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

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.

AI/ML Overview

This appears to be a 510(k) summary for a dental implant, "Bone Chamber Implant," seeking substantial equivalence to existing predicate devices. Consequently, the document describes non-clinical bench testing to demonstrate equivalence, rather than clinical trials with human subjects. Therefore, many of the requested items related to clinical study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) will not be applicable and the acceptance criteria will be based on engineering performance standards.

Here's an analysis based on the provided text:

Key Takeaway: The device's acceptance criteria and proven performance are primarily based on demonstrating mechanical equivalence to predicate devices through bench testing, specifically fatigue testing, following ISO and FDA guidance. No clinical studies were performed.

Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are the ability of the device to meet the specified performance standards in the referenced guidance documents and ISO standards, and to perform comparably to the predicate devices. The "reported device performance" is that the device met these criteria.

Acceptance Criteria (Referenced Standards/Guidance)	Reported Device Performance (Summary)
Biocompatibility: In accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."	Deemed compliant as it has the same material composition, manufacturing process, and patient-contacting parts as previously cleared devices (K182448, K122231). No additional biocompatibility testing required.
Modified Surface Treatment: In accordance with 'Section 11 of Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'.	Deemed compliant as it has the same surface treatment and manufacturing process (S.L.A.) as a previously cleared device (K122231).
Pyrogen and Endotoxin Test: Testing limit below 0.5 EU/mL in accordance with USP 39 <85>.	Endotoxin testing will be conducted on every batch. (Note: This is a promise for future batch testing, not a reported result from a study.)
Sterilization Validation: Sterility assurance level (10⁻⁶) in accordance with ISO 11137 and ISO 17665-1, 2. Shelf life of 5 years validated by accelerated aging (ASTM F1980).	Validated to meet sterility assurance level (10⁻⁶) and achieve a 5-year shelf life.
Performance (Physical Properties): In accordance with "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," specifically for fatigue test.	Fatigue tests were performed on "worst case" scenarios and the results "met the pre-set criteria," supporting substantial equivalence.
MR Compatibility: Evaluation for MR Conditional status based on scientific rationale and published literature (Woods et al., 2019) and FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." Includes magnetically induced displacement force and torque.	Non-clinical worst-case MRI review was performed, and rationale was addressed for parameters in the FDA guidance. Implied to be MR Conditional.

Study Details (Non-Clinical Bench Testing)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count for each test (e.g., number of implants tested for fatigue). The document states "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'." For regulatory submissions like 510(k), compliance with the standards' requirements for sample size is assumed.
- Data Provenance: The studies were non-clinical bench tests, not involving human data. The company is MegaGen Implant Co., Ltd., located in Daegu, South Korea. The testing was conducted internally or by a contracted lab to meet international and FDA standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was non-clinical bench testing of physical properties, not an assessment requiring expert clinical judgment or ground truth determination (like image interpretation). The "ground truth" here is the physical measurement against a standard.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to clinical adjudication, which is not relevant for bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. No MRMC study was done, as this is a physical dental implant, not an AI software or imaging device that human readers would interpret.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Specifications. The "ground truth" for non-clinical testing refers to the established requirements and thresholds defined by international standards (e.g., ISO 14801) and FDA guidance documents for medical device performance (e.g., fatigue strength, biocompatibility, sterilization efficacy). The device's performance is compared against these quantitative and qualitative criteria.
The sample size for the training set:
- Not Applicable. This refers to the training of an algorithm or AI model. This device is a physical product.
How the ground truth for the training set was established:
- Not Applicable. As above, this refers to algorithm training.

Summary

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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.

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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 (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)

Delayed loading
Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

· Larger Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

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. FixtureProducts	Bone ChamberImplant	Description	The Bone Chamber Implant is intended to besurgically placed in the maxillary or mandibularmolar arches for smaller implants and in themaxillary or mandibular molar areas for largerimplants. It purpose providing prosthetic support fordental restorations (Crown, bridges, andoverdentures) in partially or fully edentulousindividuals.
		Material	CP Ti Grade 4 of ASTM F67
		Wide ThreadDimension(Diameter &Total Length)	Ø4.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mmØ4.4 X 7.7, 9.2, 10.7, 12.2, 14.2 mmØ5.0 X 7.7, 9.2, 10.7, 12.2, 14.2 mmØ5.6 X 7.7, 9.2, 10.7, 12.2, 14.2 mmØ6.5 X 7.7, 9.2, 10.7, 12.2, 14.2 mmØ7.0 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 - AbutmentConnectionDiameter (mm)	Prosthesis	510(k) Number
Bone ChamberImplant	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 ImplantSystem	XPEED AnyRidge InternalImplant System	Implacil Implant System
Manufacturer	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	MegaGen Implant Co., Ltd.	Implacil De Bortoli MaterialOdontologico Ltda
Indications for UseStatement	The smaller Implant is intendedto be surgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achievedand with appropriate occlusalloading.	The AnyRidge Octa 1 ImplantSystem is intended to besurgically placed in themaxillary or mandibular archesfor the purpose of providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore a patient'schewing function in thefollowing situations and withthe clinical protocols:-Delayed loading.-Immediate loading when goodprimary stability is achievedand with appropriate occlusalloading. Larger implants arededicated for the molar region.	The XPEED AnyRidge InternalImplant System is intended tobe surgically placed in themaxillary or mandibular molarareas for the purpose providingprosthetic support for dentalrestorations (Crown, bridges,and overdentures) in partiallyor fully edentulous individuals.It is used to restore patientschewing function. Smallerimplants (less than 6.0 mm) arededicated for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Larger implants are dedicatedfor the molar region and areindicated for delayed loading	Implacil Implant System isintended for placement in themaxillary or mandibular arch toprovide support for single-unitand/or multi-unit restorations.When a one-stage surgicalapproach is applied, theImplacil Implant System isintended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading.
Design
Widest ThreadDiameter (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 AbutmentConnection	Internal Octa	Internal Octa	Internal Hex	Internal HexExternal 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 fixturewhich is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture.		It is a tapered body fixturewhich is inserted in thealveolar bone. It replaces thefunctions of the missing teethas a dental implant fixture.		It is a tapered body fixturewhich is inserted in thealveolar bone. It replaces thefunctions of the missing teethas 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 ThreadDiameter(Ø,mm)	Total Length(mm)	Model name	Widest ThreadDiameter(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.

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	Subject Device	Primary Predicate Device	Reference Device				SurfaceTreatment
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(CompatibleImplant System)	Bone Chamber Implant	Rescue Internal ImplantSystem	XPEED AnyRidge InternalImplant System	AnyRidge Octa 1 ImplantSystem	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 BortoliMaterial OdontologicoLtda	Shelf Life	5 years	5 years	5 years	5 years
Indications forUse Statement	The larger Implant isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purpose ofproviding prostheticsupport for dentalrestorations (Crown,bridges, and overdentures)in partially or fullyedentulous individuals.These implants can beused where smallerimplants have failed.It is used to restore apatient's chewing functionin the following situationsand with the clinicalprotocols:-Delayed loading.	Rescue Internal ImplantSystem is intended to besurgically placed in themaxillary or mandibularmolar areas for thepurpose of providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. These implantscan be used where smallerimplants have failed.	The XPEED AnyRidgeInternal Implant System isintended to be surgicallyplaced in the maxillary ormandibular molar areasfor the purpose providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore patients chewingfunction. Smaller implants(less than 6.0 mm) arededicated for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region and areindicated for delayedloading	The AnyRidge Octa 1Implant System is intendedto be surgically placed inthe maxillary ormandibular arches for thepurpose of providingprosthetic support fordental restorations(Crown, bridges, andoverdentures) in partiallyor fully edentulousindividuals. It is used torestore a patient's chewingfunction in the followingsituations and with theclinical protocols:-Delayed loading.-Immediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for themolar region.	Implacil Implant System isintended for placement inthe maxillary ormandibular arch toprovide support for single-unit and/or multi-unitrestorations. When a one-stage surgical approach isapplied, the ImplacilImplant System is intendedfor immediate loadingwhen good primarystability is achieved andwith appropriate occlusalloading.	Feature	- Straight / Tapered bodyshape- Submerged implant	- Submerged implant- Mose Tapered body- cutting edge with self-tapping	- Submerged implant- Tapered body- cutting edge with self-tapping	- Straight / Tapered bodyshape- 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 - presenceof chambers	Yes	No	No	No	Yes
Widest ThreadDiameter (Ø,mm) & TotalLength(mm)	• Deep threadØ5.6 X 7.7, 9.2, 10.7, 12.2,14.2 mmØ6.5 X 7.7, 9.2, 10.7, 12.2,14.2 mmØ7.0 X 7.7, 9.2, 10.7, 12.2,14.2 mm	Ø6.0 X 7.0, 8.0, 9.5, 11.0, 12.5mmØ6.5 X 7.0, 8.0, 9.5, 11.0, 12.5mmØ7.0 X 7.0, 8.0, 9.5, 11.0, 12.5mmØ8.0 X 7.0, 8.0, 9.5, 11.0,12.5 mm	• Normal threadØ4.0 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.4 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.9 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ5.4 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ5.9 X 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mm• Deep threadØ6.4 X 7.9, 9.4, 10.9, 12.4,14.4 mmØ6.9 X 7.9, 9.4, 10.9, 12.4,14.4 mmØ7.4 X 7.9, 9.4, 10.9, 12.4,14.4 mmØ7.9 X 7.9, 9.4, 10.9, 12.4,14.4 mmØ8.4 X 7.9, 9.4, 10.9, 12.4,14.4 mm	• Normal threadØ3.6 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.0 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.4 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.7 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ5.0 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mm• Deep threadØ4.0 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.4 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ4.8 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ5.0 X 7.0, 7.7, 9.2, 10.7, 12.2,14.2, 17.2 mmØ5.5 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 mmØ4.0 X 7.0, 8.0, 9.0, 10.0, 11.0,12.0, 13.0, 14.0, 15.0 mmØ5.0 X 7.0, 8.0, 9.0, 10.0, 11.0,12.0, 13.0, 14.0, 15.0 mm	Principle ofOperation	It is a tapered body fixturewhich is inserted in thealveolar bone. It replacesthe functions of themissing teeth as a dentalimplant fixture.	This product is dentalimplant which is insertedin the alveolar bone. Itreplaces the functions ofthe missing teeth as adental implant fixture.	This product is dentalimplant which is insertedin the alveolar bone. Itreplaces the functions ofthe missing teeth as adental implant fixture.	It is a tapered body fixturewhich is inserted in thealveolar bone. It replacesthe functions of themissing teeth as a dentalimplant fixture.	-
Implant-toAbutmentConnection	Internal Octa	Internal Hex	Internal Hex	Internal Octa	Internal HexExternal 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)

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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	WidestThreadDiameter(Ø,mm)	Total Length(mm)	Model name	WidestThreadDiameter(Ø,mm)	Total Length(mm)	510k	Widest ThreadDiameter / 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 diameterShorter length	0.40.2
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 diameterShorter length	0.40.2

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.

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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 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 <85>.

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.

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

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.