Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is a dental implant intended to restore a patient's chewing function and provide prosthetic support, which are therapeutic actions.

Diagnostic

No

The device is a dental implant intended for prosthetic support and restoration of chewing function, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant made of CP Ti Grade 4, which is a physical hardware component. The intended use also describes surgical placement of this physical implant.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The description clearly states that this device is a dental implant intended to be surgically placed in the mouth to support dental restorations and restore chewing function. It is a physical implant placed within the body, not a device used to test samples outside the body.
Lack of IVD Characteristics: The information provided does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to disease or condition identification through in vitro methods.

Therefore, this device falls under the category of a surgically implanted medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the 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 Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

Delaved loading

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

The Bone Chamber Implant is consisted of the following.

The Bone Chamber Implant is compatible with following MEGAGEN abutments cleared under:
Bone Chamber Implant Fixture - Abutment Connection Diameter (mm): 2.8, 3.3, Prosthesis: EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, CCM Abutment, Octa Abutment, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, Meg-Ball Abutment, Meg-Loc Abutment, Meg-Magnet Abutment.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular arches, maxillary or mandibular molar areas.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Bone Chamber Implant since Bone Chamber Implant has same material composition, manufacturing process and patient contacting parts as the previously cleared device, AnyRidge Octa 1 Implant System (K182448) and XPEED AnyRidge Internal System (K122231).

Modified Surface Treatment: 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'. Bone Chamber Implant has same surface treatment and manufacturing process as the previously cleared device, XPEED AnyRidge Internal System (K122231) for the surface treatment of S.L.A.

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: Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10^-6). 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.

Performance (Physical Properties) Test: The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.

Fatigue test

MR Compatibility: Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

No clinical studies are submitted.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K182448, K063216

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K122231, K202832

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

7/18/2023

MegaGen Implant Co., Ltd. Eun Park Assistant Research Engineer 45, Secheon-ro, 7-gil Daegu, Dasa-eup, Dalesong-gun 42921 Korea. South

Re: K223339

Trade/Device Name: Bone Chamber Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 9, 2023 Received: June 16, 2023

Dear Eun Park:

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.

Sherrill Lathrop Blitzer

for Andrew 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) K223339

Device Name Bone Chamber Implant

Indications for Use (Describe)

· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the 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 Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

Delaved loading

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for K223339

Date: July 12, 2023

Applicant / Submitter 1.

MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828

2. Submission Correspondent

Eun Mi Park 45, Secheon-ro, 7-gil, Dasa-eup, Dalseong-gun, Daegu, Republic of Korea Tel: +82-53-222-3859 Fax: +82-53-247-2254 Email: ra4@imegagen.com

3. Device

■ Trade Name:	Bone Chamber Implant
■ Common Name:	Implant, Endosseous, Root-Form
■ Classification Name:	Endosseous Dental Implant
■ Classification Product Code:	DZE
■ Classification regulation:	Class II, 21 CFR 872.3640

4. Predicate Device

■

Section I : Smaller Implant

Primary Predicate Device: K182448- AnyRidge Octa 1 Implant System Reference Device: K122231- XPEED AnyRidge Internal System K202832-Implacil Implant System

Section II : Larger Implant

Primary Predicate Device: K063216- Rescue Internal Implant System Reference Devices: K122231- XPEED AnyRidge Internal System K182448-AnyRidge Octa 1 Implant System K202832-Implacil Implant System

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5. Description

Bone Chamber Implant is a dental implant made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

Device	Content
1. Fixture
Products	Bone Chamber
Implant	Description	The Bone Chamber Implant is intended to be
surgically placed in the maxillary or mandibular
molar arches for smaller implants and in the
maxillary or mandibular molar areas for larger
implants. It purpose providing prosthetic support for
dental restorations (Crown, bridges, and
overdentures) in partially or fully edentulous
individuals.
		Material	CP Ti Grade 4 of ASTM F67
		Wide Thread
Dimension
(Diameter &
Total Length)	Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
Ø4.4 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
Ø5.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
Ø5.6 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
Ø6.5 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
Ø7.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm

The Bone Chamber Implant is consisted of the following.

The Bone Chamber Implant is compatible with following MEGAGEN abutments cleared under:

| Device | Fixture - Abutment
Connection
Diameter (mm) | Prosthesis | 510(k) Number |
|-------------------------|---------------------------------------------------|----------------------------|---------------|
| Bone Chamber
Implant | 2.8, 3.3 | EZ Post Abutment | K182448 |
| | | Angled Abutment | |
| | | Milling Abutment | |
| | | Octa Abutment | |
| | | Multi-unit Abutment | |
| | | Multi-unit Angled Abutment | |
| | | CCM Abutment | |
| | | Octa Abutment | |
| | | Healing Abutment | |
| | | Temporary Abutment | |
| | | Fuse Abutment | |
| | | Abutment Screw | |
| | | Meg-Ball Abutment | |
| | | Meg-Loc Abutment | |
| | | Meg-Magnet Abutment | |

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6. Indication for use

. Smaller Implant (Wide Thread Diameter: Ø 4.0 ~ Ø 5.0 mm) The smaller Implant is intended to be surgically placed in the maxillary or mandibular arches for the 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 Implant (Wide Thread Diameter: Ø 5.6 ~ Ø 7.0 mm) The larger Implant is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading.

7. Basis for Substantial Equivalence

The Bone Chamber Implant is substantially equivalent to the predicate devices in terms of indication for use, technical characteristic and function. They are material and have similar design. Performance test of subject device demonstrated the minor differences in technological characteristics do not affect substantial equivalence.

The Indications for Use for the subject devices is divided into two types. One is for smaller implant (Wide Thread Diameter: Ø 4.0 ~ Ø 5.0 mm), and the other is for larger implants (Wide Thread Diameter: Ø 5.6 ~ Ø 7.0 mm). The Indication for Use of smaller implants is identical to the primary predicate, K182448. The Indications for Use for the larger implants is similar to the primary predicate device, K063216. The subject device, compared to the predicate, includes specific information on when the device should be loaded. This aspect does not affect substantial equivalence as the Indications for the subject device fall within the Indications of the predicate device

In order to demonstrate the difference in design does not raise any new issues, the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. The test result supports the substantial equivalence to the predicate devices.

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 devices.

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Bone Chamber Implant

Table 1. Comparison on AnyRidge Octa 1 Implant System (K182448)

	Subject Device	Primary Predicate Device	Reference Device
510(k) No.	K223339	K182448	K122231	K202832
Device Name	Bone Chamber Implant	AnyRidge Octa 1 Implant
System	XPEED AnyRidge Internal
Implant System	Implacil Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	Implacil De Bortoli Material
Odontologico Ltda
Indications for Use
Statement	The smaller Implant is intended
to be surgically placed in the
maxillary or mandibular arches
for the 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.	The AnyRidge Octa 1 Implant
System is intended to be
surgically placed in the
maxillary or mandibular arches
for the 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 XPEED AnyRidge Internal
Implant System is intended to
be surgically placed in the
maxillary or mandibular molar
areas for the purpose providing
prosthetic support for dental
restorations (Crown, bridges,
and overdentures) in partially
or fully edentulous individuals.
It is used to restore patients
chewing function. Smaller
implants (less than 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	Implacil Implant System is
intended for placement in the
maxillary or mandibular arch to
provide support for single-unit
and/or multi-unit restorations.
When a one-stage surgical
approach is applied, the
Implacil Implant System is
intended for
immediate loading when good
primary stability is achieved
and with appropriate occlusal
loading.
Design
Widest Thread
Diameter (Ø, mm) &
Total Length(mm)	· Normal thread
$Ø$ 4.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
$Ø$ 4.4 X 7.7, 9.2, 10.7, 12.2, 14.2 mm
$Ø$ 5.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mm	· Normal thread
$Ø$ 3.6 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 4.7 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
· Deep thread
$Ø$ 4.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 4.4 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 4.8 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 5.0 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm
$Ø$ 5.5 X 7.0, 7.7, 9.2, 10.7, 12.2, 14.2,
17.2 mm	· Normal thread
$Ø$ 4.0 X 7.7, 9.2, 10.7, 12.2, 14.2,
17.2
$Ø$ 4.4 X 7.7, 9.2, 10.7, 12.2, 14.2,
17.2
$Ø$ 4.9 X 7.7, 9.2, 10.7, 12.2, 14.2,
17.2
$Ø$ 5.4 X 7.7, 9.2, 10.7, 12.2, 14.2,
17.2
$Ø$ 5.9 X 7.7, 9.2, 10.7, 12.2, 14.2,
17.2
· Deep thread
$Ø$ 6.4 X 7.9, 9.4, 10.9, 12.4, 14.4
$Ø$ 6.9 X 7.9, 9.4, 10.9, 12.4, 14.4
$Ø$ 7.4 X 7.9, 9.4, 10.9, 12.4, 14.4
$Ø$ 7.9 X 7.9, 9.4, 10.9, 12.4, 14.4
$Ø$ 8.4 X 7.9, 9.4, 10.9, 12.4, 14.4	$Ø$ 3.5 X 8.0, 9.0, 10.0, 11.0, 12.0,
13.0, 14.0, 15.0 mm
$Ø$ 4.0 X.7.0, 8.0, 9.0, 10.0, 11.0,
12.0, 13.0, 14.0, 15.0 mm
$Ø$ 5.0 X 7.0, 8.0, 9.0, 10.0, 11.0, 12.0,
13.0, 14.0, 15.0 mm
Implant-to Abutment
Connection	Internal Octa	Internal Octa	Internal Hex	Internal Hex
External Hex
Material	CP Ti Grade 4 (ASTM F67)	CP Ti Grade 4 (ASTM F67)	CP Ti Grade 4 (ASTM F67)	CP Ti Grade 4 (ASTM F67)
Single Use	Yes	Yes	Yes	Yes
Surface Treatment	Sand-blasted, Large grit, Acid-
etched (SLA)	Sand-blasted, Large grit, Acid-
etched (SLA)	Sand-blasted, Large grit, Acid-
etched (SLA)	Sand-blasted, Large grit, Acid- etched (SLA)
Sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization	Gamma sterilization
Shelf Life	5 years	5 years	5 years	5 years
Feature	- Straight / Tapered body shape

Submerged implant | - Straight / Tapered body shape
Submerged implant
cutting edge with self-tapping | - Submerged implant
Tapered body
cutting edge with self-tapping | - Tapered body
cutting edge with self-tapping |
| Chamber | - Yes | No | No | - Yes |

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	- Angle : 40~60°						- Angle : 55°
		- Shape : Hemispherical shape						- Shape : Radial channel
Principle of Operation		It is a tapered body fixture
which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.		It is a tapered body fixture
which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.		It is a tapered body fixture
which is inserted in the
alveolar bone. It replaces the
functions of the missing teeth
as a dental implant fixture.
Substantial Equivalence Discussion
Similarities				The subject device has the similar characteristic for the followings compared to the predicate device.
				Indication for use, Design, Connection, Material, Single Use, Surface Treatment, Sterilization, Shelf Life and Principle of Operation.
Differences
				The subject device has the different characteristic for the followings compared to the predicate device.
	Design presence of chambers
				The presence of chambers of subject device is different with predicate device, but the reference has it, but with different technical
				characteristics. These differences are explained not affecting on the substantial equivalence.
		Subject Device			Predicate
	Model name	Widest Thread
Diameter
(Ø,mm)	Total Length
(mm)	Model name	Widest Thread
Diameter
(Ø,mm)	Total Length
(mm)	510k
	BC3308	4.0	7.7	ARO3708	4.0	7.7	K182448
	BC3310	4.0	9.2	ARO3710	4.0	9.2	K182448
	BC3311	4.0	10.7	ARO3711	4.0	10.7	K182448
	BC3313	4.0	12.2	ARO3713	4.0	12.2	K182448
	BC3315	4.0	14.2	ARO3715	4.0	14.2	K182448
	BC3808	4.4	7.7	ARO4108	4.4	7.7	K182448
	BC3810	4.4	9.2	ARO4110	4.4	9.2	K182448
	BC3811	4.4	10.7	ARO4111	4.4	10.7	K182448
	BC3813	4.4	12.2	ARO4113	4.4	12.2	K182448
	BC3815	4.4	14.2	ARO4115	4.4	14.2	K182448
	BC4308	5.0	7.7	ARO4808	5.0	7.7	K182448
	BC4310	5.0	9.2	ARO4810	5.0	9.2	K182448
	BC4311	5.0	10.7	ARO4811	5.0	10.7	K182448
	BC4313	5.0	12.2	ARO4813	5.0	12.2	K182448
	BC4315	5.0	14.2	ARO4815	5.0	14.2	K182448

Feature : Cutting edge

Cutting edge is for self-tapping, which does not affect the physical or performance.

- Discussion

The proposed Bone Chamber Implant have common in the comparison chart except the design presence of chambers and cutting edge. These differences are explained not affecting on the substantial equivalence. The fatigue test was performed on worst asse to confirm the substantial equivalence acording to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment".

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

8

| | Subject Device | Primary Predicate Device | Reference Device | | | | Surface
Treatment | | | | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| 510(k) No. | K223339 | K063216 | K122231 | K182448 | K202832 | | Sand-blasted, Large grit,
Acid-etched (SLA) | Sand-blasted, Acid-
etched (RBM) | Sand-blasted, Large grit,
Acid-etched (SLA) | Sand-blasted, Large grit,
Acid-etched (SLA) | |
| Device Name
(Compatible
Implant System) | Bone Chamber Implant | Rescue Internal Implant
System | XPEED AnyRidge Internal
Implant System | AnyRidge Octa 1 Implant
System | Implacil Implant System | Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | |
| Manufacturer | MegaGen Implant Co.,
Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Implacil De Bortoli
Material Odontologico
Ltda | Shelf Life | 5 years | 5 years | 5 years | 5 years | |
| Indications for
Use Statement | The larger Implant is
intended to be surgically
placed in the maxillary or
mandibular molar areas
for the purpose of
providing prosthetic
support for dental
restorations (Crown,
bridges, and overdentures)
in partially or fully
edentulous individuals.
These implants can be
used where smaller
implants have failed.
It is used to restore a
patient's chewing function
in the following situations
and with the clinical
protocols:
-Delayed loading. | Rescue Internal Implant
System is intended to be
surgically placed in the
maxillary or mandibular
molar areas for the
purpose of providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. These implants
can be used where smaller
implants have failed. | The XPEED AnyRidge
Internal Implant System is
intended to be surgically
placed in the maxillary or
mandibular molar areas
for the purpose providing
prosthetic support for
dental restorations
(Crown, bridges, and
overdentures) in partially
or fully edentulous
individuals. It is used to
restore patients chewing
function. Smaller implants
(less than 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 AnyRidge Octa 1
Implant System is intended
to be surgically placed in
the maxillary or
mandibular arches for the
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. | Implacil Implant System is
intended for placement in
the maxillary or
mandibular arch to
provide support for single-
unit and/or multi-unit
restorations. When a one-
stage surgical approach is
applied, the Implacil
Implant System is intended
for immediate loading
when good primary
stability is achieved and
with appropriate occlusal
loading. | Feature | - Straight / Tapered body
shape

Submerged implant | - Submerged implant
Mose Tapered body
cutting edge with self-
tapping | - Submerged implant
Tapered body
cutting edge with self-
tapping | - Straight / Tapered body
shape
Submerged implant
cutting edge with self-
tapping | |
| Design | Image: Bone Chamber Implant | Image: Rescue Internal Implant System | Image: XPEED AnyRidge Internal Implant System | Image: AnyRidge Octa 1 Implant System | Image: Implacil Implant System | Design - presence
of chambers | Yes | No | No | No | Yes |
| Widest Thread
Diameter (Ø,
mm) & Total
Length(mm) | • Deep thread
Ø5.6 X 7.7, 9.2, 10.7, 12.2,
14.2 mm
Ø6.5 X 7.7, 9.2, 10.7, 12.2,
14.2 mm
Ø7.0 X 7.7, 9.2, 10.7, 12.2,
14.2 mm | Ø6.0 X 7.0, 8.0, 9.5, 11.0, 12.5
mm
Ø6.5 X 7.0, 8.0, 9.5, 11.0, 12.5
mm
Ø7.0 X 7.0, 8.0, 9.5, 11.0, 12.5
mm
Ø8.0 X 7.0, 8.0, 9.5, 11.0,
12.5 mm | • Normal thread
Ø4.0 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.4 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.9 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø5.4 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø5.9 X 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
• Deep thread
Ø6.4 X 7.9, 9.4, 10.9, 12.4,
14.4 mm
Ø6.9 X 7.9, 9.4, 10.9, 12.4,
14.4 mm
Ø7.4 X 7.9, 9.4, 10.9, 12.4,
14.4 mm
Ø7.9 X 7.9, 9.4, 10.9, 12.4,
14.4 mm
Ø8.4 X 7.9, 9.4, 10.9, 12.4,
14.4 mm | • Normal thread
Ø3.6 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.7 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
• Deep thread
Ø4.0 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.4 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø4.8 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø5.0 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm
Ø5.5 X 7.0, 7.7, 9.2, 10.7, 12.2,
14.2, 17.2 mm | Ø3.5 X 8.0, 9.0, 10.0, 11.0,
12.0, 13.0, 14.0, 15.0 mm
Ø4.0 X 7.0, 8.0, 9.0, 10.0, 11.0,
12.0, 13.0, 14.0, 15.0 mm
Ø5.0 X 7.0, 8.0, 9.0, 10.0, 11.0,
12.0, 13.0, 14.0, 15.0 mm | Principle of
Operation | It is a tapered body fixture
which is inserted in the
alveolar bone. It replaces
the functions of the
missing teeth as a dental
implant fixture. | This product is dental
implant which is inserted
in the alveolar bone. It
replaces the functions of
the missing teeth as a
dental implant fixture. | This product is dental
implant which is inserted
in the alveolar bone. It
replaces the functions of
the missing teeth as a
dental implant fixture. | It is a tapered body fixture
which is inserted in the
alveolar bone. It replaces
the functions of the
missing teeth as a dental
implant fixture. | - |
| Implant-to
Abutment
Connection | Internal Octa | Internal Hex | Internal Hex | Internal Octa | Internal Hex
External Hex | Substantial Equivalence Discussion | | | | | |
| Material | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | CP Ti Grade 4 (ASTM F67) | | | | | | |

Table 2. Comparison on Rescue Internal Implant System (K063216)

9

Similarities -

The subject device has the same characteristic for the followings compared to the predicate device.

Indication for use, Design, Material, Single Use, Sterilization, Shelf Life, Principle of Operation.

Differences

The subject device has the different characteristic for the followings compared to the predicate device.

Connection -
- The connection of subject device is different with predicate device but has same connection with reference.
-Surface Treatment
- The Surface treatment of subject device is different with predicate device but has same surface treatment with reference. Design presence of chambers
- The presence of chambers of subject device, with predicate device, but the reference has it, but with different technical characteristics. These differences are explained not affecting on the substantial equivalence.
-Feature
Cutting edge is for self-tapping, which does not affect the physical or performance.
Widest Thread Diameter & Total Length -

The Widest Thread Diameter and Total Lence are slightly different with predicate device but all the dimensions of subject device ie within the range of predicate device. But the majority of the Widest Thread diameter and Total length combinations of the subject device is not same to the predicate and reference is to provide a variety of implant dimensions because the deep thread size of the alveolar bone hole varies when a small implant fails. It does not cause a matter in substantial equivalence.

Subject Device			Predicate/ Reference				Difference
Model name	Widest
Thread
Diameter
(Ø,mm)	Total Length
(mm)	Model name	Widest
Thread
Diameter
(Ø,mm)	Total Length
(mm)	510k	Widest Thread
Diameter / Length	Dimension
(mm)
BC4808	5.6	7.7	ARO4808D	5.5	7.7	K182448	Larger diameter	0.1
BC4810	5.6	9.2	ARO4810D	5.5	9.2	K182448	Larger diameter	0.1
BC4811	5.6	10.7	ARO4811D	5.5	10.7	K182448	Larger diameter	0.1
BC4813	5.6	12.2	ARO4813D	5.5	12.2	K182448	Larger diameter	0.1
BC4815	5.6	14.2	ARO4815D	5.5	14.2	K182448	Larger diameter	0.1
BC5308	6.5	7.7	RSWIR6508	6.5	8	K063216	Shorter length	0.3
BC5310	6.5	9.2	RSWIR6510	6.5	9.5	K063216	Shorter length	0.3
BC5311	6.5	10.7	RSWIR6511	6.5	11	K063216	Shorter length	0.3
BC5313	6.5	12.2	RSWIR6513	6.5	12.5	K063216	Shorter length	0.3
BC5315	6.5	14.2	FALIHX6015	6.9	14.4	K122231	Smaller diameter
Shorter length	0.4
0.2
BC5808	7	7.7	RSWIR7008	7	8	K063216	Shorter length	0.3
BC5810	7	9.2	RSWIR7010	7	9.5	K063216	Shorter length	0.3
BC5811	7	10.7	RSWIR7011	7	11	K063216	Shorter length	0.3
BC5813	7	12.2	RSWIR7013	7	12.5	K063216	Shorter length	0.3
BC5815	7	14.2	FALIHX7015	7.4	14.4	K122231	Smaller diameter
Shorter length	0.4
0.2

Discussion

The proposed Bone Chamber Inplant have common in all the terms in the comection, surface treatment, design presence of chambers, Cutting edge, Widest Thread Diameter and Total These are explained not affecting on the substantial equivalence. The fairgue test was performed on worst case to confirm the substantial en "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment".

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

10

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 Bone Chamber Implant since Bone Chamber Implant has same material composition, manufacturing process and patient contacting parts as the previously cleared device, AnyRidge Octa 1 Implant System (K182448) and XPEED AnyRidge Internal System (K122231).

Modified Surface Treatment

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'.

Bone Chamber Implant has same surface treatment and manufacturing process as the previously cleared device, XPEED AnyRidge Internal System (K122231) for the surface treatment of S.L.A.

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

Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 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.
I Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

Performance (Physical Properties) Test

The following bench tests have been performed in accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of the subject devices and the test results met the pre-set criteria.

. Fatigue test

MR Compatibility

Non-clinical worst-case MRI review was performed to evaluate the metallic MegaGen Dental Implant system as MR Conditional in the MRI environment using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.

11

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 Bone Chamber Implant is substantially equivalent to the predicate device as herein.