(255 days)
No
The document describes dental abutments and their manufacturing process using CAD/CAM technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an aid in prosthetic rehabilitation on dental implants, suggesting it is a component of a dental prosthesis rather than a direct therapeutic agent.
No
The devices described (abutments and healing abutments) are intended for prosthetic rehabilitation on dental implants, not for diagnosing medical conditions.
No
The device description clearly details physical components (abutments made of Ti-6Al-4V ELI alloy and zirconia, abutment screws) and manufacturing processes (machining, cementing). It also mentions sterilization and biocompatibility testing, which are relevant to physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for use on dental implants as an aid in prosthetic rehabilitation. This is a direct medical intervention involving the placement of a physical device within the body.
- Device Description: The description details the materials and manufacturing of dental abutments, which are components used to connect a dental prosthesis to a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. These devices are used in vivo (within the body) as part of a surgical and prosthetic procedure.
N/A
Intended Use / Indications for Use
The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.
Product codes
NHA
Device Description
The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.
The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. This abutment is to be used only with implants placed straight. It is made of Ti-6Al-4V ELI alloy. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use after the cementation of the Zirconia top-half.
The Scan Healing Abutment designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.
A groove is added to the top part to check the diameter, and to the connection part to check the correct connection with the fixture. And notches are added to check height (area excluding the length of the connection area from the total length).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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:
- Sterilization validation:
- TiGEN Abutment and ZrGEN Abutment: supplied non-sterile. TiGEN Abutment sterilization validated by steam sterilization according to ISO 17665-1 and ISO 17665-2, leveraged from K182448. ZrGEN Abutment cemented Zirconia top-half steam sterilization according to ISO 17665-1 and ISO 17665-2.
- Scan Healing Abutment: supplied sterile. Sterilization validation by gamma irradiation according to ISO 1137 for sterility assurance level (10^-6), leveraged from K110955.
- Pyrogen and Endotoxin Test: Scan Healing Abutment: endotoxin testing on every batch with limit below 0.5 EU/mL (USP 39), not labeled "non-pyrogenic".
- Biocompatibility:
- TiGEN Abutment: evaluated according to ISO 10993-1, leveraged from K182448 (same material and surface treatment).
- ZrGEN Abutment: evaluated according to ISO 10993-1, cytotoxicity (ISO 10993-5) confirmed non-cytotoxic.
- Scan Healing Abutment: evaluated according to ISO 10993-1, leveraged from K182448 (same material and surface treatment).
- Performance Test: Fatigue testing performed on worst-case TiGEN Abutment and compatible implant fixture constructs according to ISO 14801:2016.
- Accelerated shelf life Test: Performed according to ASTM F1980, leveraged from K110955, validated 5 years shelf life.
- MR Compatibility: Non-clinical worst-case MRI review performed based on scientific rationale and published literature (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). Rationale addressed parameters for magnetically induced displacement force and torque per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".
Clinical Testing: No clinical studies are submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K122231, K123988, K150537, K171622, K110955, K173374, K182448
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
MegaGen Implant Co., Ltd. % Hyo-Eun Lee Assistant Research Engineer DaeGyeong Regulatory Affairs Institute 32, Innovalley-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA
Re: K220562
Trade/Device Name: TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 7, 2022 Received: October 11, 2022
Dear Hyo-Eun Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment
Indications for Use (Describe)
The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary for K220562
Date: Nov 09, 2022
1. Applicant / Submitter
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
Hyo-Eun Lee MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3860 Fax: Fax: +82-53-289-3420 Email: ra7@imegagen.com
3. Device
| • Trade Name | TiGEN Abutment,
ZrGEN Abutment and
Scan Healing Abutment |
|-------------------------------|----------------------------------------------------------------|
| • Common Name | Endosseous dental implant abutment |
| • Classification Name | Endosseous dental implant abutment |
| • Classification Product Code | NHA |
| • Classification regulation | Class II, 21 CFR 872.3630 |
4. Predicate Device
• Primary Predicate Device:
K150203 Medentika CAD/CAM Abutments
• Reference Device:
K122231 XPEED AnyRidge Internal Implant System K123988 AnyOne Internal Implant System K150537 MiNi Internal Implant System K171622 Dentium Ti-Base K110955 AnyRidge Internal Implant System K173374 TSV™ BellaTek® Encode® Healing Abutments K182448 AnyRidge Octa 1 Implant System
4
5. Description
The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.
The dimensions of TiGEN Abutment are follows:
| Standard Type | Total length (mm) | 28.00, 28.40, 28.60, 28.70, 28.90, 29.05, 30.55 |
|---|---|---|
| Diameter (mm) | 10.00, 12.00 | |
| Octa level Type | Total length (mm) | 26.00 |
| Diameter (mm) | 10.00, 12.00 |
The allowable ranges of design parameters after CAD/CAM patient-matching are follows:
| Standard Type | Minimum wall thickness (mm) | 0.47 |
|---|---|---|
| Maximum angulation (°) | 30 | |
| Minimum gingival collar height (mm) | 2.00 | |
| Maximum gingival collar height (mm) | 5.00 | |
| Minimum gingival collar (ø) | 3.50, 4.00, 4.50 | |
| Maximum gingival collar (ø) | 9.50, 11.50 | |
| Minimum post height (mm) | 4.00 | |
| Maximum post height (mm) | 6.00, 6.50 | |
| Octa level Type | Minimum wall thickness (mm) | 0.47 |
| Maximum angulation (°) | 30 | |
| Minimum gingival collar (ø) | 4.00 | |
| Maximum gingival collar (ø) | 9.50, 11.50 | |
| Minimum post height (mm) | 4.00 | |
| Maximum post height (mm) | 6.00 |
The TiGEN Abutment is compatible with following MEGAGEN Implants and Screw cleared under:
| Type | Name | Dental Implant | Octa Abutment | Screw | ||||
|---|---|---|---|---|---|---|---|---|
| The widest | ||||||||
| diameter (mm) | Platform | |||||||
| Diameter | ||||||||
| (mm) | 510(k) | |||||||
| Number | Connection | |||||||
| Diameter | ||||||||
| (mm) | 510(k) | |||||||
| Number | 510(k) | |||||||
| Number | Model | |||||||
| Name | ||||||||
| Standard | ||||||||
| Type | XPEED | |||||||
| AnyRidge | ||||||||
| Internal Fixture | 4.0, 4.4, 4.9, 5.4, | |||||||
| 5.9, 6.4, 6.9, 7.4, | ||||||||
| 7.9, 8.4 | 2.31, 2.8, | |||||||
| 3.1, 3.3 | K122231, | |||||||
| K123870, | ||||||||
| K140091 | - | - | K110955 | AANMSF | ||||
| AnyOne | ||||||||
| Internal Fixture | 3.9, 4.3, 4.8, 5.3, | |||||||
| 5.8, 6.3, 6.8, 7.3, | ||||||||
| 7.8, 8.3 | K123988 | - | - | K123988 | AS20 | |||
| MINi Internal | ||||||||
| Fixture | 3.0, 3.4 | K150537 | - | - | K150537 | MIAS14 | ||
| AnyRidge Octa | ||||||||
| 1 Fixture | 3.6, 4.0, 4.4, 4.7, | |||||||
| 4.8, 5.0, 5.5 | K182448 | - | - | K182448 | AROAS16B, | |||
| AROAS16 | ||||||||
| Octa Level | ||||||||
| Type | XPEED | |||||||
| AnyRidge | ||||||||
| Internal Fixture | 4.0, 4.4, 4.9, 5.4, | |||||||
| 5.9, 6.4, 6.9, 7.4, | ||||||||
| 7.9, 8.4 | 3.8, 4.0, | |||||||
| 4.8, 5.0, | ||||||||
| 5.8, 6.0 | K122231, | |||||||
| K123870, | ||||||||
| K140091 | 4.0, 5.0, 6.0 | K110955 | K123988 | |||||
| AnyOne | ||||||||
| Internal Fixture | 3.9, 4.3, 4.8, 5.3, | |||||||
| 5.8, 6.3, 6.8, 7.3, | ||||||||
| 7.8, 8.3 | K123988 | 3.8, 4.8, 5.8 | K123988 | IRCS200 | ||||
| AnyRidge Octa | ||||||||
| 1 Fixture | 3.6, 4.0, 4.4, 4.7, | |||||||
| 4.8, 5.0, 5.5 | K182448 | 4.0, 5.0, 6.0 | K182448 |
5
The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. This abutment is to be used only with implants placed straight. It is made of Ti-6Al-4V ELI alloy. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use after the cementation of the Zirconia top-half.
| Standard Type | Total length (mm) | 5.10, 5.50, 7.50, 7.70, 8.00, 8.15, 8.40, 8.60, 8.90, 9.00, 9.05, 9.20, 9.50, 9.65, 9.90, 10.10, 10.40, 10.55, 11.15, 11.55, 11.65, 12.05, 12.55, 13.05, 13.15, 13.55, 14.05, 14.55, 15.05, 15.55, 16.55 |
|---|---|---|
| Diameter (mm) | 3.1, 4.0, 4.4, 4.5, 5.0, 5.5, 6.0 | |
| C- Type | Total length (mm) | 7.9, 8.2, 8.35, 8.4, 8.7, 8.85, 9.4, 9.7, 9.85, 10.35, 11.35 |
| Diameter (mm) | 3.9, 4.3, 5.5 | |
| Octa level Type | Total length (mm) | 5.80 |
| Diameter (mm) | 5.0, 5.5, 6.5 |
The dimensions of ZrGEN Abutment are follows:
| The allowable ranges of design parameters after CAD/CAM patient-matching are follows: | ||||
|---|---|---|---|---|
| | | ZrGEN Abutment
(Standard Type) | Minimum wall thickness (mm) | 0.4, 0.41, 0.43, 0.5, 0.55, 0.8, 1.05, 1.18 |
|----------|---------------|-------------------------------------|-------------------------------------|---------------------------------------------|
| | | | Maximum angulation (°) | 0 |
| | | | Minimum gingival collar (Ø) | 2.2, 3.15, 3.25, 3.75, 4.25, 4.5 |
| | | | Maximum gingival collar (Ø) | 3.1, 4.0, 4.4, 4.5, 5.0, 5.5, 6.0 |
| | | | Minimum post height (mm) | 1.2, 3.2, 4.7, 6.7 |
| | | | Maximum post height (mm) | 2.5, 4.5, 6.0, 8.0 |
| | | ZrGEN Abutment
(C-Type) | Minimum wall thickness (mm) | 0.12, 0.15,0.22, 0.32, 0.35, 0.42 |
| | | | Maximum angulation (°) | 0 |
| | titanium base | | Minimum gingival collar (Ø) | 3, 3.4 |
| | | | | Maximum gingival collar (Ø) |
| | | | | Minimum post height (mm) |
| | | | | Maximum post height (mm) |
| Zirconia | | ZrGEN Abutment
(Octa level type) | Minimum wall thickness (mm) | 0.75, 0.85, 1.35 |
| Abutment | | | | Maximum angulation (°) |
| | | | | Minimum gingival collar (Ø) |
| | | | | Maximum gingival collar (Ø) |
| | | | | Minimum post height (mm) |
| | | | | Maximum post height (mm) |
| | | | Minimum wall thickness (mm) | 0.5 |
| | | | Maximum angulation (°) | 0 |
| | | | Minimum gingival collar (Ø) | 8 |
| | | zirconia top-half | Maximum gingival collar (Ø) | 10 |
| | | | Minimum Gingival collar height (mm) | 2 |
| | | | Maximum Gingival collar height (mm) | 5 |
| | | | Minimum post height (mm) | 7 |
| | | | Maximum post height (mm) | 15 |
| | | | | |
The ZrGEN Abutment is compatible with following MEGAGEN Implants and Screw cleared under:
| Type | Name | Dental Implant | Octa Abutment | Screw | |||
|---|---|---|---|---|---|---|---|
| The widest diameter | |||||||
| (mm) | Platform | ||||||
| Diameter | |||||||
| (mm) | 510(k) | ||||||
| Number | Connection | ||||||
| Diameter | |||||||
| (mm) | 510(k) | ||||||
| Number | Model | ||||||
| Name | |||||||
| Standard | |||||||
| Type | XPEED AnyRidge | ||||||
| Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, | ||||||
| 6.9, 7.4, 7.9, 8.4 | - | K122231, | |||||
| K123870, | |||||||
| K140091 | - | K110955 | AANMSF | ||||
| AnyOne Internal | |||||||
| Fixture | 3.9, 4.3, 4.8, 5.3, 5.8, | ||||||
| 6.3, ,6.8, 7.3, 7.8, 8.3 | - | K123988 | - | K123988 | AS20 | ||
| MINi Internal | |||||||
| Fixture | 3.0, 3.4 | 2.31, 2.8, | |||||
| 3.1, 3.3 | K150537 | - | K150537 | MIAS14 | |||
| AnyRidge Octa 1 | |||||||
| Fixture | 3.6, 4.0, 4.4, 4.7, 4.8, | ||||||
| 5.0,5.5 | - | K182448 | - | K182448 | AROAS16B, | ||
| AROAS16 | |||||||
| C-Type | XPEED AnyRidge | ||||||
| Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, | ||||||
| 6.9, 7.4, 7.9, 8.4 | - | K122231, | |||||
| K123870, | |||||||
| K140091 | - | K110955 | AANMSF | ||||
| AnyOne Internal | |||||||
| Fixture | 3.9, 4.3, 4.8, 5.3, 5.8, | ||||||
| 6.3, ,6.8, 7.3, 7.8, 8.3 | - | K123988 | - | K123988 | AS20 | ||
| AnyRidge Octa 1 | |||||||
| Fixture | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0, | ||||||
| 5.5 | - | K182448 | - | K182448 | AROAS16B, | ||
| AROAS16 | |||||||
| Octa | |||||||
| Level | |||||||
| Type | XPEED AnyRidge | ||||||
| Internal Fixture | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, | ||||||
| 6.9, 7.4, 7.9, 8.4 | 3.8, 4.0, | K122231, | |||||
| K123870, | |||||||
| K140091 | 4.0, 5.0, | ||||||
| 6.0 | K110955 | - | |||||
| AnyOne Internal | |||||||
| Fixture | 3.9, 4.3, 4.8, 5.3, 5.8, | ||||||
| 6.3, ,6.8, 7.3, 7.8, 8.3 | 4.8, 5.0, | ||||||
| 5.8, 6.0 | K123988 | 3.8, 4.8, | |||||
| 5.8 | K123988 | IRCS200 | |||||
| AnyRidge Octa 1 | |||||||
| Fixture | 3.6, 4.0, 4.4, 4.7, 4.8, 5.0, | ||||||
| 5.5 | - | K182448 | 4.0, 5.0, | ||||
| 6.0 | K182448 | - |
6
The Scan Healing Abutment designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.
A groove is added to the top part to check the diameter, and to the connection part to check the correct connection with the fixture. And notches are added to check height (area excluding the length of the connection area from the total length). The detail information of groove and notch is below.
| Diameter (Ø, mm) | 4.2 | 4.7 | 5.7 | |
|---|---|---|---|---|
| Groove | 0 | 1 | 2 | |
| Height | ||||
| (mm) | AnyRidge | 6.9 | 7.9 | 9.9 |
| AnyOne | 6.7 | 7.7 | 9.7 | |
| AnyRidge Octa 1 | 7.35, 8.85 | 8.35, 9.85 | 10.35, 11.85 | |
| Notch | 0 | 1 | 2 | |
| Anodizing | Gold | NA | Green |
The dimensions of scan Healing Abutment are follows:
| Total length (mm) | 6.9, 6.7, 7.35, 7.7, 7.9, 8.35, 8.85, 9.79, 9.9, 10.35, 11.85 |
|---|---|
| Diameter (mm) | 4.2, 4.7, 5.7, 6.7 |
The Scan Healing Abutment is compatible with following MEGAGEN Implants and Screw cleared under:
| Compatible Implant
System | Device Name | 510(k)
Number | The widest Diameter
(mm) | Model Name |
|-------------------------------------------|------------------------------------|-------------------------------|-----------------------------------------------------|------------------------------------|
| Xpeed AnyRidge
Internal Implant System | Xpeed AnyRidge
Internal Fixture | K122231
K123870
K140091 | 4.0, 4.4, 4.9, 5.4, 5.9,
6.4, 6.9, 7.4, 7.9, 8.4 | ARIHS1804, ARIHS1805,
ARIHS1807 |
| AnyOne
Internal Implant System | AnyOne
Internal Fixture | K123988 | 3.9, 4.3, 4.8, 5.3, 5.8,
6.3, 6.8, 7.3, 7.8, 8.3 | AOIHS2004, AOIHS2005,
AOIHS2007 |
| AnyRidge Octa 1 Implant
System | AnyRide Octa 1
Fixture | K182448 | 3.6, 3.7, 4.0, 4.1, 4.4,
4.8, 5.0, 5.5 | AROHS1604, AROHS1605,
AROHS1607 |
6. Indication for use
The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.
For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.
7
7. Basis for Substantial Equivalence
| 7.1. Comparison of the Indications for Use | ||||
|---|---|---|---|---|
| Subject Device | Table of Substantial Equivalence - Indications for Use | |||
| Indications for Use | ||||
| MegaGen Co., Ltd. | The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental | |||
| implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. | ||||
| For TIGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and | ||||
| ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture. | ||||
| Predicate Device | Indications for Use | |||
| Medentika GmbH | Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or | |||
| multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. | ||||
| Medentika | ||||
| CAD/CAM | ||||
| Abutments | ||||
| K150203 | Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
| Nobel Biocare Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 | |
| Nobel Biocare NobelActive™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) | |
| Biomet 3i Osseotite® Certain® | H | 3.24, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | |
| Nobel Biocare Brånemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 | |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 | |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5(NNC), 4.8, 6.5 | |
| Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 | |
| Astra Tech OsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 | |
| Dentsply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 | |
| Medentika PreFace is intended for use with the Straumann® CARES® System. All digitally designed abutments for | ||||
| use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated | ||||
| milling center. | ||||
| Reference Device | ||||
| MegaGen Co., Ltd | Indications for Use | |||
| XPEED AnyRidge | ||||
| Internal Implant | ||||
| System | ||||
| K122231 | The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular | |||
| molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) | ||||
| in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less | ||||
| than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate | ||||
| occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | ||||
| MegaGen Co., Ltd | ||||
| AnyOne Internal | ||||
| Implant System | ||||
| K123988 | The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar | |||
| areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in | ||||
| partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less | ||||
| than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate | ||||
| occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. | ||||
| MegaGen Co., Ltd | ||||
| MiNi Internal | ||||
| Implant System | ||||
| K150537 | The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with | |||
| the following clinical protocols: |
- The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors
and mandibular incisors. - Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
- It is intended for delayed loading. | | | |
| MegaGen Co., Ltd
AnyRidge
Internal System
K110955 | The AnyRidge Internal Implant System is intended to be surgically in the maxillary or mandibular molar areas for the
purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully
edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.00mm) are
dedicated for immediate when good primary stability is achieved and with appropriate occlusal loading. Larger implants
are dedicated for the molar region and are indicated for delayed loading. | | | |
| Dentium Co., Ltd.
Dentium
Ti-Base | Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially
edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. All digitally designed abutments for use with
Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture. | | | |
7.1. Comparison of the Indications for Use
8
| Biomet 3i
BellaTek Encode
Healing Abutments
| K173374 | The TSV BellaTek Encode Healing Abutments are intended for use as an accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tissue for acceptance of a final abutment and restoration. |
|---|---|
| Substantial Equivalence Discussion |
1. Similarities
The indications for use statement of the subject device has the primary predicate device, K150203, to support prosthetic rehabilitation when used with dental implants in the maxilla or fully edentulous patients. Both the subject device and predicate device are intended for the digitally designed abutments to be manufactured at valiling centers owned by each applicant.
2. Differences
The indications for use statement of the subject device is nearly identical to the primary predicate, except for minor changes in wording that do not affect the intended use. Different validated milling centers owned by each applicant are also referenced.
3. Discussion
The differences in the indications for use statement between the subject device and primary predicate device, K150203, are only minor changes in wording and do not affect the intended use for demonstrating substantial equivalence.
Based on the information in the submission, it is concluded that the substantially equivalent to the predicate device.
9
7.2 Comparison for each component
| 7.2.1
| TiGEN Abutment | ||||||
|---|---|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Devices | ||||
| 510(k) Number | K220562 | K150203 | K122231 | K123988 | K150537 | K182448 |
| Device Name | TIGEN Abutment | Medentika | ||||
| CAD/CAM | ||||||
| Abutments | XPEED AnyRidge | |||||
| Internal Implant | ||||||
| System | AnyOne Internal | |||||
| Implant System | MiNi Internal Implant | |||||
| System | Ota Abutment For | |||||
| AnyRidge Octa 1 | ||||||
| Implant System | ||||||
| Manufacturer | MegaGen Co., Ltd. | Medentika GmbH | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. |
| Abutment Design | CAD/CAM Blank | CAD/CAM Blank | Multiple Designs | Multiple Designs | Multiple Designs | Multiple Designs |
| Restoration | Single-unit, | |||||
| Multi-unit | Single-unit, | |||||
| Multi-unit | Single-unit, | |||||
| Multi-unit | Single-unit, | |||||
| Multi-unit | Single-unit, | |||||
| Multi-unit | Single-unit, | |||||
| Multi-unit | ||||||
| Abutment Angle | Up to 30° | Up to 30° | 15°, 25° | 15°, 25° | 15° | 0° |
| Abutment/ | ||||||
| Implant | ||||||
| Interface | Internal, External | Internal, External | Internal | Internal | Internal | Internal |
| Abutment | ||||||
| Material | Ti-6Al-4V ELI | Titanium Alloy | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Sterilization | Non-sterile; intended | |||||
| for terminal | ||||||
| sterilization via | ||||||
| autoclave | Non-sterile | Non-sterile; intended | ||||
| for terminal | ||||||
| sterilization via | ||||||
| autoclave | Non-sterile; intended | |||||
| for terminal | ||||||
| sterilization via | ||||||
| autoclave | Non-sterile; intended | |||||
| for terminal | ||||||
| sterilization via | ||||||
| autoclave | Non-sterile; intended | |||||
| for terminal | ||||||
| sterilization via | ||||||
| autoclave | ||||||
| Abutment | ||||||
| Diameter (mm) | 10, 12 | 3.0~7.0 | 4.0~10.0 | 3.8~10.0 | 3.0~3.5 | 3.8 |
| Octa abutment | ||||||
| Interface | ||||||
| Abutment | TIGEN Abutment | |||||
| (Octa level), is used | ||||||
| with Octa Abutment. | ||||||
| Image: TIGEN Abutment | Unknown | Gold Cylinder | ||||
| Plastic Cylinder and | ||||||
| CCM Cylinder, EZ Post | ||||||
| Cylinder are used with | ||||||
| Octa Abutment. | ||||||
| Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | Gold Cylinder | |||||
| Plastic Cylinder and | ||||||
| CCM Cylinder, EZ Post | ||||||
| Cylinder are used with | ||||||
| Octa Abutment. | ||||||
| Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | NA | Gold Cylinder | ||||
| Plastic Cylinder and | ||||||
| CCM Cylinder, EZ Post | ||||||
| Cylinder are used with | ||||||
| Octa Abutment. | ||||||
| Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | ||||||
| Platform | ||||||
| Diameter (mm) | -Standard Type | |||||
| : 2.31, 2.8, 3.1, 3.3 | ||||||
| -Octa Level Type | ||||||
| : 3.8, 4.0, 4.8, 5.0, | ||||||
| 5.8, 6.0 | Unknown | 3.1 | 3.1, 3.3 | 2.31 | 2.8, 3.3 |
10
| Fixture Diameter
| (mm) | Standard Type | ||||||
|---|---|---|---|---|---|---|---|
| XPEED | |||||||
| AnyRidg e | |||||||
| Internal Implant System | |||||||
| AnyOne Internal Implant System | |||||||
| MiNi Internal Implant System | |||||||
| AnyRidg e Octa 1 Implant System | 3.5, 4.0, | ||||||
| 4.5, 5.0, | |||||||
| 5.5, 6.0, | |||||||
| 6.5, 7.0, | |||||||
| 7.5, 8.0 | |||||||
| 3.5, 4.0, | |||||||
| 4.5, 5.0, | |||||||
| 6.0, 7.0, | |||||||
| 7.5, 8.0 | |||||||
| 3.0, | |||||||
| 3.25 | |||||||
| 3.6, 3.7, | |||||||
| 4.0, 4.1, | |||||||
| 4.4, 4.8, | |||||||
| 5.0, 5.5 | 3.3~7.0 | Internal type: | |||||
| 4.0, 4.4, 4.9, 5.4, 5.9 | |||||||
| (For normal ridge) | |||||||
| 6.4, 6.9, 7.4, 7.9, 8.4 | |||||||
| (For low ridge) | Internal type: | ||||||
| 3.9, 4.3, 4.8, 5.3, 6.3, | |||||||
| 7.3 | |||||||
| (For normal ridge) | |||||||
| 4.8, 5.8, 6.8, 7.8, 8.3 | |||||||
| (For deep Thread) | |||||||
| 4.8, 5.3, 6.3, 7.3 | |||||||
| (For special length) | Internal Type; | ||||||
| 3.0, 3.4 | 3.6, 4.0, 4.4, 4.7, 4.8, | ||||||
| 5.0, 5.5 | |||||||
| Octa Level Type | |||||||
| XPEED | |||||||
| AnyRidg e | |||||||
| Internal Implant System | |||||||
| AnyOne Internal Implant System | |||||||
| AnyRidg e Octa 1 Implant System | 3.5, 4.0, | ||||||
| 4.5, 5.0, | |||||||
| 5.5, 6.0, | |||||||
| 6.5, 7.0, | |||||||
| 7.5, 8.0 | |||||||
| 3.5, 4.0, | |||||||
| 4.5, 5.0, | |||||||
| 6.0, 7.0, | |||||||
| 7.5, 8.0 | |||||||
| 3.6, 3.7, | |||||||
| 4.0, 4.1, | |||||||
| 4.4, 4.8, | |||||||
| 5.0, 5.5 | |||||||
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device, K150203.
- Indications for use, Abutment Design, Restoration, Abutment/Implant Interface and Abutment Material.
The sterilization method is the same as the reference device, K182448.
2. Difference
The subject device has the different characteristic for the Octa Abutment Interface.
- It is unknown if K150203 has not Octa Level Abutment is identical with K122231 and K123988 that they are fastened on Octa Abutment.
3. Discussion
The subject device and primary predicate device are cylindrich with precision implant / abutment interface for use in fabricating a patientspecific abutment at a manufacturer-validated milling center.
The subject device and predicate device have common as following the storation, Abutment Angle, Abutment/Implant Interface. Abutment Material and Abutment angle.
For the Abutnent angle of subject devices, the worst assems of yoe and Octa Level Type and faligue tests were performed to confirm the substantial equivalence in accordance with 'SO 14801 ' and 'Cass II Special Controls Guidance Document: Root form Endosseous Dental Implants and Endosseous Dental Implant Abutnent'. The test result subject device is substantially equivalent to the predicate device and the difference is not affecting the substantial equivalence.
The subject device and reference device, K122231 and K123988, have common as following: Octa Abutment Interface.
The subject device is supplied in nor-sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 1765-1, 2 to verify the sterility assurance lization validation of non-sterile subject device can be leverged with reference device which was evaluated under the previous 510(k) submission. K182448.
Based on the information based in submission, it is concluded that the substantially equivalent to the predicate device.
11
ZrGEN Abutment 7.2.2
| 7.2.2 ZrGEN Abutment | ||||||||
|---|---|---|---|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Devices | ||||||
| 510(k) Number | K220562 | K150203 | K171622 | K122231 | K123988 | K150537 | ||
| Device Name | ZrGEN Abutment | Medentika | ||||||
| CAD/CAM | ||||||||
| Abutments | Dentium Ti-Base | XPEED AnyRidge | ||||||
| Internal Implant | ||||||||
| System | AnyOne Internal | |||||||
| Implant System | MiNi Internal | |||||||
| Implant | ||||||||
| System | ||||||||
| Manufacturer | MegaGen Co., Ltd. | Medentika GmbH | Dentium Co., | |||||
| Ltd. | MegaGen Co., Ltd. | MegaGen Co., Ltd. | MegaGen Co., | |||||
| Ltd. | ||||||||
| Abutment | ||||||||
| Design | TiBase | TiBase | TiBase | Multiple Designs | Multiple Designs | Multiple | ||
| Designs | ||||||||
| Restoration | Single-unit, | |||||||
| Multi-unit | Single-unit, | |||||||
| Multi-unit | Single-unit, | |||||||
| Multi-unit | Single-unit, | |||||||
| Multi-unit | Single-unit, | |||||||
| Multi-unit | Single-unit, | |||||||
| Multi-unit | ||||||||
| Abutment | ||||||||
| Angle | 0° | Up to 30° | Up to 30° | 15°, 25° | 15°, 25° | 15° | ||
| Prosthesis | ||||||||
| Attachment | Cement-retained | |||||||
| Screw-retationed | Cement-retained | Cement- | ||||||
| retained | ||||||||
| Screw- | ||||||||
| retationed | Cement-retained | |||||||
| Screw-retationed | Cement-retained | |||||||
| Screw-retationed | Cement- | |||||||
| retained | ||||||||
| Screw- | ||||||||
| retationed | ||||||||
| Abutment/ | ||||||||
| Implant | ||||||||
| Interface | Internal, External | Internal, External | Internal | Internal | Internal | Internal | ||
| Top-half | ||||||||
| Material | Zirconia | |||||||
| ISO 13356 | unknown | Zirconia | ||||||
| ISO 13356 | Zirconia | |||||||
| ISO 13356 | Zirconia | |||||||
| ISO 13356 | Zirconia | |||||||
| ISO 13356 | ||||||||
| Range of | ||||||||
| Top-half | ||||||||
| Design | ||||||||
| Parameter | ||||||||
| (mm) | Diameter: Min 8.0 | |||||||
| Gingival Collar Height: Min | ||||||||
| 2.0 | ||||||||
| Post Height: Min 7.0 | unknown | unknown | Diameter: Min 8.0 | |||||
| Gingival Collar | ||||||||
| Height: Min 2.0 | ||||||||
| Post Height: Min 7.0 | Diameter: Min 8.0 | |||||||
| Gingival Collar | ||||||||
| Height: Min 2.0 | ||||||||
| Post Height: Min 7.0 | NA | |||||||
| Abutment | ||||||||
| Material | Ti-6Al-4V ELI | Titanium Alloy | Unalloyed | |||||
| Titanium | ||||||||
| ASTM F67 | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | |||||
| Sterilization | Non-sterile; intended for | |||||||
| terminal sterilization via | ||||||||
| autoclave | Non-sterile | Non-sterile | Non-sterile; | |||||
| intended for | ||||||||
| terminal | ||||||||
| sterilization via | ||||||||
| autoclave | Non-sterile; | |||||||
| intended for | ||||||||
| terminal | ||||||||
| sterilization via | ||||||||
| autoclave | Non-sterile; | |||||||
| intended for | ||||||||
| terminal | ||||||||
| sterilization | ||||||||
| via autoclave | ||||||||
| Abutment | ||||||||
| Diameter (mm) | 10, 12 | 3.0~7.0 | Unknown | 3.8~10.0 | 3.0~3.5 | 3.8 | ||
| Octa Abutment | ||||||||
| Interface | ||||||||
| Abutment | ZrGEN Abutment | |||||||
| (Octa level) and Zirconia top- | ||||||||
| half is used with Octa | ||||||||
| Abutment | ||||||||
| Image: Zirconia top-half | ||||||||
| Image: ZrGEN Abutment | ||||||||
| Image: Octa Abutment | ||||||||
| Image: Fixture | Unknown | Unknown | Gold Cylinder | |||||
| Plastic Cylinder and | ||||||||
| CCM Cylinder, EZ | ||||||||
| Post Cylinder are | ||||||||
| used with Octa | ||||||||
| Abutment. | ||||||||
| Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | Gold Cylinder | |||||||
| Plastic Cylinder and | ||||||||
| CCM Cylinder, EZ | ||||||||
| Post Cylinder are | ||||||||
| used with Octa | ||||||||
| Abutment. | ||||||||
| Image: Gold Cylinder Plastic Cylinder and CCM Cylinder, EZ Post Cylinder are used with Octa Abutment. | NA | |||||||
| Platform | ||||||||
| Diameter | ||||||||
| (mm) | -Standard Type, C-Type | |||||||
| : 2.31, 2.8, 3.1, 3.3 | ||||||||
| -Octa Level Type | ||||||||
| : 3.8, 4.0, 4.8, 5.0, 5.8, 6.0 | Unknown | 3.1 | 3.1, 3.3 | 2.31 | ||||
| Fixture | ||||||||
| Diameter | ||||||||
| (mm) | Standard Type, С-Туре | |||||||
| 3.5, 4.0, | ||||||||
| XPEED | ||||||||
| 4.5, 5.0, | ||||||||
| AnyRidge | ||||||||
| 5.5, 6.0, | ||||||||
| Internal | ||||||||
| 6.5, 7.0, | ||||||||
| Implant System | ||||||||
| 7.5, 8.0 | 3.3~7.0 | 3.6-7.0 | Internal type: | |||||
| 4.0, 4.4, 4.9, 5.4, 5.9 | ||||||||
| (For normal ridge) | ||||||||
| 6.4, 6.9, 7.4, 7.9, 8.4 | ||||||||
| (For low ridge) | Internal type: | |||||||
| 3.9, 4.3, 4.8, 5.3, | ||||||||
| 6.3, 7.3 | ||||||||
| (For normal ridge) | ||||||||
| 4.8, 5.8, 6.8, 7.8, 8.3 | ||||||||
| (For deep Thread) | ||||||||
| 4.8, 5.3, 6.3, 7.3 | Internal Type; | |||||||
| 3.0~3.5 |
12
| AnyOne
Internal
Implant System | 3.5, 4.0,
4.5, 5.0,
6.0, 7.0,
7.5, 8.0 | (For special length) |
|-------------------------------------------------|--------------------------------------------------------------|----------------------|
| MiNi Internal
Implant System | 3.0, 3.25 | |
| AnyRidge Octa
1 Implant
System | 3.6, 3.7,
4.0, 4.1,
4.4, 4.8,
5.0, 5.5 | |
| Octa Level Type | | |
| XPEED
AnyRidge
Internal
Implant System | 3.5, 4.0,
4.5, 5.0,
5.5, 6.0,
6.5, 7.0,
7.5, 8.0 | |
| AnyOne
Internal
Implant System | 3.5, 4.0,
4.5, 5.0,
6.0, 7.0,
7.5, 8.0 | |
| AnyRidge Octa
1 Implant
System | 3.6, 3.7,
4.0, 4.1,
4.4, 4.8,
5.0, 5.5 | |
| Substantial Equivalence Discussion | | |
1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device, K150203.
- Indications for use, Abutment Design, Restoration, Abutment/Implant Interface, Abutment Material.
2. Differences
The subject device has the different characteristic for the followings compared to the predicate device, K150203. For Abutment Angle, the subject device is a straight type but predicate has angulation.
For Fop-half Material, Range of Top-half Design Parameter, Octa Abutment. It can be covered by the reference device.
3. Discussion
The subject device and predicate device, K150203, are used for support of CAD/CAM fabricated zirconia superstructures. The subject device and predicate device have common as following: Indications for use, Abutment/Implant Interface and Abutment Material. The ZrGEN Abutment and the top-half of ZrGEN Abutment is a straight type without angulation, so the fating is not considered.
Based on the information based in submission, it is concluded that the substantially equivalent to the predicate device.
13
7.2.3 Scan Healing Abutment
| Subject Device | Reference Device | ||
|---|---|---|---|
| 510(k) Number | K220562 | K110955 | K173374 |
| Device Name | Scan Healing Abutment | Healing Abutment | |
| for AnyRidge Internal System | TSV™ BellaTek Encode Healing | ||
| Abutment | |||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Biomet 3i |
| Appearance | Image: Scan Healing Abutment | Image: Healing Abutment for AnyRidge Internal System | Image: TSV BellaTek Encode Healing Abutment |
| Diameter(mm) | 4.2, 4.7, 5.7, 6.7 | 4.2, 5.2, 6.2, 7.2, 8.0, 10.0 | 3.5, 4.5, 5.7 |
| Gingival height(mm) | 3.8, 4.5, 4.8, 5.5, 6.5, 6.8 | 3.5, 4.5, 5.5, 6.5,7.5 | 3, 5, 7 |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Shelf Life | 5 years | 5 years | 5 years |
| Connection | |||
| Interface | Internal Conical connection | Internal Conical connection | Internal |
| Surface treatment | Color Anodization | Machined | Machined |
| Principle of | |||
| operation | The Scan Healing Abutment is used for | ||
| non-submerged type surgery or for | |||
| two-stage surgery. The healing | |||
| abutment is fixated on the implant | |||
| using a retaining screw immediately | |||
| after implant placement in a one-stage | |||
| surgical protocol. In a two-stage | |||
| surgical protocol, the healing abutment | |||
| is fixated on the implant following the | |||
| bone healing period. The soft tissue is | |||
| sutured around the healing abutment | |||
| and the device remains in the mouth | |||
| until the soft tissue fully develops. And | |||
| it is a scannable that can help with the | |||
| impression intraoral without removal. | The Healing Abutment is fastened into the | ||
| female screw of dental implant and | |||
| supports the gingival shaping. | The TSV™ BellaTek Encode Healing | ||
| Abutment aids in prosthetic | |||
| rehabilitation by supporting the | |||
| surrounding gingival tissue during the | |||
| healing period. The healing abutment is | |||
| fixated on the implant using a retaining | |||
| screw immediately after implant | |||
| placement in a one-stage surgical | |||
| protocol. And two-stage surgical | |||
| protocol, the healing abutment is | |||
| fixated on the implant following the | |||
| bone healing period. The soft tissue is | |||
| sutured around the healing abutment | |||
| and the device remains in the mouth | |||
| until the soft tissue fully develops. The | |||
| occlusal surface of the device includes | |||
| machined markings that provide | |||
| information about the mating implant's | |||
| position and orientation. | |||
| Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
| Substantial Equivalence Discussion |
1. Similarities
The subject device has the same characteristic for the followings compared to the reference device, K173374.
- Indications for use, Sterilization, Shelf Life, Connection, Surface treatment, Principle of operation and Material.
The sterilization method is the same as the reference device, K110955.
2. Differences
The subject device has the different characteristic for the followings compared to the reference devices.
- Appearance
The subject device is two-piece type so used with abutment screw. And upper could be used Scan Post with. But reference devices are one-piece type.
- Diameter and Gingival Height
Diameter and gingival height of subject device lies within the dimension range of the reference devices.
3. Discussion
The Subject device and reference device have common in Indication, Connection, Surface treatment, Principle of operation and Material. And the differences are Appearance, Diameter and Gingival Height. But These do not affect device's performance and functionality. The Sterlization validating testing has been performed in accordance with ISO 11765-1, 2 to verify the sterility assurance level (10-6) under the previous 510(k) submission, K110955. The tests to validate the shelf life of the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shellization validation of nonsterile subject device can be leveraged with reference device, K110955.
Based on the information based in submission, we conclude that the substantially equivalent to the reference devices.
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8. Summary of Non-Clinical Testing
The non-clinical testing data which are submitted, referenced, or relied on in this submission support demonstrating substantial equivalence.
Sterilization validation
The TiGEN Abutment and ZrGEN Abutment are supplied in non-sterile state. For TiGEN Abutment, sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 17665-1 and ISO 17665-2 to verify the sterility assurance level (10.9) under the previous 510(k) submission, K182448. Therefore, it was leveraged from the prior cleared Abutment and Screw of K182448.
For ZrGEN Abutment, the steam sterilization of ZrGEN Abutment cemented Zirconia top-half has been carried out according to the protocol related to the requirements for validation described in ISO 17665-1 and ISO 17665-2.
The Scan Healing Abutment is supplied in sterile state. The sterilization validating testing has been performed in accordance with ISO 1137 to verify the sterility assurance level (106) under the previous 510(k) submission, K110955. The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 years shelf life. The sterilization of the supplied sterile subject device can be leveraged with reference device, K110955.
Pyrogen and Endotoxin Test
The Scan Healing Abutment will not be labeled as "non-pyrogenic", and the endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL in accordance with the USP 39.
Biocompatibility
For TiGEN Abutment, the biocompatibility evaluation has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" under the previous cleared K182448. As the TiGEN Abutment has same material and surface treatment as the FDA prior cleared, so it was leveraged from the prior cleared devices and the additional biocompatibility testing is not required. For ZrGEN Abutment, the biocompatibility evaluation of ZrGEN Abutment construct has been performed in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Cytotoxicity was performed according to ISO 10993-5 determining the subject device is non-cytotoxic. For Scan Healing Abutment, the biocompatibility evaluation has been performed in accordance with
International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" under the previous 510k(k) submission, K182448. As the Scan Healing abutment has same material and surface treatment as the FDA prior cleared, so it was leveraged from the prior cleared devices and the additional biocompatibility testing is not required.
Performance Test
Fatigue testing was performed on the worst-case TiGEN Abutment and compatible implant fixture constructs according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants.
Accelerated shelf life Test
The accelerated shelf life study was performed in accordance with ASTM F1980 and it was leveraged from the prior cleared Healing Abutment of K110955.
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MR Compatibility
Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (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.
9. Summary of Clinical Testing
No clinical studies are submitted.
10. Conclusion
Based on the similarities, we conclude that the TIGEN Abutment and Scan Healing Abutment are substantially equivalent to the predicate device.