Point implant system

K222738 · Pointnix Co., Ltd. · DZE · Apr 13, 2023 · Dental

Device Facts

• Record ID: K222738
• Device Name: Point implant system
• Applicant: Pointnix Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Story

Point implant system consists of endosseous dental implants (fixtures) and associated abutments/screws. Fixtures are surgically placed into the mandible or maxilla to support prosthetic restorations. The system uses internal hex-connected, submerged fixtures with tapered or straight body shapes. Components are manufactured from unalloyed titanium (ASTM F67) or titanium alloy (ASTM F136), with a polyoxymethylene cap. The device is used by dental professionals in a clinical setting. The system is intended for delayed loading. Clinical benefit is provided through the support of prosthetic restorations in edentulous patients. The device is provided sterile (gamma) or requires user sterilization (steam).

Clinical Evidence

No clinical data included. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993 series), fatigue testing (ISO 14801), sterilization validation (ISO 11137, ISO 17665), and MRI safety assessment based on scientific literature.

Technological Characteristics

Endosseous dental implant system. Materials: Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), Polyoxymethylene. Surface: SLA (Sandblasted Large grit and Acid-etched). Connection: Internal Hex. Sterilization: Gamma or steam. Dimensions: Fixture diameters 3.75-6.7mm, lengths 7-13mm.

Indications for Use

Indicated for partially or fully edentulous mandibles and maxillae in dental prosthetic patients requiring single or multiple unit restorations (cemented, screw-retained, or overdenture) or fixed bridgework support. 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

• TS Fixture System (K121995)

Reference Devices

• Transfer & Angled Abutment (K153015)
• OSSTEM Implant System-Abutment (K161689)
• Osstem Abutment System (K182091)
• Healing Abutments and Cover Screw (K192436)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

PointNix Co., Ltd % BoKyeong Kim Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 REPUBLIC OF KOREA

Re: K222738

Trade/Device Name: Point implant system Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 17, 2023 Received: March 17, 2023

Dear BoKyeong 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222738

Device Name Point implant system

Indications for Use (Describe)

Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image contains the PointNix logo. The logo consists of a colorful graphic on the left and the company name "PointNix" in blue text on the right. The graphic is a stylized design with multiple colored segments, including yellow, orange, red, green, and blue.

# 510(k) Summary

[As Required by 21 CFR 807.92]

# 1. Date Prepared [21 CFR 807.92(a)(a)]

April 05, 2023

●

●

●

# 2. Submitter's Information [21 CFR 807.92(a)(1)]

| Name of Sponsor: | PointNix Co., Ltd |
|-----------------------|------------------------------------------------|
| Address: | B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA |
| Contact Name: | Chang Nam Lee / Manager |
| Telephone No.: | [phone] |
| Email Address: | [e-mail] |
| Name of Manufacturer: | PointNix Co., Ltd |
| Address: | B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA |

# 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| K no. | K222738 |
|-----------------------------|---------------------------|
| Product Name | Dental implant system |
| Model Name | Point implant system |
| Device Classification Name | Endosseous dental implant |
| Regulation Number | 872.3640 |
| Classification Product Code | DZE |
| Subsequent Product Code | NHA |
| Device Class | 2 |
| 510k Review Panel | Dental |

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Image /page/4/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful graphic to the left of the company name. The graphic is a stylized flower or starburst shape with petals or rays in different colors, including blue, green, yellow, and red. The company name "PointNix" is written in a bold, sans-serif font in blue.

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

### Predicate Device #1

- 510(k) Number: K121995
- Applicant: OSSTEM Implant Co., Ltd. ●
- Classification Name: Endosseous Dental Implant
- Proprietary Name: TS Fixture System
- Classification Product Code: DZE ●
- Regulation Number: 21 CFR 872.3630 ●

## Reference Device #2

- 510(k) Number: K153015
- Applicant: OSSTEM Implant Co., Ltd.
- Classification Name: Endosseous Dental Implant ●
- Proprietary Name: Transfer & Angled Abutment
- Classification Product Code: NHA ●
- Regulation Number: 21 CFR 872.3630 ●

## Reference Device #3

- 510(k) Number: K161689
- Applicant: OSSTEM Implant Co., Ltd.
- Classification Name: Endosseous Dental Implant
- Proprietary Name: OSSTEM Implant System-Abutment ●
- Classification Product Code: NHA ●
- Regulation Number: 21 CFR 872.3630

### Reference Device #4

- 510(k) Number: K182091
- Applicant: OSSTEM Implant Co., Ltd. ●
- Classification Name: Endosseous Dental Implant ●
- Proprietary Name: Osstem Abutment System
- Classification Product Code: NHA ●
- Regulation Number: 21 CFR 872.3630 ●

## Reference Device #5

- 510(k) Number: K192436
- Applicant: Dentium Co., Ltd.
- Classification Name: Endosseous Dental Implant ●
- Proprietary Name: Healing Abutments and Cover Screw ●
- . Classification Product Code: NHA

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Image /page/5/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful graphic to the left of the company name. The graphic is a stylized flower or burst of color, with petals or rays in yellow, orange, red, and blue. The company name, "PointNix," is written in a bold, dark blue font to the right of the graphic.

- . Regulation Number: 21 CFR 872.3630
The predicate device has not been subject to a design-related recall

# 5. Description of the Device [21 CFR 807.92(a)(4)]

#### 5.1. Overview

| No. | Item | Contents |
|-----|---------------------|----------------------------|
| 01 | Applied Part | Oral |
| 02 | Contact duration | C(>30days) |
| 03 | Patient populations | Dental prosthetic patients |

#### 5.2. Fixture Information

| | Type | Dia(mm) | Length(mm) |
|--------------------------|---------|--------------------|--------------------------------|
| POF,<br>POF Q<br>POF QNP | Mini | 3.75 | 8.5 / 10.0 / 11.5 / 13.0 |
| | Regular | 4.05 / 4.55 / 5.05 | 7.0 / 8.5 / 10.0 / 11.5 / 13.0 |
| | Regular | 6.0 / 6.7 | 7.0 / 8.5 / 9.5 / 11.0 / 12.5 |

Type is classified according to the packaging method.

- POF: Ampoule packing -
- -POF Q: Quartz packing
- POF QNP: Quartz pin packing -

#### 5.3. Mount & Mount Screw information

| | Type | Dia(mm) | Length(mm) |
|-------------|---------|---------|------------|
| Mount | Mini | 2.08 | 9.6 |
| | Regular | 2.48 | 10.1 |
| Mount Screw | Mini | 1.5 | 16.5 |
| | Regular | 1.8 | 15.6 |

#### Abutment / Abutment screw Information 5.4.

| Type | | Dia(mm) | Length(mm) |
|----------------------|---------|---------------------------------|---------------------------------------------------------------------------------------|
| Cemented<br>Abutment | Mini | 4.5 | 9.2 / 10.2 / 11.2 / 12.2 / 13.2 |
| | | 4.6 | 9.0 / 10.0 / 11.0 / 12.0 / 13.0 |
| | Regular | 5.0 / 6.0 | 7.5 / 8.5 / 9.0 / 9.5 / 10.0 / 10.5 / 11.0<br>11.5 / 12.0 / 12.5 / 13.0 / 13.5 / 14.5 |
| | 7.0 | 9.0 / 10.0 / 11.0 / 12.0 / 13.0 | |
| Abutment | Mini | 1.56 | 10.2 |

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Image /page/6/Picture/0 description: The image shows the PointNix logo. The logo consists of a colorful graphic to the left of the company name. The graphic is a burst of colors including blue, yellow, orange, and red.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| screw | Regular | 1.96 | 8.35 |
|-----------------------------|---------------------------|--------------------------------|-------------------------------------------------------------------------------------------|
| Healing<br>Abutment | Mini | 4.3 / 4.8 | 7.5 / 8.5 / 9.5 / 11.5 |
| | Regular | 4.3 / 4.8 / 5.3 /<br>6.3 / 7.3 | 8.5 / 9.5 / 10.5 / 12.5 |
| Angled<br>Abutment<br>(17°) | Mini<br>(A, B, Non-Hex) | 4.5 | 12.57 / 14.57 |
| | Regular | 5.0 | 12.47 / 14.47 |
| | Regular | 6.0 | 12.39 / 14.39 |
| Solid<br>Abutment | Mini | 4.0 / 4.6 | 10.0 / 11.0 / 11.5 / 12.5 / 13.0 / 13.5<br>14.0 / 14.5 / 15.0 / 15.5 / 16.0 / 17.0 |
| | Regular | 4.0 / 4.6 /<br>5.0 / 6.0 | 10.4 / 11.4 / 11.9 / 12.4 / 12.9 / 13.4<br>13.9 / 14.4 / 14.9 / 15.4 / 15.9 / 16.4 / 17.4 |
| | Regular | 7.0 | 11.9 / 12.9 / 13.9 / 14.9 / 15.9 |
| Cover screw | Mini | 3.1 | 4.7 |
| | Regular | 3.6 | 5.9 |
| Temporary<br>Abutment | Mini<br>(Hex, Non-Hex) | 4.0 | 13.9 / 15.9 |
| | Regular<br>(Hex, Non-Hex) | 4.5 | 13.7 / 15.7 |
| Cap | None | 4.0 / 4.6 / 5.0<br>6.0 / 7.0 | 5.3 / 7.3 / 8.8 |

#### 5.5. Material composition

| NO. | Model Name | Raw Material | Standard |
|-----|--------------------|--------------------|---------------------|
| 1 | Fixture | Unalloyed Titanium | ASTM F67 |
| 2 | Healing Abutment | Unalloyed Titanium | ASTM F67 |
| 3 | Cover Screw | Unalloyed Titanium | ASTM F67 |
| 4 | Mount | Alloyed Titanium | ASTM F136 |
| 5 | Mount screw | Alloyed Titanium | ASTM F136 |
| 6 | Cemented Abutment | Unalloyed Titanium | ASTM F67 |
| 7 | Abutment Screw | Alloyed Titanium | ASTM F136 |
| 8 | Angled Abutment | Unalloyed Titanium | ASTM F67 |
| 9 | Solid Abutment | Unalloyed Titanium | ASTM F67 |
| 10 | Temporary Abutment | Unalloyed Titanium | ASTM F67 |
| 11 | Cap | Polyoxymethylene | CAS No.: 30846-29-8 |

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Image /page/7/Picture/0 description: The image features the logo for PointNix. To the left of the company name is a colorful graphic that resembles a flower or starburst. The colors in the graphic include blue, yellow, orange, and red. The company name, "PointNix", is written in a bold, blue font.

# 6. Indications for Use [21 CFR 807.92(a)(5)]

Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

# 7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

There are no significant differences in the technological characteristics of these devices compared to the predicate device which adversely affect safety or effectiveness. A table comparing the key features of the subject device and the predicate device is provided below table.

# [Table. Comparison of Proposed Device to Predicate Device]

- 1) Fixture

| | Proposed Device | Predicate Device #1 | Note |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K222738 | K121995 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | DZE | DZE | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Indications for<br>Use | Point implant system is<br>indicated for use in<br>partially or fully or<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple units<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | The TS Fixture System is<br>indicated for use in partially<br>or fully edentulous<br>mandibles and maxillae, in<br>support of single or<br>multiple-unit restorations<br>including; cemented<br>retained, screw retained, or<br>overdenture restorations,<br>and final or temporary<br>abutment support for fixed<br>bridgework. It is intended<br>for delayed loading. | Same |
| Design | Image: Implant design | Image: Implant design | Similar |

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Image /page/8/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful graphic to the left of the company name. The graphic is a burst of colors including blue, yellow, orange, and red. The company name "PointNix" is written in a bold, blue font.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| | Proposed Device | Predicate Device #1 | Note |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------|
| Composition of material | Titanium Grade 4<br>(ASTM F67) | Titanium Grade 4<br>(ASTM F67) | Same |
| Connection | Internal Hex-connected<br>Submerged Fixture<br>Tapered body shape and<br>straight body shape | Internal Hex-connected<br>Submerged Fixture<br>Tapered body shape and<br>straight body shape | Same |
| Platform diameters | 3.75~6.7mm | 3.75~6.8mm | Similar |
| Fixture diameter | 3.75~6.7mm | 3.75~6.8mm | Similar |
| Length | 7~13mm | 7~15mm | Similar |
| Sterilization | Gamma sterilization | Gamma sterilization | Same |
| Modified surface | S.L.A | S.L.A | Same |
| Thread pitch | 0.8 | 0.8 | Same |
| Substantial Equivalence Discussion | | | |
| The diameter and length of proposed device is slightly different with predicate device. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | | |

# 2) Abutment

<cemented abutment>

| | Proposed Device | Reference Device #2 | Note |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K222738 | K153015 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | same |
| Indications for<br>Use | Point implant system is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple units<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | Transfer &Angled<br>Abutment is intended for<br>use with a dental implant<br>to provide support for<br>prosthetic restorations<br>such as crowns, bridges,<br>or over-dentures. | Similar |
| Design | Image: [abutment design 1]Image: [abutment design 2] | Image: [abutment design 3] | Similar |

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Image /page/9/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful, stylized flower-like graphic to the left of the company name. The name "PointNix" is written in a bold, blue font.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| | Proposed Device | Reference Device #2 | Note |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------|----------------------|
| Composition of<br>material | Titanium | Titanium | Same |
| Diameters | 4.0, 4.6, 5.0, 6.0, 7.0mm | 4.0 4.6, 5.0, 6.0, 7.0 mm | Same |
| Gingiva height | 1.0, 2.0, 3.0, 4.0, 5.0mm | 1.0, 2.0, 3.0, 4.0, 5.0mm | Same |
| Angulation | - | - | It is straight type. |
| Surface<br>treatment | Machine, TiN-Coating | TiN-Coating | Similar |
| Sterilization | End user sterilization | End user sterilization | Same |
| Substantial Equivalence Discussion | | | |
| The diameter and length of proposed device is slightly different with predicate device. However, it does not affect device's fundamental functions and safety. Although there is a difference in surface treatment, biocompatibility tests were performed for our device, and there was no safety problem. | | | |

Therefore, it is substantial equivalent.

<solid abutment>

| | Proposed Device | Reference Device#3 | Note |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K222738 | K161689 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Indications for<br>Use | Point implant system is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple units<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | Rigid Abutment is<br>intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or over-<br>dentures. | Similar |
| Design | Image: proposed device | Image: reference device | Similar |
| Composition of<br>material | Titanium | Titanium | Same |
| Diameters | 4.0, 4.6, 5.0, 6.0, 7.0mm | 4.0, 4.6, 5.0, 6.0, 7.0mm | Same |
| Gingiva height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.0, 2.0, 3.0, 4.0, 5.0mm | Similar |

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

Image /page/10/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful graphic to the left of the company name. The graphic is a stylized flower or burst of color, with petals or segments in orange, yellow, green, blue, and red. The company name "PointNix" is written in a bold, blue sans-serif font to the right of the graphic.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| | Proposed Device | Reference Device#3 | Note |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|---------------------------------|
| Angulation | - | - | It is straight type<br>abutment |
| Surface<br>treatment | Machine, TiN-Coating | TiN-Coating | Similar |
| Sterilization | End user sterilization | End user sterilization | Same |
| <b>Substantial Equivalence Discussion</b><br>The diameter and length of proposed device is slightly different with predicate device. However, it does not affect device's fundamental functions and safety. Although there is a difference in surface treatment, biocompatibility tests were performed for our device, and there was no safety problem. Therefore, it is substantial equivalent. | | | |

<angled abutment>

| | Proposed Device | Reference Device #2 | Note |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| K Number | K222738 | K153015 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Indications for<br>Use | Point implant system is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple units<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | Transfer &Angled<br>Abutment is intended for<br>use with a dental implant<br>to provide support for<br>prosthetic restorations<br>such as crowns, bridges,<br>or over-dentures. | Similar |
| Design | Image: Proposed Device Design | Image: Reference Device #2 Design | Similar |
| Composition of<br>material | Titanium | Titanium | same |
| Diameters | 4.5, 5.0, 6.0mm | 4.0, 4.3, 4.5, 5.0, 5.5, 6.0<br>mm | Similar |
| Gingiva height | 2.0, 4.0mm | 2.0, 4.0mm | same |
| Angulation | 17° | 17° | Same |
| Surface<br>treatment | Machine, TiN-Coating | TiN-Coating | Similar |
| Sterilization | End user sterilization | End user sterilization | Same |
| Substantial Equivalence Discussion | | | |

510(k) Summary

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

Image /page/11/Picture/0 description: The image shows the logo for PointNix. The logo consists of a colorful graphic to the left of the company name. The graphic is a stylized flower or starburst shape with petals or rays in blue, yellow, orange, and red. The company name "PointNix" is written in a bold, blue sans-serif font to the right of the graphic.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| | Proposed Device | Reference Device #2 | Note |
|--|-----------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | The diameter and length of proposed device is slightly different with predicate device. However, it<br>does not affect device's fundamental functions and safety. Although there is a difference in surface<br>treatment, biocompatibility tests were performed for our device, and there was no safety problem.<br>Therefore, it is substantial equivalent. |

### <temporary abutment>

| | Proposed Device | Reference Device #4 | Note |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| K Number | K222738 | K182091 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Indications for<br>Use | Point implant system is<br>indicated for use in<br>partially or fully<br>edentulous mandibles and<br>maxillae, in support of<br>single or multiple units<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and final or<br>temporary abutment<br>support for fixed<br>bridgework. It is intended<br>for delayed loading. | Temporary Abutment is<br>intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as<br>crowns, bridges, or over-<br>dentures. | Similar |
| Design | Image: Proposed Device Design | Image: Reference Device #4 Design | Similar |
| Composition of<br>material | Titanium | Titanium | Same |
| Diameters | 4.0, 4.5mm | 4.0, 4.5mm | Same |
| Gingiva height | 11, 13mm | 11, 13mm | Same |
| Angulation | - | - | Same<br>It is straight type<br>abutment |
| Surface<br>treatment | Machine | Machine | Similar |
| Sterilization | End user sterilization | End user sterilization | Same |
| Substantial Equivalence Discussion | | | |
| The diameter and length of proposed device is slightly different with predicate device. However, it<br>does not affect device's fundamental functions and safety. Although there is a difference in surface | | | |

treatment, biocompatibility tests were performed for our device, and there was no safety problem. Therefore, it is substantial equivalent.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image contains the logo for PointNix. The logo consists of a colorful abstract flower-like graphic on the left, with petals in blue, green, yellow, orange, and red. To the right of the graphic is the company name "PointNix" in a bold, blue sans-serif font.

B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA

| | Proposed Device | Reference Device #3 | Note |
|-----------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------|-----------|
| K Number | K222738 | K161689 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Design | Image: Proposed Device Design | Image: Reference Device #3 Design | Similar |
| Composition of<br>material | Titanium Alloy<br>(ASTM F136) | Titanium Alloy<br>(ASTM F136) | Same |
| Diameters | 2.22, 2.33mm | 2.0, 2.05, 2.2, 2.3,<br>2.5mm | Similar |
| Length | 8.35, 10.2mm | 3.35, 5.6, 7.5, 8.35, 9.6,<br>10.2mm | Similar |
| Surface<br>treatment | Machine | WC Coating | Different |
| Sterilization | End user sterilization | End user sterilization | Same |
| Substantial Equivalence Discussion | | | |
| The diameter and length of proposed device is slightly different with predicate device. However, it | | | |
| does not affect device's fundamental functions and safety. | | | |

ough there is a difference in surface treatment, Our device does not have surface coating. નાના Although there is a difference in Surfall Therefore, it is substantial equivalent.

# <Cap>

| | Proposed Device | Reference Device #3 | Note |
|----------------------------|------------------------------------------|----------------------------------------|-----------|
| K Number | K222738 | K161689 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation<br>Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review<br>Panel | Dental | Dental | Same |
| Design…