Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and intended use of dental prosthetics, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is described as an aid in prosthetic rehabilitation and soft tissue contouring, but its function does not directly treat or cure a disease or medical condition.

Diagnostic

No

Explanation: The device description states its purpose is to "aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed." This function is therapeutic and reconstructive, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components (Healing Abutment, Scan Healing Abutment Screw, Cover Screw) made of materials and sterilized, indicating a hardware medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "as an aid in prosthetic rehabilitation." This describes a device used in a surgical and restorative procedure within the body, not for testing samples taken from the body.
Device Description: The description details physical components (Healing Abutment, Scan Healing Abutment Screw, Cover Screw) used to interact with an implant and soft tissue within the mouth. This is consistent with a medical device used in a clinical setting, not a diagnostic test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and related to supporting dental prosthetics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

NHA

Device 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.

The Healing Abutment and Scan Healing Abutment screw are compatible with following MEGAGEN Implants cleared under:

Xpeed AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System

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.

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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)

Summary of Non-Clinical Testing

Biocompatibility: Evaluation performed in accordance with International Standard ISO 10993-1. No additional testing required for the Healing Abutment and Cover Screw as they have the same material composition, manufacturing process, and patient-contacting parts as prior cleared devices (K110955, K123988, K182448, K150537).
Modified Surface Treatment:
- Healing Abutment: Non surface-treated, similar to predicate devices (K181138, K110955, K123988, K182448).
- Scan Healing Abutment Screw: Surface treatment evaluation performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. Has same surface treatment (Anodizing) and manufacturing process as prior cleared device K182448. Anodizing for Scan Healing abutment Screw is to distinguish sizes with the naked eyes for convenience and does not affect fundamental functions, safety, or effectiveness.
Pyrogen and Endotoxin Test: Device will not be labeled as "non-pyrogenic". Endotoxin testing conducted on every batch with a testing limit below 0.5 EU/mL in accordance with USP 39 .
Sterilization validation and Shelf Life:
- Sterilization validation testing performed in accordance with ISO 11137 to verify a sterility assurance level (10⁻⁶).
- Shelf life validated for 5 years using the accelerated aging method in accordance with ASTM F1980.
Performance test:
- Precision Fit Test: Performed. Worst-case scenario consideration for sample selection was not necessary due to consistent connection dimensions (D1) among Healing Abutment and Implant of each implant system. Tests conducted by randomly selecting from subject devices in each Implant System.
- Fatigue testing is not considered since they help to form suitable emergence profile during period of gingival healing and are not placed into occlusion.

Summary of Clinical Testing

No clinical studies are submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K192436

Reference Device(s)

K110955, K123988, K182448, K181138, K150537

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.)

Summary

0

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.

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 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

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

3

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: +82-53-247-2262 Fax: +82-53-247-2254 Email: ra7@dgri.co.kr

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

4

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
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|-------------------------------------------|------------------------------------|--------------------|------------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | Xpeed AnyRidge
Internal Implant System | Xpeed AnyRidge
Internal Fixture | K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9,
6.4, 6.9, 7.4, 7.9, 8.4 |
| | AnyOne
Internal Implant System | AnyOne
Internal Fixture | K123988 | Internal
Hex | 3.9, 4.3, 4.8, 5.3, 5.8,
6.3, 6.8, 7.3, 7.8, 8.3 |
| | BLUEDIAMOND
IMPLANT System | BLUEDIAMOND
IMPLANT | K182448 | Internal
Octa | 3.6, 3.7, 4.0, 4.1, 4.4,
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
System | Device Name | 510(k)
Number | Connection | Diameter (mm) |
|---------------------------------|-------------------------------------------|------------------------------------|--------------------|-----------------|-----------------------------------------------------|
| MegaGen
Implant Co.,
Ltd. | Xpeed AnyRidge
Internal Implant System | Xpeed AnyRidge
Internal Fixture | K123870
K140091 | Internal
Hex | 4.0, 4.4, 4.9, 5.4, 5.9,
6.4, 6.9, 7.4, 7.9, 8.4 |
| | AnyOne
Internal Implant System | AnyOne
Internal Fixture | K123988 | Internal
Hex | 3.9, 4.3, 4.8, 5.3, 5.8,
6.3, 6.8, 7.3, 7.8, 8.3 |

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

5

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

Device	Content
1. Abutment	Healing
Abutment	Description	The Healing Abutment helps to form suitable emergence
profile during period of gingival healing.
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
(Diameter,
Total Length)	Diameter: Ø 4.0 ~ 10.0 mm
Total Length: 4.4 ~ 11.35 mm
		Angulation	Straight
		Compatible
Implant System	Xpeed AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
	Scan
Healing
Abutment
Screw	Description	The Scan Healing Abutment Screw is used for connecting
Healing Abutment to the endosseous implant.
		Used with	Healing Abutment
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension
(Diameter &
Total Length)	Ø1.95 x 7.8 ~ 12.8 mm
Ø2.0 x 6.9 ~ 10.9 mm
Ø2.1 x 8.0 ~ 13.0 mm
		Compatible
Implant System	Xpeed AnyRidge Internal Implant System
AnyOne Internal Implant System
BLUEDIAMOND IMPLANT System
2. Cover Screw		Description	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.
		Material	Ti-6Al-4V ELI of ASTM F136-13
		Dimension
(Diameter,
Total Length)	Ø6.0 x 7.2 ~ 8.3 mm
		Angulation	Straight
		Compatible
Implant System	Xpeed AnyRidge Internal Implant System
AnyOne Internal Implant System

6. Indication for use

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

6

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
Device	Reference Device
510k	K210826	K192436	K110955	K123988	K182448	K181138
Device Name	Healing Abutment	Healing Abutment	Healing Abutment
for AnyRidge
Internal Implant
System	Healing Abutment
for AnyOne
Internal Implant
System	Healing Abutment
for AnyRidge Octa
1 Implant System	IS Encoded Healing
Abutment for IS-III
active System
Manufacturer	MegaGen Implant
Co., Ltd.	Dentium Co., Ltd.	MegaGen Implant
Co., Ltd.	MegaGen Implant
Co., Ltd.	MegaGen Implant
Co., Ltd.	Neobiotech Co.,
Ltd.
Design	Image: Healing Abutment	Image: Healing Abutment	Image: Healing Abutment	Image: Healing Abutment	Image: Healing Abutment	Image: Healing Abutment
Diameter
(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
Height
(Cuff Height,
mm)	2.0 ~ 7.0	unknown	3.5 ~ 9.5	2.3 ~ 8.8	2.5 ~ 9.5	2.3 ~ 7.3
Total Length
(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
Screw	Use with Screw	N/A	N/A	N/A	N/A	Use with Screw
Male Screw x
Pitch
(mm)	M1.8x0.35P,
M2.0x0.40P,
M1.6x0.35P	unknown	M1.8x0.35P	M2.0x0.4P	M1.6x0.35P	unknown
Connection	Internal Hex	Internal	Internal Conical
connection	Internal Conical
connection	Internal Conical
connection	Internal Hex
Materials	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136	Ti-6Al-4V ELI of
ASTM F136
Surface
Treatment	Machined
(Abutment)
Anodizing (Screw)	Machined	Machined	Machined	Anodizing	Machined
Sterilization	Gamma
Sterilization	Gamma
Sterilization	Gamma Sterilization	Gamma
Sterilization	Gamma Sterilization	Gamma
Sterilization
Shelf Life	5 years	unknown	5 years	5 years	5 years	5 years

Healing Abutment

7

| | Subject Device | Primary Predicate
Device | Reference Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| indication for
use | MegaGen
Prosthetics are
intended for use as
an aid in prosthetic
rehabilitation. | Dentium
Prosthetics are
intended for use
as an aid in
prosthetic
rehabilitation. | The 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.

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.

The AnyRidge Octa 1
Implant System is
intended to be
surgically placed in
the maxillary or
mandibular arches
forthe purpose of
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 in the
following situations
and with the clinical
protocols:

Delayed loading.
Immediate loading
when good primary
stability is achieved
and with
appropriate occlusal
loading. Larger
implants are
dedicated for the
molar region.

The IS-III active
System is
indicated for use
in partially or fully
edentulous
mandibles and
maxillae, in
support of single
or multiple-unit
restorations
including;
cemented
retained, screw
retained, or
overdenture
restorations, and
terminal or
intermediate
Abutment support
for fixed
bridgework.
IS-III active
System is
dedicated for two
stage surgical
procedures and
for immediate
loading when
there is good
primary stability
and an
appropriate
occlusal load.
Also, implants
with diameters
larger than 5mm
are indicated for
molar regions. |
| Substantial Equivalence Discussion | | | |
| 1. Similarities
The subject device has the same characteristic for the followings compared to the primary predicate device and prior cleared reference devices.

Design, Use with Screw, male Screw x Pitch, Connection, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use | | | |
| 2. Differences
The subject device has the different characteristic for the followings compared to the primary predicate device and prior cleared reference devices.
Diameter, Gingival Height and Total Length
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
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.
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. | | | |

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

8

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
Device | Reference Device | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | K210826 | K192436 | K110955 | K123988 | K150537 |
| Device Name | Cover Screw | Cover Screw | Cover Screw for
AnyRidge Internal
Implant System | Cover Screw for
AnyOne Internal
Implant System | Cover Screw for MiNi
Internal Implant System |
| Manufacturer | MegaGen Implant
Co., Ltd. | Dentium Co., Ltd. | MegaGen Implant Co.,
Ltd. | MegaGen Implant
Co., Ltd. | MegaGen Implant Co.,
Ltd. |
| Design | Image: Screw | Image: Screw | Image: Screw | Image: Screw | Image: Screw |
| Diameter
(Ø, mm) | 6.0 | 3.10 ~ 4.30 | 3.5 | 3.5 ~ 4.1 | 2.6, 3.5 |
| Total Length
(mm) | 7.2 ~ 8.3 | 4.70 ~ 8.92 | 5.7 ~ 7.5 | 6.75 ~ 8.75 | 3.1 ~ 10.25 |
| Male Screw x
Pitch
(mm) | M1.8x0.35P,
M2.0x0.40P | unknown | M1.8x0.35P | M2.0x0.40P | M1.4x0.30P,
M1.6x0.35P,
M1.8x0.35P,
M2.0x0.40P |
| Materials | Ti-6Al-4V ELI of
ASTM F136 | Ti-6Al-4V ELI of ASTM
F136 | Ti-6Al-4V ELI of ASTM
F136 | Ti-6Al-4V ELI of ASTM
F136 | Ti-6Al-4V ELI of ASTM
F136 |
| Surface
Treatment | Machined | TiN Coated | Anodizing | Anodizing | Anodizing, Machined |
| Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 5 years | unknown | 5 years | 5 years | 5 years |
| | Subject Device | Primary Predicate Device | Reference Device | | |
| indication for
use | MegaGen
Prosthetics are
intended for use as
an aid in prosthetic
rehabilitation. | Dentium Prosthetics
are intended for use
as an aid in prosthetic
rehabilitation. | The 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
$Ø$ 6.0 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. | 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
$Ø$ 6.0 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. | 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. |
| Substantial Equivalence Discussion | | | | | |
| 1. | Similarities
The subject device has the same characteristic for the followings compared to the primary predicate devices.
Design, Male Screw x Pitch, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use | | | | |
| 2. | Differences
The subject device has the different characteristic for the followings compared to the primary predicate devices.
Diameter
The Diameter of subject device is slightly different with predicate and reference devices. But it does not cause a matter in substantial
equivalence since the difference is very minor, and the variety of the size can be possible to operate more precise treatment to meet
each patient's condition.
Total Length
The Total Length 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
The proposed Cover Screw had been FDA cleared under K110955, K123988 and K150537 but this submission is being submitted to add
new dimensions in the compatible implant system. Therefore, the proposed Cover Screw and prior cleared devices have common in
Indication for Design, Dimensions, Male Screw x Pitch, Materials, Surface Treatment, Sterilization, Shelf Life and Indication for use.
The differences are explained not affecting on the substantial equivalence. | | | | |
| 4. | On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device. | | | | |

Cover Screw

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1. On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.

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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.

Biocompatibility

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".

The additional biocompatibility testing is not required on the Healing Abutment and Cover Screw since these have same material composition, manufacturing process and patient contacting parts as the prior cleared Healing Abutment and Cover Screw for AnyRidge Internal Implant System(K110955), AnyOne Internal Implant System(K123988), AnyRidge Octa 1 Implant System(K182448) and MiNi Internal Implant System(K150537).

Modified Surface Treatment

The Healing Abutment is non surface-treated as predicate devices, IS Encoded Healing Abutment(K181138) and Healing Abutment for AnyRidge Internal Implant System(K110955), AnyOne Internal Implant System(K123988) and AnyRidge Octa 1 Implant System(K182448).

For Scan Healing Abutment Screw, the surface treatment evaluation has been performed in accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.

The Scan Healing Abutment Screw has same surface treatment and manufacturing process as prior cleared device, AnyRidge Octa 1 Implant System (K182448) for Anodizing. The purpose of Anodizing for Scan Healing abutment Screw is to distinguish the sizes with the naked eyes for convenience. And It doesn't affect device's fundamental functions, safety and effectiveness.

Pyrogen and Endotoxin Test

The subject device 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 .

Sterilization validation and Shelf Life

Sterilization validating testing has been performed in accordance with ISO 11137 to verify the sterility assurance level (10 %). 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.

Also, the following guidance documents were referred to:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

Performance test

The five types of Healing Abutment in each Implant System have similar design and same indication for use, principle of operation, technical characteristics and function. And since the connection dimensions of D1, the Healing Abutment and Implant of each implant system, are all the same, so it was not necessary to consider the worst-case scenario when selecting a sample for the performance test of the subject device such as the precision fit test. Therefore, the test was conducted by selecting randomly among the subject devices in each Implant System.

▪ Precision Fit Test

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9. Summary of Clinical Testing

No clinical studies are submitted.

10. Conclusion

Based on the information provided in this premarket notification, We, MegaGen Implant Co., Ltd. conclude that the Healing Abutment and Cover Screw is substantially equivalent to the predicate device as herein.