MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
Device Facts
| Record ID | K233450 |
|---|---|
| Device Name | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw |
| Applicant | Megagen Implant Co., Ltd. |
| Product Code | NHA · Dental |
| Decision Date | Jan 22, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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 patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.
Device Story
Device consists of various dental implant abutments and associated screws (Scan Healing Abutment, Temporary Abutment/Cylinder, Comfort Cap, Healing Cap, Milling Abutment, EZ Post Abutment/Cylinder, ZrGEN Abutment, Multi-unit Abutment, AXA Abutment). Inputs include patient-specific anatomical data for digitally designed abutments; physical fixture connection. Operation involves surgical placement of abutment into dental implant fixture; support for provisional or final prosthetic restorations. Used in dental clinics by clinicians. Output is prosthetic support for crowns/bridges. Benefits include restoration of chewing function and gingival healing. ZrGEN abutments require off-site milling at validated centers. Healthcare providers use output to finalize dental restorations; clinical decision-making based on patient edentulism and prosthetic needs.
Clinical Evidence
No clinical data submitted. Substantial equivalence supported by bench testing (ISO 14801 fatigue testing) and biocompatibility data from previously cleared MegaGen devices (K182448, K231967).
Technological Characteristics
Materials: Ti-6Al-4V ELI (ASTM F136-13), POM, Zirconia (K051705). Connection: Internal Hex, Octa, or Conical. Surface: Machined or Anodized. Sterilization: Gamma irradiation (Scan Healing Abutment) or user-performed steam sterilization. Form factor: Various abutment geometries for prosthetic support.
Indications for Use
Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular areas to restore chewing function.
Regulatory Classification
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.
Special Controls
*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.)
Predicate Devices
- AnyRidge Internal Implant System (K110955)
Reference Devices
- XPEED AnyRidge Internal Implant System (K122231)
- AnyOne Internal Implant System (K123988)
- BLUEDIAMOND Implant System (K182448)
- Multi-unit Abutment System (K203808)
- Healing Abutment, Cover Screw (K210826)
- BLUDIAMOND IMPLANT, Abutment Screw (K211812)
- TiGEN, ZrGEN, Scan Healing Abutment (K220562)
- BHdental Implant System (K103280)
- NobelProcera Angulated Screw Channel Abutment Replace (K133377)
- ARi ExCon Implant System (K231967)
Related Devices
- K242030 — MegaGen Dental Implant Abutment · Megagen Implant Co., Ltd. · Jan 13, 2025
- K243212 — DESS Dental Smart Solutions · Terrats Medical SL · Feb 14, 2025
- K231753 — Oneday Implant Abutment · Oneday Biotech Co., Ltd. · Feb 21, 2024
- K212517 — Magicore System · Innobiosurg Co., Ltd. · Oct 15, 2021
- K191986 — DESS Dental Smart Solutions · Terrats Medical SL · Nov 10, 2019
Submission Summary (Full Text)
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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 and 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, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
January 22, 2024
MegaGen Implant Co., Ltd. Seo MinGi 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun Daegu, 42921 REPUBLIC OF KOREA
# Re: K233450
Trade/Device Name: MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II Product Code: NHA Dated: October 20, 2023 Received: October 20, 2023
Dear Seo MinGi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
{2}------------------------------------------------
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
# 510(k) Number (if known) K233450
#### Device Name
MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Cylinder; Comfort Cap; Healing Cap: Healing Cap Screw; Milling Abutment; EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
#### Indications for Use (Describe)
MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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 patients chewing function.
All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.
| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td style="border:none"><div style="display:inline-block;"> <input type="checkbox"/> Research Use Only (For all OFF-MYCis Plasmids) </div></td><td style="border:none"><div style="display:inline-block;"> <input type="checkbox"/> Gene Therapy Use (For OFF-MYCis Plasmids Only) </div></td></tr></table> | <div style="display:inline-block;"> <input type="checkbox"/> Research Use Only (For all OFF-MYCis Plasmids) </div> | <div style="display:inline-block;"> <input type="checkbox"/> Gene Therapy Use (For OFF-MYCis Plasmids Only) </div> |
| <div style="display:inline-block;"> <input type="checkbox"/> Research Use Only (For all OFF-MYCis Plasmids) </div> | <div style="display:inline-block;"> <input type="checkbox"/> Gene Therapy Use (For OFF-MYCis Plasmids Only) </div> | |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# General Summary of Submission
# 510(k) Summary for K233450
Date: January 22, 2024
# 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
MinGi Seo MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3892 Fax: +82-53-247-2254 Email: ra14@imegagen.com
# 3. Device
| | • Trade Name: | MegaGen Dental Implant Abutment - Scan Healing Abutment;<br>Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap;<br>Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post<br>Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment;<br>Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment<br>(Angled); Abutment Screw; Cylinder Screw; Crown Screw |
|--|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • 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:
K110955 AnyRidge Internal Implant System
#### . Reference Devices:
K122231 XPEED AnyRidge Internal Implant System K123988 AnyOne Internal Implant System K182448 BLUEDIAMOND Implant System K203808 Multi-unit Abutment System K210826 Healing Abutment, Cover Screw K211812 BLUDEDIAMOND IMPLANT, Abutment Screw K220562 TiGEN, ZrGEN, Scan Healing Abutment
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K103280 BHdental Implant System K133377 NobelProcera Angulated Screw Channel Abutment Replace K231967 ARi ExCon Implant System
# 5. Description
#### . Scan Healing Abutment
The Scan Healing Abutment is intended for use as accessory to endosseous dental implants during endosseous and gingival healing to prepare gingival tisue for acceptance of a final abutment and restoration. It is used for non-submerged type surgery or for two-stage surgery. It is made of Ti-6AI-4V-EL, and offered in machined and anodizing surface. It is supplied using gamma irradiation during manufacturing process. It is single use devices.
| Device | Component |
|--------------------------|----------------------------------------------------------------------------------------------------------------|
| Scan Healing<br>Abutment | XPEED AnyRidge Internal Implant System<br>$ \varnothing $ 4.7, 5.7 x 6.9, 7.9, 9.9, 11.9mm |
The Scan Healing Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
# Temporary Abutment
The Temporary Abutment is used in conjunction with fixture to provisional restoration and connected to the Fixture with Abutment Screw. It has knurled surface on the top part, which allows for better retention of resin or wax. It is not customizable but used as it is. The Temporary Abutment is supplied non-sterilized by the user according to the IFU and intended for single use.
### The dimensions of Temporary Abutment are follows:
| Device | Component |
|-----------------------|-------------------------------------------------------------------------------------------|
| Temporary<br>Abutment | XPEED AnyRidge Internal Implant System<br>$Ø$ 4.2, 4.7, 5.7, 6.7 x 6.9, 7.9, 9.9, 11.9 mm |
| | BLUEDIAMOND IMPLANT System<br>$Ø$ 4.2, 4.7, 5.7, 6.7 x 12.35, 13.85 mm |
The Temporary Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|-----------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5 |
Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.
*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.
- · Temporary Cylinder
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The Temporary Cylinder is used in conjunction with Muti-unit Abutment or AXA Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw. It has knurled surface on the top part (Post Cylinder), which allows for better retention of resin or wax. This component is not customizable but used as it is.
The dimensions of Temporary Cylinder are follows:
| Device | Component |
|-----------------------|---------------------------------------|
| Temporary<br>Cylinder | Common<br>$\phi$ 4.8, 4.9, 5.7 x 12mm |
#### Comfort Cap .
Comfort Cap is used for protecting a Solid Abutment after taking iminimizing irritation to tongue and oral mucosa. It easily makes a temporary crown by resin build up.
The dimensions of Comfort Cap are follows:
| Device | Component |
|-------------|-------------------------------------|
| Comfort Cap | Common<br>$\varnothing$ 5.0 x 5.4mm |
#### . Healing Cap
The Healing Cap is intended to be used during intra-oral soft tissue healing to protect the Multi-unit Angled Abutments or AXA Abutment (Straight, Angled) and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It is a two-piece type, connected to the abutment with Cylinder Screw. The Healing Cap is a temporary component used for soft tissue healing.
The dimensions of Healing Cap are follows:
| Device | Component |
|-------------|-----------------------------------------------------|
| Healing Cap | Common |
| | $\varnothing$ 6.8 x 4.2, 5.5 mm |
| | $\varnothing$ 4.9 x 5.5 mm |
| | $\varnothing$ 5.0, 5.5, 6.0, 6.1, 6.5 x 6.0, 8.0 mm |
#### . Healing Cap Screw
Healing Cap Screw is used for connecting AXA Abutment (Straight) or AXA Abutment (Angled) to Healing Cap. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Healing Cap Body Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
The dimensions of Healing Cap are follows:
| Device | Component |
|----------------------|--------------------------------------|
| Healing Cap<br>Screw | Common<br>$\varnothing$ 2.5 x 3.3 mm |
### - Milling Abutment
The Milling Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis and used for establishing an adequate safety margin from occlusal line by hand milling of the post part. It is connected to the Fixture with Abutment Screw. The Milling Abutment can be modified in post height only (The minimum post height is 4mm above the abutment collar/gingival height). The Milling abutment is supplied non-sterilized by the user according to the IFU and intended for single use.
The dimensions of Milling Abutment are follows:
| Device | Component |
|---------------------|----------------------------------------------------------------------|
| Milling<br>Abutment | XPEED AnyRidge Internal Implant System<br>$\varnothing$ 4.0 x 22.4mm |
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| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|-----------------|-----------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
The Milling Abutment is compatible with following MegaGen Implants cleared under:
#### . EZ Post Abutment/Extra EZ Post Abutment
The EZ Post Abutment is used in conjunction with fixture to provide support for cement and screw retained type final prosthesis. It is connected to the Fixture with Abutment Screw. It is made of Ti-6AI-4V-ELI, and offered in machined, anddizing blue, gold, brown and green. The EZ Post abutment is supplied non-sterilized by the user according to the IFU and intended for single use.
The dimensions of EZ Post Abutment are follows:
| Device | Component |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | XPEED AnyRidge Internal Implant System<br>Ø 5.0 x 12.9mm<br>Post Height: 5.5mm |
| EZ Post<br>Abutment<br>/Extra EZ Post<br>Abutment | BLUEDIAMOND IMPLANT System<br>Ø 4.0, 5.0 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85,12.35, 12.85, 13.35, 13.85, 14.85mm<br>Ø 6.0, 7.0 x 9.35, 10.35, 10.85, 11.35, 11.85,12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35, 16.35mm<br>Post Height: 4.0, 7.0 mm |
The EZ Post Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| MegaGen<br>Implant Co.,<br>Ltd. | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5, 5.6, 6.0, 6.5, 7.0 |
[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.
*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.
#### EZ Post Cylinder .
The EZ Post Cylinder is used in conjunction with Multi-unit Abutment or Multi-unit Angled Abutment to provide support for provisional restoration and used for fabricating the single and multi-unit prosthesis. It is connected to the Abutment with Cylinder Screw.
The dimensions of EZ Post Cylinder are follows:
| Device | Component |
|------------------|--------------------------------------------------------------------------------------------------------|
| | Common |
| EZ Post Cylinder | Ø 4.8, 4.9, 5.7 x 4.2, 5.5, 5.8, 7.0, 9.0 mm<br>Post Height (Total Length) : 4.2, 5.5, 5.8 7.0, 9.0 mm |
### · ZrGEN Abutment
The titanium base is not milled but will be used as it is. The titanium base will be cemented Zirconia top-haff with FDA-cleared Dental cement (Kuraray Noritake Dental - PANAVIATM SA Cement Universal Automix, K183537). The ZrGEN Abutment is intended to be sent to a MegaGen-validated milling center for manufacturing Zirconia top-half and for cementing with Zirconia top-half (IVOCLAR VIVADENT, INC. - IPS E.MAX CAD/IPS E.MAX ZIRCAD, K051705).
{8}------------------------------------------------
The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia tophalf to complete the final finished device. This abutment is to be used only with implants placed straight.
| | | | The dimensions of ZrGEN Abutment are follows: | |
|--|--|--|-----------------------------------------------|--|
|--|--|--|-----------------------------------------------|--|
| Device | Component |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| ZrGEN<br>Abutment | XPEED AnyRidge Internal Implant System<br>Ø 4.5, 5.0, 5.5, 6.0 x 7.5, 8.6, 9.0, 10.1, 11.0, 11.4, 12.4, 13.4, 14.4 mm |
| | BLUEDIAMOND IMPLANT System<br>Ø 4.4, 4.5 x 6.45, 7.35, 7.95, 8.85, 9.85, 9.95, 10.35, 10.85, 11.35, 13.35 mm |
| | Common<br>Ø 4.8 x 5.5, 6.5, 8.5 mm |
The allowable ranges of design parameters after CAD/CAM patient-matching are follows:
| Zirconia top-half | Minimum wall thickness (mm) | 0.5 |
|-------------------|-------------------------------------------------------------------|-----|
| | Maximum angulation (°) | 0 |
| | Minimum gingival collar (ø) | 8 |
| | Maximum gingival collar (ø) | 10 |
| | Minimum Gingival collar height (mm) | 2 |
| | Maximum Gingival collar height (mm) | 5 |
| | Minimum post height above the abutment collar/gingival height(mm) | 7 |
| | Maximum post height above the abutment collar/gingival height(mm) | 15 |
The ZrGEN Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| MegaGen<br>Implant Co.,<br>Ltd. | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5, 5.6, 6.0, 6.5, 7.0 |
[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.
*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.
### Multi-unit Abutment
The Multi-unit Abutment is a straight type, the lower part is intended to the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.
The Multi-unit Abutment is a one-piece type and not contained an anti-rotational feature, allowing the abutment to be screwed directly in to the endosseous dental implant by their lower thread part. The thread part has three types of male screws depending on the fixture system to be connected. The Multi-unit is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
| Device | Component |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multi-unit Abutment | XPEED AnyRidge Internal Implant System<br>$\varnothing$ 4.8 x 12.75, 13.75 mm<br>BLUEDIAMOND IMPLANT System<br>$\varnothing$ 4.8 x 14.8, 13.8 mm<br>AnyOne Internal Implant System<br>$\varnothing$ 4.8 x 13.84, 14.84 mm |
The dimensions of Multi-unit Abutment are follows:
The Multi-unit Abutment is compatible with following MegaGen Implants cleared under:
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| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|--------------------|------------------|-----------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5 |
(Note) There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.
*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.
### Multi-unit Angled Abutment
The Multi-unit Angled Abutment is an angled type, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.
The Multi-unit Angled Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Multi-unit Abutment Screw. The Multi-unit is an angled type and available in 17° and 30°. The Multi-unit Angled Abutment is compatible with the prosthet in this submission. The Multi-unit Angled Abutment is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
#### The dimensions of Multi-unit Abutment are follows:
| Device | Component |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multi-unit<br>Angled<br>Abutment | XPEED AnyRidge Internal Implant System<br>Ø 4.8 x 7.4, 7.9, 8.4, 8.9 mm<br>BLUEDIAMOND IMPLANT System<br>Ø 4.8 x 8.35, 9.35, 9.85, 10.85 mm<br>AnyOne Internal Implant System<br>Ø 4.8 x 7.94, 8.94 mm |
The Multi-unit Abutment, Multi-unit Angled Abutment is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|--------------------|------------------|-----------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5 |
[Note] There is the modification of the Implant System Name for FDA cleared AnyRidge Octa 1 Implant System to BLUEDIAMOND IMPLANT System with K182448. According to below FDA Guidance*, MEGAGEN manages it as a 510(k) VARIANCE REQIEST FORM for changes.
*Deciding When to Submit a 510(k) for a Change to an Existing Device / Guidance for Industry and Food and Drug Administration Staff / Document issued on October 25, 2017.
### · AXA Abutment (Straight)
The straight type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis.
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The dimensions of AXA Abutment (Straight) are follows:
| Device | Component |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AXA Abutment<br>(Straight) | XPEED AnyRidge Internal Implant System<br>Ø 4.0, 5.0 x 11.05, 12.05, 13.05, 15.05, 17.05, 19.05 mm<br>BLUEDIAMOND IMPLANT System<br>Ø 4.0, 5.0 x 12.10, 13.10, 14.10, 16.10, 18.10, 20.10 mm<br>AnyOne Internal Implant System<br>Ø 4.0, 5.0 x 12.143, 13.143, 14.143, 16.143, 18.143, 20.143 mm |
The AXA Abutment (Straight) is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5, 5.6, 6.0, 6.5, 7.0 |
# ▪ AXA Abutment (Angled)
The angled type of AXA Abutment, the lower part is intended to be placed on the endosseous dental implant and the top part is connected Healing Cap, Impression Coping or Cylinders, such as Temporary Cylinder with the Screw to fabricate temporary or final prosthesis. The angled type of AXA Abutment is a two-piece type, contained an anti-rotational feature, and connected to the endosseous dental implant by Abutment Screw. There are two connection types: the internal hex/octa type and the non-hex/non-octa type.
The dimensions of AXA Abutment (Angled) are follows:
| Device | Component |
|--------------------------|--------------------------------------------------------------------------|
| AXA Abutment<br>(Angled) | XPEED AnyRidge Internal Implant System<br>Ø 4.0, 5.0 x 6.4, 8.4, 10.4 mm |
| | BLUEDIAMOND IMPLANT System<br>Ø 4.0, 5.0 x 6.85, 8.85, 10.85 mm |
| | AnyOne Internal Implant System<br>Ø 4.0, 5.0 x 6.64, 8.64, 10.64 mm |
### The AXA Abutment (Angled) is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|------------------------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixure | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5.<br>5.6, 6.0, 6.5, 7.0 |
### · Abutment Screw
The Abutment Screw is used for connecting abutment for each Implant System. The lower part has male screws depending on the fixture system to be connected. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Abutment Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
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The dimensions of Abutment Screw are follows:
| Device | Component |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment Screw | XPEED AnyRidge Internal Implant System<br>Ø 2.0 x 8.5, 9.45, 11.45 mm<br>BLUEDIAMOND IMPLANT System<br>Ø 2.2 x 9.9, 7.9 mm<br>AnyOne Internal Implant System<br>Ø 2.1 x 9.6, 10.6, 12.6 mm |
The Abutment Screw is compatible with following MegaGen Implants cleared under:
| Manufacturer | Compatible Implant<br>System | Device Name | 510(k)<br>Number | Connection | Diameter (mm) |
|---------------------------------|----------------------------------------------|------------------------------------|------------------------------------------|------------------|---------------------------------------------------------------|
| MegaGen<br>Implant Co.,<br>Ltd. | XPEED AnyRidge<br>Internal Implant<br>System | XPEED AnyRidge<br>Internal Fixture | K110955<br>K122231<br>K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9,<br>7.4, 7.9, 8.4 |
| | AnyOne Internal<br>Implant System | AnyOne Internal<br>Fixture | K123988 | Internal Hex | 3.9, 4.3, 4.8, 5.3, 5.8, 6.3, 6.8,<br>7.3, 7.8, 8.3 |
| | BLUEDIAMOND<br>IMPLANT System | BLUEDIAMOND<br>IMPLANT | K182448<br>K211812 | Internal<br>Octa | 3.6, 3.7, 4.0, 4.1, 4.4, 4.8, 5.0,<br>5.5, 5.6, 6.0, 6.5, 7.0 |
#### . Cylinder Screw
Cylinder Screw is used for connecting Multi-unit Abutment or Multi-unit Angled Abutment to Healing Cap, Temporary cylinder or EZ Post Cylinder. It is made of Ti-6AI-4V-ELI and offered in machined surface. The Cylinder Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
The dimensions of Cylinder Screw are follows:
| Device | Component |
|----------------|--------------------------------------|
| Cylinder Screw | Common<br>$\varnothing$ 2.1 x 4.9 mm |
### - Crown Screw
The Crown Screw is a prosthetic component connected to abutment and in prosthetic rehabilitation. It is made of Ti-6AI-4V-ELI and offered in machined surface. The crown Screw is supplied non-sterile, to be sterilized by the user according to the IFU and intended for single use.
The dimensions of Crown Screw are follows:
| Device | Component |
|-------------|--------------------------------------------|
| Crown Screw | Ø 2.3, 2.4 x 5.2, 7.0mm<br>Ø 2.1 x 4.65 mm |
# 6. Indications for use
The MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular 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 patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.
#### 7. Basis for Substantial Equivalence
The MegaGen Dental Implant Abutment is substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are material and have similar design. The size range of the subject of the subject device slightly differ from the predicate device however it is very minor not
{12}------------------------------------------------
affecting substantial equivalence.
Based on the comparison charts below and test results provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.
### (1) Scan Healing Abutment
| | Subject Device | Predicate device | Reference Device |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | - | K110955 | K220562 |
| Device Name | Scan Healing Abutment | Healing Abutment | Scan Healing Abutment |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for<br>Use Statement | The MegaGen Dental Implant Abutment<br>is intended to be surgically placed in the<br>maxillary or mandibular areas for the<br>purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patients chewing function. All<br>digitally designed abutments for use<br>with ZrGEN Abutment are intended to be<br>sent to a MegaGen validated milling<br>center for manufacture. | The AnyRidge Internal Implant System is<br>intended to be surgically placed in the<br>maxillary or mandibular molar areas for<br>the purpose providing prosthetic support<br>for dental restorations (Crown, bridges,<br>and overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing function.<br>Smaller implants (less than Ø6.0 mm) are<br>dedicated for immediate loading when<br>good primary stability is achieved and<br>with appropriate occlusal loading. Larger<br>implants are dedicated for the molar<br>region and are indicated for delayed<br>loading. | Scan Healing Abutment is intended for<br>use on endosseous dental implants in<br>the edentulous or partially edentulous<br>maxilla or mandible, as an aid in<br>prosthetic rehabilitation. |
| Design | Image: Scan Healing Abutment | Image: Healing Abutment | Image: Scan Healing Abutment |
| Diameter (Ø) | 4.7, 5.7 mm | 4.2, 5.2, 6.2, 7.2, 10.0 mm | 4.2, 4.7, 5.7, 6.7 mm |
| Gingival Height | 2.4, 3.4, 5.4, 7.4 mm | 3.5, 4.5, 5.5, 6.5, 7.5 mm | 2.4, 3.4, 5.4, 7.4 mm |
| Total Length | 6.9 ~ 11.9 mm | 8.4 ~ 14.4 mm | 6.9 ~ 11.85mm |
| Connection<br>Interface | Internal Conical Connection | Internal Conical Connection | Internal Conical Connection |
| Material | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) | Ti-6A1-4V ELI(ASTM F136-13) |
| Surface<br>Treatment | Anodizing | Machined | Anodizing |
| Single Use | Yes | Yes | Yes |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Shelf-life | 5 years | 5 years | 5 years |
| Principle of<br>Operation | The Scan Healing Abutment is fastened<br>into the female screw of dental implant<br>and support the gingival shaping. And it<br>is a scannable that can help with the<br>impression intraoral without removal. | The Healing Abutment is fastened into<br>the female screw of dental implant and<br>support the gingival shaping. | The Scan Healing Abutment is fastened<br>into the female screw of dental implant<br>and support the gingival shaping. And it<br>is a scannable that can help with the<br>impression intraoral without removal. |
| Compatible<br>Implant<br>System | XPEED AnyRidge Internal Implant System | XPEED AnyRidge Internal Implant System | XPEED AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>BLUEDIAMOND IMPLANT System |
| Substantial Equivalence Discussion | | | |
### 1. Similarities
The subject device has the same characteristic for the followings compared to the predicate device.
- Indications for Use, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Shelf Life, Principle of Operation
#### 2. Difference
The subject device has the different characteristics for the followings compared to the predicate device.
- Total Length
The total length of the subject device (11.9 mm) is longer than the reference device and other lengths are within range of the reference device. Since this size difference is very minor it does not cause a matter in substantial equivalence. And the total length includes the connection length of each implant system and therefore does not affect substantial equivalence.
{13}------------------------------------------------
### 3. Discussion
The Subject device and predicate device have common in Indications for sue, Design, Diameter, Gingival Height, Connection Interface, Material, Surface Treatment, Single Use, Sterilization, Shelf Life and Principle of Operation. And the difference is only the total Length. But these do not affect device's substantial equivalence. Also, the subject device is intended for temporary use.
- Based on the information in the submission, it is concluded that the subject device is substantially equivale device.
{14}------------------------------------------------
### (2) Temporary Abutment
| | Subject Device | Predicate Device | Reference Device1 | Reference Device2 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | - | K110955 | K182448 | K203808 |
| Device Name | Temporary Abutment…
