Healing Abutment, Cover Screw

K210826 · Megagen Implant Co., Ltd. · NHA · Feb 3, 2022 · Dental

Device Facts

• Record ID: K210826
• Device Name: Healing Abutment, Cover Screw
• Applicant: Megagen Implant Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Feb 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Device Story

Healing Abutment and Cover Screw aid in prosthetic rehabilitation; Healing Abutment shapes soft tissue emergence profile during gingival healing; Cover Screw protects inner fixture structure during submerged surgery. Devices are metallic, inserted into endosseous dental implants by dentists/clinicians in clinical settings. Healing Abutments come in Incisor, Canine, Molar, and Special types. Scan Healing Abutment Screw connects abutment to implant. Output is physical tissue contouring and fixture protection. Benefits include improved emergence profile for final restoration and protection of implant platform. No software or AI involved.

Clinical Evidence

No clinical data. Evidence relies on bench testing, including biocompatibility (ISO 10993-1), sterilization validation (ISO 11137), shelf-life testing (ASTM F1980), and precision fit testing.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136-13). Design: Straight abutments and screws for internal hex/octa connections. Sterilization: Gamma irradiation. Shelf life: 5 years. No software or electronic components.

Indications for Use

Indicated for prosthetic rehabilitation in patients requiring dental implant abutments. Contraindications include patients where the device cannot be properly placed or where the patient's oral environment is unsuitable for the specific abutment type.

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

• Healing Abutments and Cover Screws (K192436)

Reference Devices

• AnyRidge Internal Implant System (K110955)
• AnyOne™ Internal Implant System (K123988)
• AnyRidge Octa 1 Implant System (K182448)
• IS-III active System (K181138)
• MiNi Internal Implant System (K150537)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

MegaGen Implant Co., Ltd. % Hyo Eun Lee Research Engineer DaeGyeong Regulatory Affairs Institute 32. Innovallev-ro Daegu, Dong-gu 41065 REPUBLIC OF KOREA

Re: K210826

Trade/Device Name: Healing Abutment, Cover Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 28, 2021 Received: January 5, 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K210826

Device Name Healing Abutment, Cover Screw

Indications for Use (Describe) MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.

| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | | | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
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| FABILEBI AGAL (AIAA | D--- 1 -- 1 -- 1 | | | | | |

Type of Use (Select one or both, as applicable)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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## 510(k) Summary for K210826

## Date: February 3, 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 DaeGyeong Regulatory affairs Institute 32, Innovalley-ro, Dong-gu, Daegu, Republic of Korea Tel: [phone] Fax: [phone] Email: [e-mail]

### 3. Device

- Trade Name: Healing Abutment, Cover Screw
- Endosseous dental implant abutment
- Classification Name:

Common Name:

Endosseous dental implant abutment

- . Classification Product Code:
- NHA Class II, 21 CFR 872.3630 Classification regulation:

## 4. Predicate Device

.

•

- Primary Predicate Device: .
K192436 - Healing Abutments and Cover Screws

#### Reference Device: .

K110955 – AnyRidge Internal Implant System K123988 – AnyOne™ Internal Implant System K182448 – AnyRidge Octa 1 Implant System K181138 - IS-III active System K150537 – MiNi Internal Implant System

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### 5. Description

The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant.

The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment.

Image /page/4/Figure/3 description: The image shows four different types of dental abutments. The abutments are labeled as "Incisor type", "Canine type", "Molar type", and "Special type". Each abutment has a different shape and size, which is designed to fit different teeth. The abutments are made of a metallic material and have a hole in the top for attaching a dental crown.

The Healing Abutment and Scan Healing Abutment screw are 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 System | Xpeed AnyRidge<br>Internal Fixture | K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9,<br>6.4, 6.9, 7.4, 7.9, 8.4 |
| | AnyOne<br>Internal Implant System | AnyOne<br>Internal Fixture | K123988 | Internal<br>Hex | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, 6.8, 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,<br>4.8, 5.0, 5.5 |

The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.

| 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 System | Xpeed AnyRidge<br>Internal Fixture | K123870<br>K140091 | Internal<br>Hex | 4.0, 4.4, 4.9, 5.4, 5.9,<br>6.4, 6.9, 7.4, 7.9, 8.4 |
| | AnyOne<br>Internal Implant System | AnyOne<br>Internal Fixture | K123988 | Internal<br>Hex | 3.9, 4.3, 4.8, 5.3, 5.8,<br>6.3, 6.8, 7.3, 7.8, 8.3 |

The Cover Screw is compatible with following MEGAGEN Implants cleared under:

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The Healing Abutment, Scan Healing Abutment Screw are consisted of the following devices.

| Device | Content | | |
|----------------|------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Abutment | <b>Healing<br/>Abutment</b> | Description | The Healing Abutment helps to form suitable emergence<br>profile during period of gingival healing.<br>There are five types of Healing Abutments, Incisor, Canine, Pre-molar, Molar and Special type. |
| | | Material | Ti-6Al-4V ELI of ASTM F136-13 |
| | | Dimension<br>(Diameter,<br>Total Length) | Diameter: Ø 4.0 ~ 10.0 mm<br>Total Length: 4.4 ~ 11.35 mm |
| | | Angulation | Straight |
| | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>BLUEDIAMOND IMPLANT System |
| | <b>Scan<br/>Healing<br/>Abutment<br/>Screw</b> | Description | The Scan Healing Abutment Screw is used for connecting<br>Healing Abutment to the endosseous implant. |
| | | Used with | Healing Abutment |
| | | Material | Ti-6Al-4V ELI of ASTM F136-13 |
| | | Dimension<br>(Diameter &<br>Total Length) | Ø1.95 x 7.8 ~ 12.8 mm<br>Ø2.0 x 6.9 ~ 10.9 mm<br>Ø2.1 x 8.0 ~ 13.0 mm |
| | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System<br>BLUEDIAMOND IMPLANT System |
| 2. Cover Screw | | Description | The Cover Screw is used for protecting the inner structure of a<br>fixture, and exposed fixture platform after fixture placement. It<br>is used for submerged type surgery. |
| | | Material | Ti-6Al-4V ELI of ASTM F136-13 |
| | | Dimension<br>(Diameter,<br>Total Length) | Ø6.0 x 7.2 ~ 8.3 mm |
| | | Angulation | Straight |
| | | Compatible<br>Implant System | Xpeed AnyRidge Internal Implant System<br>AnyOne Internal Implant System |

## 6. Indication for use

MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.

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## 7. Basis for Substantial Equivalence

The Healing Abutment and Scan Healing Abutment Screw are substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size range of the subject device slightly differ from the predicate device however it is very minor not 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.

| Healing Abutment | | | | | | |
|--------------------------------------------|---------------------------------------------|-------------------------------|----------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|
| | Subject Device | Primary Predicate<br>Device | Reference Device | | | |
| 510k | K210826 | K192436 | K110955 | K123988 | K182448 | K181138 |
| Device Name | Healing Abutment | Healing Abutment | Healing Abutment<br>for AnyRidge<br>Internal Implant<br>System | Healing Abutment<br>for AnyOne<br>Internal Implant<br>System | Healing Abutment<br>for AnyRidge Octa<br>1 Implant System | IS Encoded Healing<br>Abutment for IS-III<br>active System |
| Manufacturer | MegaGen Implant<br>Co., Ltd. | Dentium Co., Ltd. | MegaGen Implant<br>Co., Ltd. | MegaGen Implant<br>Co., Ltd. | MegaGen Implant<br>Co., Ltd. | Neobiotech Co.,<br>Ltd. |
| Design | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment | Image: Healing Abutment |
| Diameter<br>(Ø, mm) | 4.0 ~ 10.0 | 3.70 ~ 9.64 | 4.2 ~ 10.0 | 4.2 ~ 9.7 | 3.2 ~ 7.2 | 4.0 ~ 9.0 |
| Gingival<br>Height<br>(Cuff Height,<br>mm) | 2.0 ~ 7.0 | unknown | 3.5 ~ 9.5 | 2.3 ~ 8.8 | 2.5 ~ 9.5 | 2.3 ~ 7.3 |
| Total Length<br>(mm) | 4.4 ~ 11.35 | 6.15 ~ 14.66 | 8.4 ~ 14.4 | 8.7 ~ 15.2 | 8.6 ~ 15.6 | 2.5 ~ 7.5 |
| Use with<br>Screw | Use with Screw | N/A | N/A | N/A | N/A | Use with Screw |
| Male Screw x<br>Pitch<br>(mm) | M1.8x0.35P,<br>M2.0x0.40P,<br>M1.6x0.35P | unknown | M1.8x0.35P | M2.0x0.4P | M1.6x0.35P | unknown |
| Connection | Internal Hex | Internal | Internal Conical<br>connection | Internal Conical<br>connection | Internal Conical<br>connection | Internal Hex |
| Materials | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of<br>ASTM F136 |
| Surface<br>Treatment | Machined<br>(Abutment)<br>Anodizing (Screw) | Machined | Machined | Machined | Anodizing | Machined |
| Sterilization | Gamma<br>Sterilization | Gamma<br>Sterilization | Gamma Sterilization | Gamma<br>Sterilization | Gamma Sterilization | Gamma<br>Sterilization |
| Shelf Life | 5 years | unknown | 5 years | 5 years | 5 years | 5 years |

#### Healing Abutment

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| | Subject Device | Primary Predicate<br>Device | Reference Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| indication for<br>use | MegaGen<br>Prosthetics are<br>intended for use as<br>an aid in prosthetic<br>rehabilitation. | Dentium<br>Prosthetics are<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | The AnyRidge<br>Internal Implant<br>System is intended<br>to be surgically<br>placed in the<br>maxillary or<br>mandibular molar<br>areas for the<br>purpose providing<br>prosthetic support<br>for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous<br>individuals. It is used<br>to restore a<br>patient's chewing<br>function. Smaller<br>implants (less than<br>Ø6.0 mm) are<br>dedicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with<br>appropriate occlusal<br>loading. Larger<br>implants are<br>dedicated for the<br>molar region and<br>are indicated for<br>delayed loading.<br><br>The AnyOne™<br>Internal Implant<br>System is<br>intended to be<br>surgically placed<br>in the maxillary or<br>mandibular molar<br>areas for the<br>purpose providing<br>prosthetic<br>support for dental<br>restorations<br>(Crown, bridges,<br>and overdentures)<br>in partially or fully<br>edentulous<br>individuals. It is<br>used to restore a<br>patient's chewing<br>function. Smaller<br>implants (less<br>than Ø6.0 mm)<br>are dedicated for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and with<br>appropriate<br>occlusal loading.<br>Larger implants<br>are dedicated for<br>the molar region<br>and are indicated<br>for delayed<br>loading.<br><br>The AnyRidge Octa 1<br>Implant System is<br>intended to be<br>surgically placed in<br>the maxillary or<br>mandibular arches<br>forthe purpose of<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous<br>individuals. It is<br>used to restore a<br>patient's chewing<br>function in the<br>following situations<br>and with the clinical<br>protocols:<br>- Delayed loading.<br>- Immediate loading<br>when good primary<br>stability is achieved<br>and with<br>appropriate occlusal<br>loading. Larger<br>implants are<br>dedicated for the<br>molar region.<br><br>The IS-III active<br>System is<br>indicated for use<br>in partially or fully<br>edentulous<br>mandibles and<br>maxillae, in<br>support of single<br>or multiple-unit<br>restorations<br>including;<br>cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate<br>Abutment support<br>for fixed<br>bridgework.<br>IS-III active<br>System is<br>dedicated for two<br>stage surgical<br>procedures and<br>for immediate<br>loading when<br>there is good<br>primary stability<br>and an<br>appropriate<br>occlusal load.<br>Also, implants<br>with diameters<br>larger than 5mm<br>are indicated for<br>molar regions. |
| Substantial Equivalence Discussion | | | |
| 1. Similarities<br>The subject device has the same characteristic for the followings compared to the primary predicate device and prior cleared reference devices.<br>- Design, Use with Screw, male Screw x Pitch, Connection, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use | | | |
| 2. Differences<br>The subject device has the different characteristic for the followings compared to the primary predicate device and prior cleared reference devices.<br>- Diameter, Gingival Height and Total Length<br>The Dimensions of subject device are slightly different with predicate and reference devices, but they are lie within the range of predicate device. But it does not cause a matter in substantial equivalence since these size differences are very minor, and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. | | | |
| 3. Discussion<br>Some of Healing Abutments had been FDA cleared with K110955, K123988 and K182448 but this submission is being submitted to add new dimensions with five different types to the patient's oral environment in the compatible implant system. Therefore, the proposed Healing Abutment and all prior cleared devices have common in Indication for Design, Diameter, Total Length, Use with Screw, Male Screw x Pitch, Connection, Material, Surface Treatment, Sterilization, Shelf Life and Indication for use. The differences are explained not affecting on the substantial equivalence.<br>Also, the fatigue testing is not considered since they help to form suitable emergence profile during period of gingival healing and are not placed into occlusion. | | | |

4. On the basis of the discussion above, it is concluded that the substantially equivalent to the predicate devices.

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The Cover Screw is substantially equivalent to the predicate device in terms of indication for use, technical characteristic and function. They are made of the same material and have similar design. The size of the subject device slightly differ from the predicate device however it is very minor not affecting substantial equivalence.

Based on the comparison charts below provided in this submission, we conclude that the subject device is substantially equivalent to the predicate device.

| | Subject Device | Primary Predicate<br>Device | Reference Device | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K210826 | K192436 | K110955 | K123988 | K150537 |
| Device Name | Cover Screw | Cover Screw | Cover Screw for<br>AnyRidge Internal<br>Implant System | Cover Screw for<br>AnyOne Internal<br>Implant System | Cover Screw for MiNi<br>Internal Implant System |
| Manufacturer | MegaGen Implant<br>Co., Ltd. | Dentium Co., Ltd. | MegaGen Implant Co.,<br>Ltd. | MegaGen Implant<br>Co., Ltd. | MegaGen Implant Co.,<br>Ltd. |
| Design | Image: Screw | Image: Screw | Image: Screw | Image: Screw | Image: Screw |
| Diameter<br>(Ø, mm) | 6.0 | 3.10 ~ 4.30 | 3.5 | 3.5 ~ 4.1 | 2.6, 3.5 |
| Total Length<br>(mm) | 7.2 ~ 8.3 | 4.70 ~ 8.92 | 5.7 ~ 7.5 | 6.75 ~ 8.75 | 3.1 ~ 10.25 |
| Male Screw x<br>Pitch<br>(mm) | M1.8x0.35P,<br>M2.0x0.40P | unknown | M1.8x0.35P | M2.0x0.40P | M1.4x0.30P,<br>M1.6x0.35P,<br>M1.8x0.35P,<br>M2.0x0.40P |
| Materials | Ti-6Al-4V ELI of<br>ASTM F136 | Ti-6Al-4V ELI of ASTM<br>F136 | Ti-6Al-4V ELI of ASTM<br>F136 | Ti-6Al-4V ELI of ASTM<br>F136…