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K Number
K192614
Device Name
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
Manufacturer
MegaGen Implant CO., Ltd.
Date Cleared
2020-02-13

(143 days)

Product Code
NHA
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.
Device Description
Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a superstructure of a dental implant system to provide support for prosthetic restorations. It is intended to be used in implant-retained and removable overdenture restorations where the patient is fully edentulous. The subject device is consisted of the following devices: Meg-Ball Abutment, Metal Housing (Metal Cap, Retentive Ring), Meg-Loc Abutment, and Meg-Magnet Abutment.
More Information

K182091

K161689, K162867, K123988, K151789, K101890

No
The summary describes a mechanical dental implant attachment system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

No
The device is described as a superstructure of a dental implant system intended to provide support for prosthetic restorations to restore chewing function, rather than to treat or cure a disease or condition.

No

Explanation: The device is described as a superstructure of a dental implant system intended for supporting tooth replacements and restoring chewing function. Its purpose is to provide mechanical support for prosthetic restorations, not to diagnose a condition or disease.

No

The device description explicitly lists physical components (Meg-Ball Abutment, Metal Housing, Meg-Loc Abutment, Meg-Magnet Abutment) and the performance studies include physical testing (biocompatibility, surface treatment, endotoxin, sterilization, retentive force).

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

Here's why:

  • Intended Use: The intended use clearly states the device is for supporting tooth replacements to restore chewing function in the upper or lower jaw, specifically for retaining tissue-supported overdentures. This is a mechanical function within the body.
  • Device Description: The description confirms it's a "superstructure of a dental implant system to provide support for prosthetic restorations." This describes a physical component used in a dental procedure.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or treatment decisions based on laboratory testing.

The device is a dental prosthetic component, not a diagnostic tool used for testing biological samples.

N/A

Intended Use / Indications for Use

The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture.

The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.

Product codes

NHA

Device Description

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a superstructure of a dental implant system to provide support for prosthetic restorations. It is intended to be used in implant-retained and removable overdenture restorations where the patient is fully edentulous.

The subject device is consisted of the following devices.

  • Meg-Ball Attachment System (Meg-Ball Abutment, Metal Housing [Metal Cap, Retentive Ring])
  • Meg-Loc Abutment
  • Meg-Magnet Abutment

Meg-ball Abutment is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal. Meg-ball abutment has a ball shaped. It is made of Ti-6A1-4V ELI.
Metal cap has shape of cap to protect and hold the retentive ring. It is fixed into the denture and is applied to Meg-ball abutment to stabilize the denture. It is made of Ti-6A1-4V ELI.
Retentive ring has shape of ring to connect to Meg-ball abutment. It is inserted into the metal cap and serves as a buffer for the abutment and denture stabilizing, and can be replaced. It is made of Fluorinated Rubber.

Meg-Loc Abutment is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal. Meg-Loc abutment has a truncated head. It is made of Ti-6A1-4V ELI.

Meg-Magnet Abutment is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal using the magnetic force of the magnet attachment (D356767). Meg-Magnet abutment has a flat head. It is made of Stainless Steel with TiN coating.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper or lower jaw

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)

Non-Clinical Testing:

  • Biocompatibility: Evaluation performed in accordance with ISO 10993-1 for the Retentive Ring and Meg-Magnet Abutment (Cytotoxicity Test - ISO 10993-5, Oral Mucosa Irritation Test - ISO 10993-10, Skin Sensitization Test - ISO 10993-10, Acute Systemic Toxicity Test - ISO 10993-11). Biocompatibility for Meg-Loc Abutment, Meg-Ball Abutment and Metal Cap is leveraged from K123988 (AnyOne Internal Implant System).
  • Modified 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' to evaluate the TiN coated device (Surface Cross section & Coating Thickness Analysis, Component Analysis, Adhesion Grade Analysis).
  • Pyrogen and Endotoxin Test: Endotoxin testing will be conducted on every batch with a testing limit of below 0.5 EU/mL in accordance with USP 39 .
  • Sterilization validation: Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10-6).
  • Performance (Physical Properties) Test: Bench tests including retentive force have been performed in accordance with 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'. Retention testing for dental attachment was also conducted.

Clinical Testing: No clinical studies are submitted.

Key Results: The test results show that the performance of the subject device supports the substantial equivalence to the predicate device.

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

Not Found

Predicate Device(s)

K182091

Reference Device(s)

K161689, K162867, K123988, K151789, K101890

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.)

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

February 13, 2020

MegaGen Implant CO., Ltd. You Jung Kim Chief Researcher 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu. 42921 REPUBLIC OF KOREA

Re: K192614

Trade/Device Name: Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 14, 2019 Received: November 18, 2019

Dear You Jung Kim:

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.

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K192614

Device Name

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment

Indications for Use (Describe)

The Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture.

The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.

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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3

510(k) Summary

Date: Feb 13, 2020

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

You Jung Kim MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Fax: +82-53-289-3420 Tel: +82-53-222-2985 Email:rmd_ra4@imegagen.com

3. Device

| ▪ Trade Name: | Meg-Ball Attachment System, Meg-Loc Abutment,
Meg-Magnet Abutment |
|--------------------------------|----------------------------------------------------------------------|
| ▪ Common Name: | Endosseous Dental Implant Abutment |
| ▪ Classification Name: | Abutment, Implant, Dental, Endosseous |
| ▪ Classification Product Code: | NHA |
| ▪ Classification regulation: | Class II, 21 CFR 872.3630 |

4. Predicate Device

  • י Primary Predicate Device: K182091 – Osstem Abutment System
  • . Reference Devices:
    • K161689– Osstem Implant System Abutment K162867 - MagDen Dental Implant System K123988 – AnyOne Internal Implant System K151789 - LOCATOR F-Tx Implant Attachment System K101890 – Ball Abutment System

4

5. Description

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is a superstructure of a dental implant system to provide support for prosthetic restorations. It is intended to be used in implant-retained and removable overdenture restorations where the patient is fully edentulous.

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is compatible with the following FDA cleared MegaGen Implant system.

ManufacturerDevice Name510(k) NumberConnectionDiameter (mm)
MegaGen Implant
Co., Ltd.AnyRidge
Internal FixtureK110955,
K122231Internal Hex4.0, 4.4, 4.9, 5.4, 5.9,
6.4, 6.9, 7.4, 7.9, 8.4
AnyOne
Internal FixtureK123988Internal Hex3.9, 4.3, 4.8, 5.3, 5.8,
6.3, 6.8, 7.3, 7.8, 8.3
AnyRidge Octa 1
FixtureK182448Internal Octa3.3, 3.7, 4.1, 4.4, 4.8
ExFeel
Internal FixtureK052369Internal Hex4.8

The subject device is consisted of the following devices.

ComponentContent
Meg-Ball
Attachment
SystemMeg-Ball
AbutmentDescriptionMeg-ball Abutment is intended to be used in
completely edentulous jaws and connects to an
overdenture to allow its insertion and removal. Meg-
ball abutment has a ball shaped.
Material CompositionTi-6A1-4V ELI
Diameter2.91, 3.13, 3.40, 3.50 mm
Head Diameter2.25 mm
Head Length4.15 mm
Gingival Heights0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm
Total Length9.5, 10, 10.1, 10.6, 10.65, 10.75, 11, 11.15, 11.25,
11.6, 12, 12.15, 12.25, 12.6, 13, 13.15, 13.25, 13.6,
14, 14.15, 14.25, 14.6, 15, 15.15, 15.25, 15.6, 16.15,
16.25 mm
AngulationStraight
Compatible Implant SystemAnyRidge Internal Implant System
AnyOne Internal Implant System
AnyRidge Octa 1 Implant System
ExFeel Internal Implant System
Metal
HousingMetal
CapDescriptionMetal cap has shape of cap to protect and hold the
retentive ring. It is fixed into the denture and is applied
to Meg-ball abutment to stabilize the denture.
Material
CompositionTi-6A1-4V ELI
Diameter5.0 mm
Height4.0 mm
Retentive
RingDescriptionRetentive ring has shape of ring to connect to Meg-
ball abutment. It is inserted into the metal cap and
serves as a buffer for the abutment and denture
stabilizing, and can be replaced.
MaterialFluorinated Rubber

5

Composition
Diameter4.5 mm
Height1.5 mm
DescriptionMeg-Loc Abutment is intended to be used in
completely edentulous jaws and connects to an
overdenture to allow its insertion and removal. Meg-
Loc abutment has a truncated head.
Material CompositionTi-6A1-4V ELI
Diameter (Head)3.89 mm
Diameter (Body)2, 2.45, 3.14, 3.4, 3.5 mm
Meg-Loc
AbutmentGingival Height0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm
Total Length6.85, 7.35, 7.45, 7.95, 8, 8.1, 8.35, 8.5, 8.6, 8.95, 9.35,
9.5, 9.6, 9.95, 10.35, 10.5, 10.6, 10.95, 11.35, 11.5,
11.6, 11.95, 12.35, 12.5, 12.6, 12.95, 13.5, 13.6 mm
AngulationStraight
Compatible Implant SystemAnyRidge Internal Implant System
AnyOne Internal Implant System
AnyRidge Octa 1 Implant System
ExFeel Internal Implant System
DescriptionMeg-Magnet Abutment is intended to be used in
completely edentulous jaws and connects to an
overdenture to allow its insertion and removal using
the magnetic force of the magnet attachment
(D356767). Meg-Magnet abutment has a flat head.
Material CompositionStainless Steel
Surface TreatmentTiN coating
Diameter (Head)4.5, 5.0 mm
Meg-
Magnet
AbutmentDiameter (Body)2, 2.45, 3.56, 4.86 mm
Gingival Height0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8 mm
Total Length5.65, 5.85, 6.15, 6.75, 6.8, 6.9, 7.15, 7.3, 7.4, 7.75,
8.15, 8.3, 8.4, 8.75, 9.15, 9.3, 9.4, 9.75, 10.15, 10.3,
10.4, 10.75, 11.3, 11.4 mm
AngulationStraight
Compatible Implant SystemAnyRidge Internal Implant System
AnyOne Internal Implant System
AnyRidge Octa 1 Implant System
ExFeel Internal Implant System

6. Indication for use

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture.

The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.

6

7. Basis for Substantial Equivalence

Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is substantially equivalent to the predicate devices in terms of intended use, technical characteristics, function, and performance. They are made of the same material (except for the retentive ring) and have a similar design. The size range of subject device slightly differ from the predicate devices however it is very minor not affecting substantial equivalence.

The subject device is composed of the straight type abutments that are used for supporting the overdenture, while the predicate & reference devices address complete dental implant system including various fixtures and abutments. For this reason, the indication for use statements between subject and predicate devices are different but, the proposed indication is available to apply to predicate/reference devices as well, since the submission device is a sub-set of devices included in the predicate & reference device. Also, the indications for use statements of the subject device and the predicate and reference devices have the same intended to provide the provide the prosthetic support for dental restorations such as crown, bridges, and overdenture to restore patient's chewing function. This minor difference in wording does not affect the substantial equivalence of the subject device. The indication for use statement of subject device is substantially equivalent to the predicate device.

In order to demonstrate the difference does not raise any new issues, each performance test on the subject and predicate device have been performed in consideration of the worst case according to 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to figure out physical property (e.g. retentive force). Fatigue testing was not conducted based on above FDA Guidance Document because the proposed abutments is straight type. The subject abutment is intended for straight implantation, and does not receive single load, because it used for supporting the overdenture for which the load is dispersed to the full denture. The st result shows that the performance of subject device supports the substantial equivalence to the predicate device.

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

7

• Meg-Ball Abutment

| | Subject Device | Predicate Device | Reference Device
1 | Reference Device
2 | Reference Device
3 | | ExFeel Internal
Implant System | MS SA Implant
System | | | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | K192614 | K182091 | K161689 | K123988 | K101890 | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| Device Name | Meg-Ball
Abutment
For Meg-Ball Attachment
System,
Meg-Loc Abutment,
Meg-Magnet Abutment | Stud Abutment
For Osstem Abutment
System | Stud Abutment
For OSSTEM Implant System-
Abutment | Ball Abutment
For
AnyOne™ Internal Implant
System | Ball Abutment
For Ball Abutment
System | Surface
Treatment | Machined surface | Partial TiN coating | Partial TiN coating | Machined surface | Machined surface |
| Manufacturer | MegaGen Implant Co.,
Ltd. | Osstem Implant Co.,
Ltd. | Osstem Implant Co.,
Ltd. | MegaGen Implant Co.,
Ltd. | MegaGen Implant Co.,
Ltd. | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Indications for
Use Statement | Meg-Ball
Attachment System,
Meg-Loc Abutment,
Meg-Magnet
Abutment is
intended to be used
in the upper or lower
jaw and used for
supporting tooth
replacements to
restore chewing
function. Intended
for fully edentulous
jaw retaining a
tissue supported
overdenture.
The abutments in
combination with
endosseous implants
are used as the
foundation for
anchoring tooth
replacements in
either jaw. The
attachments are used
in fixed overdenture
restorations that can
be attached with a
snap-in system. | Osstem Abutment
System is intended
for use with a dental
implant to provide
support for
Prosthetic
restorations such as
crowns, bridges, or
overdentures. | The OSSTEM
Implant System -
Abutment is
intended for use
with a dental
implant to
provide support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | 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
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 Ball Abutment
Systems are used for
implant retained
mucosa-supported
restorations, such as
overdentures where
the patient is fully
edentulous in the
arch to be restored.
There are two types
of Ball Abutment
system, internal and
external type, and
the ball abutment
technique is used on
Ball Abutment
System implants in
the maxilla or
mandible. | Abutment
Angle | Straight | Straight | Straight | Straight | Straight
(External Type) |
| Design | Image: Meg-Ball Abutment Design | Image: Stud Abutment Design | Image: Stud Abutment Design | Image: Ball Abutment Design | Image: Ball Abutment Design | Principle of
Operation | This product is
generally applied to
prosthetic procedure
for overdentures.
The head part is
where connected to
overdenture with
attachment and the
screw part is
connected directly to
the endosseous
dental implant by
their threaded part. | This product is
generally applied to
prosthetic procedure
for overdentures.
The head part is
where connected to
overdenture with
attachment and the
screw part is
connected directly to
the endosseous
dental implant by
their threaded part. | This product is
generally applied to
prosthetic procedure
for overdentures.
The head part is
where connected to
overdenture with
attachment and the
screw part is
connected directly to
the endosseous
dental implant by
their threaded part. | This product is
generally applied to
prosthetic procedure
for overdentures.
The head part is
where connected to
overdenture with
attachment and the
screw part is
connected directly to
the endosseous
dental implant by
their threaded part. | This product is
generally applied to
prosthetic procedure
for overdentures.
The head part is
where connected to
overdenture with
attachment and the
screw part is
connected directly to
the endosseous
dental implant by
their threaded part. |
| Diameter | 2.91, 3.13, 3.4, 3.5
mm | 3.5 mm | 3.5 mm | 3.4 mm | 2.85, 3.5, 4. 1, 5.0,
6.0mm | Substantial Equivalence Discussion | | | | | |
| Head
Diameter | 2.25 mm | 1.7 mm | 2.25mm | 2.25 mm | 2.25mm | | | | | | |
| Head Length | 4.15 mm | 2.5 mm | 3.35mm | 3.8mm | 4.0 mm | | | | | | |
| Total Length | 9.5, 10, 10.1, 10.6,
10.65, 10.75, 11,
11.15, 11.25, 11.6,
12, 12.15, 12.25,
12.6, 13, 13.15,
13.25, 13.6, 14,
14.15, 14.25, 14.6,
15, 15.15, 15.25,
15.6, 16.15, 16.25 | 8.5, 8.9, 9.5, 9.9,
10.5, 10.9, 11.5,
11.9, 12.5, 12.9,
13.5, 13.9 | 9.35, 9.75, 10.35,
10.75, 11.35, 11.75,
12.35, 12.75, 13.35,
13.75, 14.35, 14.75 | 10.25, 11.5, 13.5,
15.5 | 9.15, 9.65, 9.85,
11.1, 11.65, 11.85,
13.1, 13.65, 13.85,
15.1 | | | | | | |
| Compatible
Implant
System | AnyRidge Internal
Implant System
AnyOne Internal
Implant System
AnyRidge Octa 1
Implant System | TS SA Fixture
System
SS SA Fixture
System
US SA Fixture
System | TS Fixture System | AnyOne Internal
Implant System | ExFeel Implant
System
EZ Plus Implant
System
Rescue External
Implant System | | | | | | |

8

Similarities 1.

The subject device has similar characteristic for the following compared to the predicate/reference devices. Design, Head Diameter, Material, Surface Treatment, Sterilization, Angle and Principle of Operation

2. Differences

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

  • Indications for Use See Section 7 (page 4/13) .
    Diameter, Head Diameter and Head Length

The diameter of 3.4, 3.5mm in subject device is same size as predicate/reference devices. The diameter range of the subject device is slightly different with predicate/reference devices by addition of diameter 2.91mm in subject device but it can be covered by reference device 3 and the variety of the size can be possible to operate more precise treatment to meet each patient's condition. The head length of subject device is slightly longer than predicate/reference devices. However, all of these size differences do not cause a change in the intended use of the size difference is very minor.

3. Discussion

In order to demonstrate the differences do not raise in substantial equivalence, each performance test on the subject and predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate attachment as intended. Fatigue testing is not considered based on FDA Guidance Document being as proposed abutments is straight type. The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting the overdenture that means load is dispersed to the full denture. The test result shows that the performance of subject device supports the substantial equivalence to the predicate device.

In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have in common in indication for use, design, material, function; and the differences are minor and theses have been identified via the performance test the differences do not impact substantial equivalence.

9

Metal Cap •

Subject DevicePredicate DeviceReference Device 1Reference Device 2
510(k) NumberK192614K182091K161689K182091
Device NameMetal Cap
For Meg-Ball Attachment System,
Meg-Loc Abutment,
Meg-Magnet AbutmentO-ring Retainer Cap
For Osstem Abutment SystemO-ring Retainer Cap
For OSSTEM Implant System-AbutmentPort Male Cap
For Osstem Abutment System
ManufacturerMegaGen Implant Co., Ltd.Osstem Implant Co., Ltd.Osstem Implant Co., Ltd.Osstem Implant Co., Ltd.
Indications for
Use StatementThe Meg-Ball Attachment
System, Meg-Loc
Abutment, Meg-Magnet
Abutment is intended to be
used in the upper or lower
jaw and used for
supporting tooth
replacements to restore
chewing function.
Intended for fully
edentulous jaw retaining a
tissue supported
overdenture. The
abutments in combination
with endosseous implants
are used as the foundation
for anchoring tooth
replacements in either jaw.
The attachments are used
in fixed overdenture
restorations that can be
attached with a snap-in
system.Osstem Abutment System
is intended for use with a
dental implant to provide
support for Prosthetic
restorations such as
crowns, bridges, or
overdentures.The OSSTEM Implant
System - Abutment is
intended for use with a
dental implant to
provide support for
prosthetic restorations
such as crowns, bridges, or
overdentures.Osstem Abutment System
is intended for use with a
dental implant to provide
support for Prosthetic
restorations such as
crowns, bridges, or
overdentures.
DesignImage: Metal CapImage: O-ring Retainer CapImage: O-ring Retainer CapImage: Port Male Cap
Diameter5 mm3.95mm5 mm5.5 mm
Height4 mm2.9 mm3.9mm2.25 mm
MaterialTi-6A1-4V ELITitanium Gr. 3Titanium Gr. 3Ti-6A1-4V ELI
Surface
treatmentMachined surfaceMachined surfaceMachined surfaceMachined surface
SterilizationNon-sterileNon-sterileNon-sterileNon-sterile
Principle of
operationThis product is generally
applied to prosthetic
procedure for
overdentures.
It is inserted and fixed into
denture; and applied to ball
type abutment to stabilize
the overdenture.This product is generally
applied to prosthetic
procedure for
overdentures.
It is inserted and fixed into
denture; and applied to
stud type abutment to
stabilize the overdenture.This product is generally
applied to prosthetic
procedure for
overdentures.
It is inserted and fixed into
denture; and applied to
stud type abutment to
stabilize the overdenture.This product is generally
applied to prosthetic
procedure for
overdentures.
It is inserted and fixed into
denture; and applied to port
type abutment to stabilize
the overdenture.
Substantial Equivalence Discussion
1. Similarities
The subject device has similar characteristic for the following compared to the predicate/reference devices.
Design, Diameter, Material, Surface Treatment, Sterilization and Principle of Operation
2. Differences
The subject device has the different characteristic for the following compared to the predicate/reference devices.
Indications for Use - See Section 7 (page 4/13)
  • Height
    The height of subject device is slightly longer than predicate devices; there is a 0.1mm difference between reference device | | | | |
    | | Subject Device | Predicate Device | Reference Device | |
    | 510(k) Number | K192614 | K182091 | K161689 | |
    | Device Name | Retentive Ring
    For Meg-Ball Attachment System,
    Meg-Loc Abutment,
    Meg-Magnet Abutment | O-ring
    For Osstem Abutment System | O-ring
    For OSSTEM Implant System-Abutment | |
    | Manufacturer | MegaGen Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | |
    | Indications for Use
    Statement | The Meg-Ball Attachment System,
    Meg-Loc Abutment, Meg-Magnet
    Abutment is intended to be used in
    the upper or lower jaw and used for
    supporting tooth replacements to
    restore chewing function. Intended
    for fully edentulous jaw retaining a
    tissue supported overdenture.
    The abutments in combination with
    endosseous implants are used as the
    foundation for anchoring tooth
    replacements in either jaw. The
    attachments are used in fixed
    overdenture restorations that can be
    attached with a snap-in system. | Osstem Abutment System is
    intended for use with a dental
    implant to provide support for
    Prosthetic restorations such as
    crowns, bridges, or overdentures. | The OSSTEM Implant System -
    Abutment is intended for use with a
    dental implant to
    provide support for prosthetic
    restorations such as crowns,
    bridges, or overdentures. | |
    | Design | Image: Retentive Ring | Image: O-ring | Image: O-ring | |
    | Diameter | 4.5mm | 3.5 mm | 4.6mm | |
    | Height | 1.5 mm | Not known | 1.5 mm | |
    | Material | Fluorinated Rubber | NBR (Acrylonitrile & Butadiene
    Polymer) | NBR (Acrylonitrile & Butadiene
    Polymer) | |
    | Sterilization | Non-sterile | Non-sterile | Non-sterile | |
    | Principle of
    operation | This product is generally applied to
    prosthetic procedure for
    overdentures.
    It is inserted into the Metal Cap and
    serves as a buffer for ball type
    abutment and denture stabilizing. | This product is generally applied to
    prosthetic procedure for
    overdentures.
    It is inserted into the O-ring Retainer
    Cap and serves as a buffer for stud
    type abutment and denture
    stabilizing. | This product is generally applied to
    prosthetic procedure for
    overdentures.
    It is inserted into the O-ring Retainer
    Cap and serves as a buffer for stud
    type abutment and denture
    stabilizing. | |
    | Substantial Equivalence Discussion | | | | |
    | 1.
    Similarities
    The subject device has similar characteristic for the following compared to the predicate devices. | | | | |
    | Meg-Loc Abutment
    ● | | | | |
    | | Subject Device | Predicate Device | Reference Device | Reference Device |
    | 510(k) No. | K192614 | K182091 | K123988 | K151789 |
    | Device | Meg-Loc Abutment | Port Abutment | Meg-Rhein Abutment | LOCATOR F-Tx |
    | Name | For Meg-Ball Attachment
    System, Meg-Loc Abutment,
    Meg-Magnet Abutment | For Osstem Abutment
    System | For AnyOne™ Internal
    Implant System | For LOCATOR F-Tx
    Attachment System |
    | Manufacturer | MegaGen Implant
    Co., Ltd. | Osstem Implant
    Co., Ltd. | MegaGen Implant
    Co., Ltd. | Zest Anchors, LLC |
    | Indications for
    Use Statement | The Meg-Ball Attachment
    System, Meg-Loc
    Abutment, Meg-Magnet
    Abutment is intended to be
    used in the upper or lower
    jaw and used for
    supporting tooth
    replacements to restore
    chewing function. Intended
    for fully edentulous jaw
    retaining a tissue supported
    overdenture.
    The abutments in
    combination with
    endosseous implants are
    used as the foundation for
    anchoring tooth
    replacements in either jaw.
    The attachments are used in
    fixed overdenture
    restorations that can be
    attached with a snap-in
    system. | Osstem Abutment System
    is intended for use with a
    dental implant to provide
    support for Prosthetic
    restorations such as crowns,
    bridges, or overdentures. | 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 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 LOCATOR® F-Tx
    Attachment System is
    designed to support fixed,
    partial or full arch
    restorations on endosseous
    dental implants in the
    mandible or maxilla for the
    purpose of restoring
    masticatory function. It is
    used in fixed hybrid
    restorations that can be
    attached with a
    snap-in system. |
    | Design | | | | |
    | Diameter | 3.89 mm | 3.5, 3.7, 4.1, 4.8, 5.1 mm | 3.4 mm | 3.0 mm to 7.0 mm |
    | Gingival
    Height | 0.3, 0.8, 1.8, 2.8, 3.8, 4.8,
    5.8mm | 1, 2, 3, 4, 5, 6, 7 mm | 0.3, 1.3, 3.3, 5.3mm | 1, 2, 3, 4, 5, 6 mm |
    | Total Length | 6.85, 7.35, 7.45, 7.95,
    8, 8.1, 8.35, 8.5, 8.6,
    8.95, 9.35, 9.5, 9.6,
    9.95, 10.35, 10.5, 10.6,
    10.95, 11.35, 11.5, 11.6,
    11.95, 12.35, 12.5, 12.6,
    12.95, 13.5, 13.6 | Unknown | 8.4, 8.9, 9.9, 10.9, 11.9,
    12.9, 13.9 | Unknown |
    | Compatible
    Implant
    System | AnyRidge Internal
    Implant System
    AnyOne Internal Implant
    System
    AnyRidge Octa 1 Implant
    System
    ExFeel Internal Implant
    System | TS SA Fixture System
    SS SA Fixture System
    US SA Fixture System
    MS SA Implant System | AnyOne Internal Implant
    System | Astra Tech
    BioHorizons
    Biomet 3i
    Camlog
    Dentsply
    MIS Implants
    Nobel Biocare
    Straumann
    Zimmer |
    | Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
    | Surface
    Treatment | Machined surface | Partial TiN coating | Machined surface | TiCN or TiN coating |
    | Sterilization | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
    | Abutment
    Angle | Straight | Straight | Straight | Straight |
    | Principle of
    Operation | This product is generally
    applied to prosthetic | This product is generally
    applied to prosthetic | This product is generally
    applied to prosthetic | This product is generally
    applied to prosthetic |
    | | procedure foroverdentures.
    The head part is where
    connected to overdenture
    with attachment and the
    screw part is connected | procedure foroverdentures.
    The head part is where
    connected to overdenture
    with attachment and the
    screw part is connected | procedure foroverdentures.
    The head part is where
    connected to overdenture
    with attachment and the
    screw part is connected | procedure foroverdentures.
    The head part is where
    connected to overdenture
    with attachment and the
    screw part is connected |
    | | directly to the endosseous
    dental implant by their
    threaded part. | directly to the endosseous
    dental implant by their
    threaded part. | directly to the endosseous
    dental implant by their
    threaded part. | directly to the endosseous
    dental implant by their
    threaded part. |
    | | Substantial Equivalence Discussion | | | |
    | 1. | Similarities
    The subject device has similar characteristic for the following compared to the predicate/reference devices.
  • Design, Material, Surface Treatment, Sterilization, Angle and Principle of Operation | | | |
    | 2. | Differences
    The subject device has the different characteristic for the following compared to the predicate/reference devices.
  • Indications for Use - See Section 7 (page 4/13)
  • Diameter and Gingival Height
  • The diameter of subject device is slightly different with predicate/reference devices however the subject device lies within the
    range of the predicate device. The gingival height range of the subject device is slightly different with predicate/reference
    devices however the subject device lies within the combined range of the predicate/reference devices. Also, these differences
    do not cause a matter in substantial equivalence since size difference is minor. | | | |
    | 3. | Discussion
    In order to demonstrate the differences do not raise an issue in substantial equivalence, each performance test on the subject
    and predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate attachment as
    intended. Fatigue testing is not considered based on FDA Guidance Document being as proposed abutments is straight type.
    The subject abutment is intended for straight implantation, and is not received single load, because it used for supporting the
    overdenture that means load is dispersed to the full denture. The test result shows that the performance of subject device is
    verified and supports the substantial equivalence to the predicate device.
    In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have
    in common in indication for use, design, material, function; and the differences have been identified
    via the performance test and the differences do not impact substantial equivalence. | | | |

Discussion 3.

In order to demonstrate the difference does not raise an issue in substantial equivalence, each performance test on the subject and predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate abutment as intended. The test result shows that the performance of subject device supports the substantial equivalence to the predicate device.

In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have in common in indication for use, design, material, function; and the differences are minor and theses have been identified via the performance test the differences do not impact substantial equivalence.

10

• Retentive Ring

Differences

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

  • Indications for Use See Section 7 (page 4/13)
  • -Diameter

The diameter of subject device is slightly different with predicate devices; there is a 0.1mm difference between reference device and the subject device lies within the combined range of the predicate devices and reference device. This difference does not cause a matter in substantial equivalence since the size difference is minor.

-Material

The material of subject device is different with predicate devices but the biocompatibility testing has been performed in accordance with ISO 10993-1.

3. Discussion

In order to demonstrate the differences do not raise in substantial equivalence, each performance test on the subject and predicate device have been performed to figure out physical property (e.g. retentive force) with appropriate attachment and abutment as intended. The biocompatibility test has been conducted as well for demonstrating the substantial equivalence of the material difference. The tests result show that the performance and biocompatibility of subject device support the substantial equivalence to the predicate device.

In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have in common in indication for use, design, function, etc.; and the differences have been identified via the tests and do not impact substantial equivalence.

11

12

10/13Pages

K192614

13

Subject DevicePredicate Device
510(k) No.K192614K162867
Device NameMeg-Magnet Abutment
For Meg-Ball Attachment System, Meg-Loc Abutment,
Meg-Magnet AbutmentMagDen Mini Abutment
for MagDen Dental Implant System
ManufacturerMegaGen Implant Co., Ltd.SHINHUNG MST Co., Ltd.
Indications for Use StatementThe Meg-Ball Attachment System, Meg-Loc
Abutment, Meg-Magnet Abutment is intended to be
used in the upper or lower jaw and used for
supporting tooth replacements to restore chewing
function. Intended for fully edentulous jaw retaining
a tissue supported overdenture. The abutments in
combination with endosseous implants are used as
the foundation for anchoring tooth replacements in
either jaw. The attachments are used in fixed
overdenture restorations that can be attached with a
snap-in system.The MagDen Dental Implant System 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, and to restore the
patient's chewing function.
DesignImage: Meg-Magnet Abutment designImage: MagDen Mini Abutment design
Diameter4.5, 5.0mm3.8, 4.0, 4.2 mm
Gingival Height0.3, 0.8, 1.8, 2.8, 3.8, 4.8, 5.8mmNot Known
Total Length5.65, 5.85, 6.15, 6.75, 6.8, 6.9, 7.15, 7.3, 7.4,
7.75, 8.15, 8.3, 8.4, 8.75, 9.15, 9.3, 9.4, 9.75,
10.15, 10.3, 10.4, 10.75, 11.3, 11.44.3, 4.8, 5.3, 5.5, 5.8, 6.0, 6.3, 6.5, 6.8, 7.0, 7.3,
7.5, 7.8, 8.0, 8.5, 9.0
Compatible Implant SystemAnyRidge Internal Implant System
AnyOne Internal Implant System
AnyRidge Octa 1 Implant System
ExFeel Internal Implant SystemMagDen Dental Implant System
MaterialStainless SteelStainless Steel
Surface TreatmentTiN coatingTiN coating
SterilizationNon-sterileNon-sterile
Abutment AngleStraightStraight
Principle of OperationThis product is generally applied to prosthetic
procedure for overdentures. The head part is where
connected to overdenture with attachment and the
screw part is connected directly to the endosseous
dental implant by their threaded part.This product is generally applied to prosthetic
procedure for overdentures. The head part is where
connected to overdenture with attachment and the
screw part is connected directly to the endosseous
dental implant by their threaded part.
Substantial Equivalence Discussion
1. Similarities
The subject device has similar characteristic for the following compared to the predicate device.
Design, Material, Surface Treatment, Sterilization, Angle and Principle of Operation.
2. Differences
The subject device has the different characteristic for the following compared to the predicate device.
  • Indications for Use – See Section 7 (page 4/13)
  • Diameter
    The diameter of subject device is slightly larger than predicate device, however it does not cause a matter in
    substantial equivalence since the size difference is minor. | | |
    | 3. Discussion
    In order to demonstrate the difference does not raise an issue in substantial equivalence, each performance test
    on the subject and predicate device have been performed to figure out physical property (e.g. retentive force)
    with appropriate attachment as intended. Fatigue testing is not considered based on FDA Guidance Document
    being as proposed abutments is straight type. The subject abutment is intended for straight
    implantation, and is not received single load, because it used for supporting the overdenture that means load is | | |

Meg-Magnet Abutment .

14

dispersed to the full denture. The test result shows that the performance of subject device supports the substantial equivalence to the predicate device.

In conclusion, the subject device is substantially equivalent to the predicate device since the subject and predicate device have in common in indication for use, design, material, function; and the differences are minor and theses have been identified via the performance test the differences do not impact substantial equivalence.

15

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" for the Retentive Ring and Meg-Magnet Abutment. Cytotoxicity Test - ISO 10993-5

Oral Mucosa Irritation Test - ISO 10993-10

Skin Sensitization Test - ISO 10993-10

Acute Systemic Toxicity Test - ISO 10993-11

The biocompatibility testing for the Meg-Loc Abutment, Meg-Ball Abutment and Metal Cap is leveraged from the AnyOne Internal Implant System (K123988) since these have same material composition, manufacturing process and patient contacting parts as predicate devices.

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' to evaluate the TiN coated device:

  • · Surface Cross section & Coating Thickness Analysis, Component Analysis, Adhesion Grade Analysis

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

The subject device is supplied in non-sterile state. Sterilization validating testing for steam sterilization by the user has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10-6).

Performance (Physical Properties) Test

The bench tests including retentive force have been performed in accordance with 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices. The retention testing for dental attachment has been conducted as well.

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 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is substantially equivalent to the predicate device as herein.