CSM Submerged3-L Implant System

K173141 · Csm Implant · DZE · Sep 19, 2018 · Dental

Device Facts

• Record ID: K173141
• Device Name: CSM Submerged3-L Implant System
• Applicant: Csm Implant
• Product Code: DZE · Dental
• Decision Date: Sep 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

Device Story

Dental implant system comprising titanium fixtures and various abutments (healing, cementation, angled, retainer, temporary). Fixtures inserted into jawbone to support prosthetic restorations; abutments connect fixtures to crowns or overdentures. Used in dental clinics by clinicians. Fixtures feature RBM and laser surface treatment; internal hex and Morse taper connection. System provides mechanical support for dental prosthetics; facilitates restoration of edentulous sites. Benefits include stable foundation for dental replacements.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, irritation, sensitization, acute systemic, genotoxicity), end-user steam sterilization validation, and fatigue testing per ISO 14801. Accelerated aging testing per ASTM F1980-07 was leveraged from predicate K102635.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136-13), Polyamide 6.6. Surface: RBM + Laser. Connection: Internal hex and Morse taper. Sterilization: Gamma (fixtures), steam (abutments). Dimensions: Fixture diameters 3.62-5.95mm, lengths 7.3-14.3mm.

Indications for Use

Indicated for single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. Intended for delayed loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CSM Submerged-L Implant System (K102635)

Reference Devices

• BioHorizons Tapered Internal Implants (K143022)
• CSM Internal-R Implant System (K120043)
• HU/HS/HG PROSTHETIC SYSTEM (K081575)
• Karator (K112787)
• K052272

Submission Summary (Full Text)

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September 19, 2019

CSM Implant % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K173141

Trade/Device Name: CSM Submerged3-L Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 17, 2018 Received: August 22, 2018

Dear April Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mary S. Runner -S3

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173141

Device Name CSM Submerged3-L Implant System

#### Indications for Use (Describe)

The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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#### 510(k) Summary

### Submitter

CSM Implant Sung Am Cho B205 Techno B/D, Kyung-Pook National Univ. 47, Gyeongdae-ro 17gil, Buk-gu, Daegu 41566 Republic of Korea Email: [e-mail] Tel. [phone] Fax. [phone]

### Device Information

### Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

- . Trade Name: CSM Submerged3-L Implant System
- . Common Name: Endosseous dental implant
- Classification Name: Endosseous dental implant
- Primary Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- . Date prepared: 09/17/2018

### Predicate Information

Primary Predicate: K102635, CSM Submerged-L Implant System by CSM Implant

Reference Predicate: K143022, BioHorizons Tapered Internal Implants by BioHorizons Implant System Inc. K120043, CSM Internal-R Implant System by CSM Implant K081575, HU/HS/HG PROSTHETIC SYSTEM by Osstem Implant K112787, Karator by KJ Meditech Co, Ltd.

### Device Description

The CSM Submerged3-L Implant System is composed of dental fixtures (Sub3 Fixture) and various abutments such as Healing Abutment, Cementation Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Abutment Screw, Submerged Cover Screw, Retainer Abutment, Retainer Cap, Retainer Retention Male, and Temporary Abutment (Hex, Non-Hex).

There is no vertical anti-rotation slot in our fixtures. When it comes to anti-rotational feature, it is 11 °, which is internal hexagonal feature. Hence. 4.0. 4.8. 5.2. 5.6. 6.0 size fixtures have 2.5 hexagonal features, different from fixture with 3.6 diameter, which has 2.1 double hexagonal feature. The fin of submerged 3 fixtures is V-shape. In addition, a straight flat axial surface is on our fixture, functioning as tapering part.

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In case of abutments, 2.5 and 2.1 hexagonal features are usually used.

The Sub3 fixtures and screws are made of Ti 6A1 4V ELI (Conforming to ASTM Standard F-136) and dental abutment is made of Ti-6A1-4V ELI (ASTM F136), POLYAMIDE 6.6.

The surface of the fixtures is treated with RBM (Resorbable Blast Media) and Laser.

The diameters of the CSM Submerged3-L Implants are Ø 3.62mm, 4.35mm, 4.75mm, 5.15mm, 5.55mm, 5.95mm and the lengths of the CSM Submerged3-L Implants are 7.3mm, 8.3mm, 9.3mm, 10.3mm, 11.3mm, 12.3mm, 13.3mm, 14.3mm.

The dimension of each abutment ranges as below:(The tolerance of all products is ±0.03)

- Healing Abutment: Ø 4.02mm, 4.5mm, 6.5mm (D) X 8.25mm, 8.75mm, 9.75mm, ● 10.35mm, 10.75mm, 11.75mm, 12.35mm, 12.75mm (L)
- Cementation Abutment: Ø 4.5mm, 5.5mm, 6.5mm (D) X 8.0mm, 8.5mm, 9.0mm, 9.5mm, ● 10.5mm, 11.5mm, 12.5mm, 13.5mm (L)
- Angled Abutment: Ø 4.0mm, 4.5mm, 5.5mm (D) X 9.0mm, 9.5mm, 10.0mm, 10.3mm, ● 10.4mm, 10.5mm, 11.3mm, 11.5mm, 12.3mm, 12.3mm, 13.3mm, 13.5mm (L) with 15° and 20°
- . Abutment Screw: Ø 2.1mm, 2.33mm (D) X 8.3mm, 10.0mm (L)
- Submerged Cover Screw: Ø 2.83mm, 3.33mm (D) X 6.0mm, 6.5mm (L) ●
- Retainer Abutment: Ø 3.9mm (D) X 7.15mm, 7.65mm, 7.9mm, 8.65mm, 8.9mm, ● 9.65mm, 9.9mm, 10.65mm, 10.9mm, 11.65mm, 11.9mm, 12.9mm, 13.65mm, 13.9mm, 14.65mm, 14.9mm, 15.65mm, 15.9mm, 16.65mm, 16.9mm (L)
- Retainer Cap: Ø 5.45mm (D) X 2.4mm (L) ●
- Retainer Retention Male: Ø 4.7mm (D) X 1.85mm, 2.06mm (L) ●
- Temporary Abutment: Ø 4.5mm, 5.5mm (D) X 12.8mm, 13.8mm, 13.8mm, 14.8mm, 15.8mm, ● 16.8mm (L)

The implant-abutment connection is internal hex and Morse taper level.

Implant-fixture and submerged cover screw are packed together and provided sterile. The abutments are provided non-sterile and must be sterilized before use.

#### Indication for Use

The CSM Submerged3-L Implant System is intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

### Materials:

The Sub3 fixtures and screws are made of Ti-6Al-4V ELI (Conforming to ASTM Standard F136-13) and dental abutments are made of Ti-6AI-4V ELI (Conforming to ASTM Standard F136-13), POLYAMIDE 6.6.

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# Summary of Technological Characteristics

# 1) Fixtures

| 1) Fixtures | | | | |
|-------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Subject Device | Primary Predicate | Reference Predicate |
| | 510(K) Number | K173141 | K102635 | K143022 |
| Device Name | | CSM Submerged3-L<br>Implant System | CSM Submerged-L<br>Implant System | BioHorizons Tapered Internal<br>Implants |
| | Manufacturer | CSM Implant | CSM Implant | BioHorizons<br>Implant Systems, Inc. |
| | Indications for Use | The CSM Submerged3-L<br>Implant System is<br>intended for use in<br>support of single or<br>multiple-unit restorations<br>and partial or fully<br>edentulous mandibles<br>and maxilla. This system<br>is intended for delayed<br>loading. | CSM Implants are<br>intended for use in<br>support of single or<br>multiple-unit restorations<br>and partial or fully<br>edentulous mandibles<br>and maxilla. This system<br>is intended for delayed<br>loading. | Bio Horizons Tapered Internal<br>Implants are intended for use in<br>the mandible or maxilla as an<br>artificial root structure for single<br>tooth replacement or for fixed<br>bridgework and dental retention.<br>Bio Horizons Tapered Internal<br>Implants may be restored<br>immediately<br>I) with a temporary prosthesis<br>that is not in<br>functional occlusion, or<br>2) when splinted together for<br>multiple tooth replacement, or<br>when stabilized with an<br>overdenture supported by<br>multiple implants |
| | Appearance | Image: CSM Submerged3-L Implant | Image: CSM Submerged-L Implant | Image: BioHorizons Tapered Internal Implant |
| | Material | Ti-6Al-4V ELI<br>(ASTM-F136) | Ti-6Al-4V ELI<br>(ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| | Sterilization | Gamma | Gamma | Gamma |
| | Surface Treatment | RBM(Resorbable<br>Blasting Media) + Laser | RBM(Resorbable<br>Blasting Media) + Laser | Implant- RBT<br>Collar- Laser-Lok or RBT |
| Implant | Diameter | 3.62mm, 3.95mm,<br>4.35mm, 4.75mm,<br>5.15mm,5.55mm,<br>5.95mm | 3.5-6.0mm | 3.4mm, 3.8mm, 4.6mm |
| | Length | 7.3mm, 8.3mm, 9.3mm,<br>10.3mm, 11.3mm,<br>12.3mm, 13.3mm,<br>14.3mm | 7-14mm | 9mm, 10.5mm, 12mm, 15mm,<br>18mm |
| connection | | Internal | Internal | Internal |
| Shelf Life | | 5 years | 5 years | 5 years |
| | Principle of<br>Operation | Dental implant that can<br>be inserted on a jawbone<br>as a material for dental<br>surgery to support | Dental implant that can<br>be inserted on a jawbone<br>as a material for dental<br>surgery to support | Dental implant that can be<br>inserted on a jawbone as a<br>material for dental surgery to<br>support |

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| Similarities | The indications for use, material, general shape design, dimension, surface treatment,<br>Principle of operation, shelf life and sterilization method between the CSM Submerged3-L |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant System and the predicate devices are identical. |
| Differences | Fixture's micro-threaded part: The primary predicate, K102635 has micro threaded part on<br>the fixture whereas the subject device has no micro thread part. To support this<br>discrepancy, we chose K143022 as a reference predicate. Accordingly, we can claim the<br>substantially equivalence of the CSM Submerged3-L Implant System to predicate devices. |

### 2) Abutments

- K102635, CSM Submerged-L Implant System by CSM Implant ●
- K120043, CSM Internal-R Implant System by CSM Implant ●
- K081575, HU/HS/HG PROSTHETIC SYSTEM by Osstem Implant ●
- K112787, Karator by KJ Meditech Co, Ltd. ●

<Healing Abutment>

| | Subject Device | Predicate Device |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | CSM Submerged-L |
| | Implant System | Implant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | CSM Implants are intended for use in<br>support of single or multiple-unit<br>restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.02mm, 4.5mm, 5.5mm, 6.5mm | 4.02mm, 4.52mm, 5.52mm, 6.52mm |
| Length | 8.25mm, 8.75mm, 9.75mm, 10.35mm,<br>10.75mm, 11.75mm, 12.35mm,<br>12.75mm | 8.55mm, 8.75mm, 9.25mm, 9.35mm,<br>10.75mm, 11.35mm, 11.75mm,<br>12.75mm |
| Appearance | | |
| Principle Operation | Linked to fixture, this has covered the<br>joint of fixture until gingiva recovers. | Linked to fixture, this has covered the<br>joint of fixture until gingiva recovers. |
| Similarities | The indications for use, material, general shape design, dimension, surface<br>treatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from the<br>predicate device. However, the predicate device includes healing abutments that<br>meet or exceed the diameter and total height range compared to the dimensions of<br>the subject device. Therefore, the subject device is substantially equivalent. | |

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### <Cementation Abutment>

| | Subject Device | Predicate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L | CSM Submerged-L |
| | Implant System | Implant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | CSM Implants are intended for use in<br>support of single or multiple-unit<br>restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.5mm, 5.5mm, 6.5mm | 4.0mm, 4.5mm, 5.5mm, 6.5mm |
| Length | 8.0mm, 8.5mm, 9.0mm, 9.5mm,<br>10.5mm, 11.5mm, 12.5mm, 13.5mm | 8.8mm, 9.45mm, 9.5mm, 10.3mm,<br>10.45mm, 11.3mm, 11.45mm, 12.3mm |
| Appearance | Image: Abutment | Image: Abutment |
| Principle Operation | Abutment used to fix crown, after being<br>engaged with fixture. | Abutment used to fix crown, after being<br>engaged with fixture. |
| Similarities | The indications for use, material, general shape design, dimension, surface<br>treatment, Principle of operation, and shelf life are identical. | |
| Differences | The length and diameters of two devices are slightly different. However, the<br>dimensional differences of these devices do not have any influence on the<br>Substantial equivalence, since it is within the legend of predicate, and the<br>indications, principle of operations and raw material are identical. | |

<Angled Abutment>

| <Aligned Abutment> | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L<br>Implant System | CSM Submerged-L<br>Implant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | CSM Implants are intended for use in<br>support of single or multiple-unit<br>restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 4.0mm, 4.5mm, 5.5mm | 4.5~5.5mm |
| Length | 9.0mm, 9.4mm, 9.5mm, 10.0mm,<br>10.3mm,10.4mm,10.5mm,11.3mm,<br>11.4mm, 11.5mm, 12.3mm, 12.5mm,<br>13.3mm, 13.5mm | 15.31mm |

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| Appearance | Image: dental abutment | Image: dental abutment |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Angulation | 15°, 20° | 15°, 20° |
| Principle Operation | Abutment used to form right connection<br>between crown and fixture inserted<br>diagonally | Abutment used to form right connection<br>between crown and fixture inserted<br>diagonally |
| Similarities | The indications for use, material, general shape design, dimension, surface<br>treatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from the<br>predicate device. However, the predicate device includes Angled Abutments that<br>meet or exceed the diameter and total height range compared to the dimensions of<br>the subject Angled Abutments. Therefore, the subject device is substantially<br>equivalent. | |

### <Abutment Screw>

| | Subject Device | Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L<br>Implant System | CSM Submerged-L<br>Implant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | CSM Implants are intended for use in<br>support of single or multiple-unit<br>restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 2.1mm, 2.33mm | 2.1mm, 2.33mm |
| Length | 8.3mm, 10.0mm | 8.6mm, 10.8mm |
| Appearance | Image: Screw | Image: Screw |
| Principle Operation | Screw used to link abutment to fixture | Screw used to link abutment to fixture |
| Similarities | The indications for use, material, general shape design, dimension, surface<br>treatment, Principle of operation, and shelf life are identical. | |
| Differences | The diameters and lengths of the subject device are slightly different from the<br>predicate device. However, the predicate device includes Abutment screws that<br>meet or exceed the diameter and total height range compared to the dimensions of<br>the subject Abutment Screws. Therefore, the subject device is substantially<br>equivalent. | |

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### <Submerged Cover Screw>

| | Subject Device | Predicate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K102635 |
| Device Name | CSM Submerged3-L<br>Implant System | CSM Submerged-L<br>Implant System |
| Manufacturer | CSM Implant | CSM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | CSM Implants are intended for use in<br>support of single or multiple-unit<br>restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6A1-4V ELI (ASTM-F136) |
| Diameter | 2.83mm, 3.33mm | 2.83mm, 3.33mm |
| Length | 6.0mm, 6.5mm | 6mm, 6.5mm |
| Appearance | | |
| Principle Operation | Screw used to cover the joint of fixture<br>to prevent foreign matter from entering. | Screw used to cover the joint of fixture<br>to prevent foreign matter from entering. |
| Similarities | The indications for use, material, general shape design, dimension, surface<br>treatment, Principle of operation, and shelf life are identical. | |
| Differences | These two products are substantially identical. | |

## <Retainer Abutment>

| | Subject Device | Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K112787 |
| Device Name | CSM Submerged3-L<br>Implant System | Kerator |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L Implant System is<br>intended for use in support of single or<br>multiple-unit restorations and partial or fully<br>edentulous mandibles and maxilla. This<br>system is intended for delayed loading. | The Kerator is appropriate for use<br>with overdentures or partial<br>dentures retained in whole or in<br>part by endosseous implants in the<br>mandible or maxilla. |
| Material | Ti-6Al-4V ELI (ASTM-F136) | Ti-6Al-4V ELI (ASTM-F136) |
| Diameter | 3.9mm | 3.86mm |
| Length | 7.15mm, 7.4mm, 7.65mm, 7.9mm, 8.65mm,<br>8.9mm, 9.65mm, 9.9mm, 10.65mm, 10.9mm,<br>11.65mm, 11.9mm, 12.65mm, 12.9mm,<br>13.65mm, 13.9mm, 14.65mm, 14.9mm,<br>15.65mm, 15.9mm, 16.65mm, 16.9mm | 9mm,9.6mm |
| Appearance | Image: CSM Submerged3-L Implant | Image: Kerator Implant |
| Principle Operation | Abutment used to link overdenture to gingiva. | Abutment used to link overdenture<br>to gingiva. |

{10}------------------------------------------------

| Similarities | The main similarities between these two items are indication for use, and materials. |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | Even though these are dimensional differences, the different sizes of two products<br>do not have any influences on the substantial equivalence, as the Indications<br>principles and the raw materials are equivalent. |

<Retainer Cap>

| | Subject Device | Predicate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K081575 |
| Device Name | CSM Submerged3-L<br>Implant System | O-Ring Retainer Cap set<br>(HU/HS/HG PROSTHETIC SYSTEM) |
| Manufacturer | CSM Implant | OSSTEM Implant |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | HU/HS/HG Prosthetic System is<br>intended for use with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns, bridges, or<br>overdentures. |
| Material | Ti-6A1-4V ELI (ASTM-F136) | Titanium / Silicone |
| Diameter | 5.45mm | 5.45mm |
| Length | 2.4mm | 2.35mm |
| Appearance | Image: Three stacked metal cylinders | Image: O-Ring Retainer Cap set |
| Principle Operation | Cap used to link overdenture to retainer<br>abutment. | Cap used to link overdenture to retainer<br>abutment. |
| Similarities | The main similarities of these two items are indications for use and how to function. | |
| Differences | Even though these are dimensional differences, the different sizes of two products<br>do not have any influences on the substantial equivalence, as the indications,<br>principles, and the raw materials are equivalent. | |

<Retainer Retention Male>

| | Subject Device | Predicate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K173141 | K112787 |
| Device Name | CSM Submerged3-L<br>Implant System | Kerator |
| Manufacturer | CSM Implant | KJ Meditech Co, Ltd. |
| Indications for Use | The CSM Submerged3-L Implant<br>System is intended for use in support of<br>single or multiple-unit restorations and<br>partial or fully edentulous mandibles and<br>maxilla. This system is intended for<br>delayed loading. | The Kerator is appropriate for use with<br>overdentures or partial dentures retained<br>in whole or in part by endosseous<br>implants in the mandible or maxilla. |
| Material | POLYAMIDE 6.6 | DuPont Zytel 101L NC-10 Nylon Low<br>Density Polyethelene 993 |
| Diameter | 4.7mm | 4.8mm |
| Length | 1.85mm, 2.06mm | 1.48mm |
| Appearance | Image: white ring | Image: yellow ring |

{11}------------------------------------------------

| Patient contact | No | No |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------…