Product Code | DZE | DZE | ||
| RegulationNumber | 872.3640 | 872.3640 | ||
| Indications forUse | 510(k)number ofCompatibleAbutments | Compatible model type | Material | IS-III active System is indicatedfor use in partially or fullyedentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. IS-IIIactive System is dedicated fortwo stage surgical proceduresand for immediate loading whenthere is good primary stabilityand an appropriate occlusal loadAlso, implants with diameterslarger than 5mm are indicatedfor 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 ASTMF136 | 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}------------------------------------------------
| MaterialComposition | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
|---|---|---|
| Design | Image: dental implant | Image: dental implant |
| Anti-RotationalFeature | 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 |
| SurfaceTreatment | SLA | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle ofOperation | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of themissing teeth as a dental implant fixture. | This product is a root-typefixture which is inserted in thealveolar bone. It replaces thefunctions of the missing teeth asa dental implant fixture. |
| Similarities | The I DO Fixture has same device characteristics with the Primary predicate devices, IS-III active System (K181138) such as indicationsfor use, material, functions, general shape (Design), structure, and applied production method are similar. The surface of the subjectimplant device and predicate device is treated with SLA (Sandblasted with Large-grit and Acid-etching) and it demonstrates the substantialequivalence. | |
| 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 thatpredicate 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 ofthe compatible abutments and abutment screws as the subject device system is composed of only dental fixtures. It does not affectproduct's performance and safety. |
{7}------------------------------------------------
2) Fixture-MT ACTIVE
| Subject Device | Predicate Device | |||||
|---|---|---|---|---|---|---|
| CompanyName | I DO Biotech Co., Ltd. | Neobiotech Co., Ltd. | ||||
| Device Name | I DO | IS-III active System | ||||
| 510(K) Number | N / A | K181138 | ||||
| DeviceClassification | Implant, Endosseous Root-Form | Implant, Endosseous Root-Form | ||||
| Product Code | DZE | DZE | ||||
| RegulationNumber | 872.3640 | 872.3640 | ||||
| I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single ormultiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, andterminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgicalprocedures and for immediate loading when there is good primary stability and an appropriate occlusalload. 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 isindicated for use in partiallyor fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate Abutmentsupport for fixedbridgework. IS-III activeSystem is dedicated for twostage surgical procedures andfor immediate loading whenthere is good primarystability and an appropriateocclusal load. Also, implantswith diameters larger than5mm are indicated for molarregions. | |||||
| Indications forUse | 510(k) numberof CompatibleAbutments | Compatible model type | Material | Platform Size (mm) | Angulation | |
| K181138 | IS Cover Screw | Ti-6Al-4V ELIof 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° | ||||
| MaterialComposition | TI CP4 of ASTM F67 | TI CP4 of ASTM F67 |
{8}------------------------------------------------
| Page 6 of 7 | |||
|---|---|---|---|
| ------------- | -- | -- | -- |
| Design | Image: Implant | Image: Implant |
|---|---|---|
| Anti-RotationalFeature | 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 |
| SurfaceTreatment | SLA | SLA |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Principle ofOperation | This product is a root-type fixture which is inserted in the alveolar bone. It replaces the functions of themissing teeth as a dental implant fixture. | This product is a root-typefixture which is inserted inthe alveolar bone. It replacesthe functions of the missingteeth as a dental implantfixture. |
| Similarities | The I DO Fixture has same device characteristics with the Primary predicate devices, IS-III active System (K181138) such as indicationsfor use, material, functions, general shape (Design), structure, and applied production method are similar. The surface of the subjectimplant device and predicate device is treated with SLA (Sandblasted with Large-grit and Acid-etching) and it demonstrates thesubstantial 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 thatpredicate 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 ofthe compatible abutments and abutment screws as the subject device system is composed of only dental fixtures. It does not affectproduct'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 <161>, and USP ● <85>
- . 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.
§ 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.