(216 days)
No
The summary does not mention AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and performance studies focus on the physical components, materials, and standard mechanical and biological testing.
Yes
This device is a dental implant system used in support of dental restorations, which addresses a health condition (edentulism) by replacing missing teeth. This functional replacement constitutes a therapeutic purpose.
No
This device is a dental implant system used for supporting dental restorations, not for diagnosing medical conditions. Its function is to replace missing teeth, not to identify diseases or pathologies.
No
The device description explicitly lists physical components made of titanium and polyoxymethylene, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes things like blood tests, urine tests, and genetic tests.
- Device Description and Intended Use: The description clearly states that the Point implant system is a dental implant system used for supporting dental restorations in the mouth (mandibles and maxillae). It is a physical device implanted into the body.
- Lack of IVD Characteristics: The description does not mention any examination of specimens from the human body, diagnostic purposes, or laboratory testing.
Therefore, based on the provided information, the Point implant system is a medical device, specifically a dental implant system, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Point implant system consists of fixtures, mounts (and mount screws), abutments (cemented, angled, solid, temporary), abutment screws, healing abutments, and cover screws, as well as caps.
Fixtures (POF, POF Q, POF QNP) come in Mini, Regular, and Large sizes with varying diameters and lengths. They are made of Unalloyed Titanium (ASTM F67), are Internal Hex-connected Submerged Fixtures with tapered and straight body shapes. They undergo Gamma sterilization and have an S.L.A surface modification with a thread pitch of 0.8.
Mounts and Mount Screws are available in Mini and Regular sizes, with different diameters and lengths. Mounts are made of Alloyed Titanium (ASTM F136), and Mount Screws are also Alloyed Titanium (ASTM F136).
Abutments include:
- Cemented Abutment: Available in Mini and Regular sizes with various diameters and lengths. Made from Unalloyed Titanium (ASTM F67) and have Machine and TiN-Coating surface treatments. They are intended for end user sterilization.
- Angled Abutment (17°): Available in Mini and Regular sizes with differing diameters and lengths. Made from Unalloyed Titanium (ASTM F67) and have Machine and TiN-Coating surface treatments. They are intended for end user sterilization.
- Solid Abutment: Available in Mini and Regular sizes with various diameters and lengths. Made from Unalloyed Titanium (ASTM F67) and have Machine and TiN-Coating surface treatments. They are intended for end user sterilization.
- Temporary Abutment: Available in Mini and Regular sizes (Hex, Non-Hex) with different diameters and lengths. Made from Unalloyed Titanium (ASTM F67) and has a Machine surface treatment. They are intended for end user sterilization.
Healing Abutments come in Mini and Regular sizes with various diameters and lengths. They are made of Unalloyed Titanium (ASTM F67) and have a Machined surface. They undergo gamma sterilization.
Cover Screws are available in Mini and Regular sizes with different diameters and lengths. They are made of Unalloyed Titanium (ASTM F67) and have a Machine surface treatment. They undergo gamma sterilization.
Caps come in various diameters and lengths and are made of Polyoxymethylene (CAS No.: 30846-29-8). They are intended for end user sterilization.
The device is applied orally and has a contact duration of >30 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae
Indicated Patient Age Range
Dental prosthetic patients
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 Test Summary:
- Bio-compatibility: Tests performed according to ISO 10993-1, -3, -5, -6, -10, -11.
- Performance test:
- Fatigue Testing according to ISO 14801:2016 was performed on the subject device under the worst-case scenario and its result is strong enough to achieve their intended use.
- The Limulus amebocyte lysate (LAL) test according to the USP Bacteria Endotoxins Test is used for pyrogen limit.
- Surface modification information with SLA (Sandblasted Large grit and Acid-etched) surface treatment under the worst-case construction.
- Usability Evaluation Testing (ISO 11607-1:2019 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices.")
- Low and high magnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture jig).
- Quality System (QS) plan for packaging design.
- Validation:
- Gamma sterilization according to ISO 11137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6 accelerated aging study demonstrating a shelf life of 5 years for fixture, 8 years for healing abutment.
- The steam sterilization validation according to ANSI/AAMI ST79, ANSI/AAMI ST8, ISO 17665 ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6.
- MR Environment: MRI review performed for metallic devices using scientific rationale and published literature (Woods, Terry O., Jana G. Delfino, and Sunder Rajan."Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque."
Clinical Test Summary:
Clinical testing is not included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K153015, K161689, K182091, K192436
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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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.
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.
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.: | +82-51-363-3201 |
| Email Address: | changnamgu@pointnix.com |
| 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, | |||
| POF Q | |||
| 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 | |||
| 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 | |
| 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 | |||
| Abutment | Mini | 4.3 / 4.8 | 7.5 / 8.5 / 9.5 / 11.5 |
| Regular | 4.3 / 4.8 / 5.3 / | ||
| 6.3 / 7.3 | 8.5 / 9.5 / 10.5 / 12.5 | ||
| Angled | |||
| Abutment | |||
| (17°) | Mini | ||
| (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 | |||
| Abutment | Mini | 4.0 / 4.6 | 10.0 / 11.0 / 11.5 / 12.5 / 13.0 / 13.5 |
| 14.0 / 14.5 / 15.0 / 15.5 / 16.0 / 17.0 | |||
| Regular | 4.0 / 4.6 / | ||
| 5.0 / 6.0 | 10.4 / 11.4 / 11.9 / 12.4 / 12.9 / 13.4 | ||
| 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 | |||
| Abutment | Mini | ||
| (Hex, Non-Hex) | 4.0 | 13.9 / 15.9 | |
| Regular | |||
| (Hex, Non-Hex) | 4.5 | 13.7 / 15.7 | |
| Cap | None | 4.0 / 4.6 / 5.0 | |
| 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]
-
- 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 | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| Use | Point implant system is | ||
| indicated for use in | |||
| partially or fully or | |||
| edentulous mandibles | |||
| and maxillae, in support | |||
| of single or multiple units | |||
| restorations including; | |||
| cemented retained, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | The TS Fixture System is | ||
| indicated for use in partially | |||
| or fully edentulous | |||
| mandibles and maxillae, in | |||
| support of single or | |||
| multiple-unit restorations | |||
| including; cemented | |||
| retained, screw retained, or | |||
| overdenture restorations, | |||
| and final or temporary | |||
| abutment support for fixed | |||
| bridgework. It is intended | |||
| 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 | ||
| (ASTM F67) | Titanium Grade 4 | ||
| (ASTM F67) | Same | ||
| Connection | Internal Hex-connected | ||
| Submerged Fixture | |||
| Tapered body shape and | |||
| straight body shape | Internal Hex-connected | ||
| Submerged Fixture | |||
| Tapered body shape and | |||
| 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
| Proposed Device | Reference Device #2 | Note | |
|---|---|---|---|
| K Number | K222738 | K153015 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | same |
| Indications for | |||
| 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, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Transfer &Angled | ||
| Abutment is intended for | |||
| use with a dental implant | |||
| to provide support for | |||
| prosthetic restorations | |||
| such as crowns, bridges, | |||
| or over-dentures. | Similar | ||
| Design | Image: [abutment design 1]Image: [abutment design 2] | Image: [abutment design 3] | Similar |
9
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 | |||
| 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 | |||
| 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.
| Proposed Device | Reference Device#3 | Note | |
|---|---|---|---|
| K Number | K222738 | K161689 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| 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, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Rigid Abutment is | ||
| intended for use with a | |||
| dental implant to provide | |||
| support for prosthetic | |||
| restorations such as | |||
| crowns, bridges, or over- | |||
| dentures. | Similar | ||
| Design | Image: proposed device | Image: reference device | Similar |
| Composition of | |||
| 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 |
| abutment | |||
| Surface | |||
| 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. |
| Proposed Device | Reference Device #2 | Note | |
|---|---|---|---|
| K Number | K222738 | K153015 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| 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, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Transfer &Angled | ||
| Abutment is intended for | |||
| use with a dental implant | |||
| to provide support for | |||
| prosthetic restorations | |||
| such as crowns, bridges, | |||
| or over-dentures. | Similar | ||
| Design | Image: Proposed Device Design | Image: Reference Device #2 Design | Similar |
| Composition of | |||
| material | Titanium | Titanium | same |
| Diameters | 4.5, 5.0, 6.0mm | 4.0, 4.3, 4.5, 5.0, 5.5, 6.0 | |
| mm | Similar | ||
| Gingiva height | 2.0, 4.0mm | 2.0, 4.0mm | same |
| Angulation | 17° | 17° | Same |
| Surface | |||
| 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 | |||
| 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. |
| Proposed Device | Reference Device #4 | Note | |
|---|---|---|---|
| K Number | K222738 | K182091 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| 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, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Temporary Abutment is | ||
| intended for use with a | |||
| dental implant to provide | |||
| support for prosthetic | |||
| restorations such as | |||
| crowns, bridges, or over- | |||
| dentures. | Similar | ||
| Design | Image: Proposed Device Design | Image: Reference Device #4 Design | Similar |
| Composition of | |||
| material | Titanium | Titanium | Same |
| Diameters | 4.0, 4.5mm | 4.0, 4.5mm | Same |
| Gingiva height | 11, 13mm | 11, 13mm | Same |
| Angulation | - | - | Same |
| It is straight type | |||
| abutment | |||
| Surface | |||
| 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 | |||
| 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 | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Design | Image: Proposed Device Design | Image: Reference Device #3 Design | Similar |
| Composition of | |||
| material | Titanium Alloy | ||
| (ASTM F136) | Titanium Alloy | ||
| (ASTM F136) | Same | ||
| Diameters | 2.22, 2.33mm | 2.0, 2.05, 2.2, 2.3, | |
| 2.5mm | Similar | ||
| Length | 8.35, 10.2mm | 3.35, 5.6, 7.5, 8.35, 9.6, | |
| 10.2mm | Similar | ||
| Surface | |||
| 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.
| Proposed Device | Reference Device #3 | Note | |
|---|---|---|---|
| K Number | K222738 | K161689 | |
| Manufacturer | PointNix Co., Ltd. | OSSTEM Implant Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21CFR872.3640 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Design | Image: Proposed Device Design | Image: Reference Device #3 Design | Similar |
| Composition of | |||
| material | Polyoxumethylene | ||
| (CAS No. 30846-29-8) | Polycarbonate | ||
| (CAS No. 111211-39-3) | Different | ||
| Diameters | 4.0, 4.6, 5.0, 6.0, 7.0mm | 3.5mm | Different |
| Length | 5.8, 7.3, 8.8mm | 9.35, 9.75, 10.35 | Different |
13
Image /page/13/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, with segments in shades of blue, yellow, orange, and red. The text "PointNix" is written in a bold, sans-serif font, with a dark blue color. The logo is simple and modern, with a focus on color and typography.
B1 and 3F, 7, Hyoyeol-ro, Buk-gu, Busan, KOREA
| Proposed Device | Reference Device #3 | Note | |
|---|---|---|---|
| 10.75, 11.35, 11.75, | |||
| 12.35, 12.75, 13.35, | |||
| 13.75, 14.35, 14.75mm | |||
| Surface | |||
| treatment | - | - | Same |
| 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 are differences in the raw materials, the cap is contact temporarily for patients and is a commonly used safe material. Therefore, it is substantial equivalent.
| Proposed Device | Reference Device #5 | Note | |
|---|---|---|---|
| K Number | K222738 | K192436 | |
| Manufacturer | PointNix Co., Ltd. | Dentium Co., Ltd. | |
| Product Code | NHA | NHA | Same |
| Regulation | |||
| Number | 21CFR872.3640 | 21 CFR 872.3630 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| Use | Point implant system is | ||
| indicated for use in | |||
| partially or fully in | |||
| edentulous mandibles and | |||
| maxillae, in support of | |||
| single or multiple units | |||
| restorations including; | |||
| cemented retained, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Dentium prosthetics are | ||
| intended for use as an aid | |||
| prosthetic | |||
| in | |||
| rehabilitation. | Similar | ||
| Design | Image: proposed device design | Image: reference device design | Similar |
| Composition of | |||
| material | Titanium | Titanium | Same |
| Diameters | 4.3, 4.8, 5.3, 6.3, 7.3mm | 4.04, 4.1, 4.14, 4.2, 4.5, | |
| 4.54, 4.64, 4.7, 5.5, 5.54, | |||
| 5.64, 5.75, 6.5, 6.54, | |||
| 6.64, 6.75, 7.64, 8.64, | |||
| 9.64mm | Similar | ||
| Gingiva height | 8.5, 9.5, 10.5, 12.5mm | 8.7, 10.91, 10.93, 11.04, | |
| 11.15, 12.41, 12.44, | |||
| 12.55, 12.65, 12.66, | Similar |
14
Image /page/14/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
| Proposed Device | Reference Device #5 | Note | |
|---|---|---|---|
| 14.42, 14.44, 14.55, | |||
| 14.66mm | |||
| Angulation | - | - | |
| Surface treatment | Machined | Machine | Same |
| Sterilization | gamma sterilization | gamma 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. | |||
| Therefore, it is substantial equivalent. |
| Proposed Device | Reference Device #5 | Note | |
|---|---|---|---|
| K Number | K222738 | K192436 | |
| Manufacturer | PointNix Co., Ltd. | Dentium Co., Ltd. | Same |
| Product Code | NHA | NHA | |
| Regulation | |||
| Number | 21CFR872.3640 | 21 CFR 872.3630 | Same |
| 510(k) Review | |||
| Panel | Dental | Dental | Same |
| Indications for | |||
| 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, screw | |||
| retained, or overdenture | |||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed | |||
| bridgework. It is intended | |||
| for delayed loading. | Dentium prosthetics are | ||
| intended for use as an aid | |||
| in prosthetic | |||
| rehabilitation. | Similar | ||
| Design | Image: proposed device design | Image: reference device design | Similar |
| Composition of | |||
| material | Titanium | Titanium | Same |
| Diameters | 3.0, 3.1, 3.6mm | 3.1, 3.5mm | Similar |
| Length | 4.7, 5.2, 5.9mm | 4.7, 5.7mm | Similar |
| Surface | |||
| treatment | Machine | Machine | Same |
| Sterilization | gamma sterilization | gamma sterilization | Same |
| Substantial Equivalence Discussion | |||
| The diameter and length of proposed device is slightly different with predicate device. However, it |
15
.% PointNix
PointNix Co., Ltd.
B1 and 3F, 7, Hyoyeol-ro, Buk-qu, Busan, KOREA
| Proposed Device | Reference Device #5 | Note | |
|---|---|---|---|
| does not affect device's fundamental functions and safety. | |||
| Therefore, it is substantial equivalent. |
There are no significant differences between the point implant system and the predicate device that would be adversely affect the use of the product. It is substantially equivalent to these devices in indications for use, design, material, connection, surface treatment, thread pitch. It is similar but slight differences on dimensions with compared with predicate device. However, it does not affect device's fundamental functions and safety. And, although there are differences in the raw materials, the cap is contact temporarily for patients and is a commonly used safe material. In the case of Healing Abutment and Cover Screw, qamma sterilization has the same sterilization method as products of the same class, but our products are different from those of the same class in that steam sterilization) is also possible. But the safety was confirmed by verifying moist heat sterilization of the abutment that had undergone the same process with the same raw material.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The following data were provided in support of the substantial equivalence determination:
1) Bio-compatibility
Bio-compatibility test is performed according to below:
- . FDA Guidance document Use of International Standard ISO 10993-1, `Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- . ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin sensitization
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity .
2) Performance test
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance
Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".
- . Fatigue Testing according to ISO 14801:2016 was performed on the subject device under the worst-case scenario and its result is strong enough to achieve their intended use.
- . The proposed device will not be marketed as non-pyrogenic. During routine production, the method used to determine that the proposed sterile device meet the established pyrogen limit is the Limulus amebocyte lysate (LAL) test according to the USP Bacteria Endotoxins Test.
16
% PointNix
PointNix Co., Ltd.
B1 and 3F, 7, Hyoyeol-ro, Buk-qu, Busan, KOREA
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
The surface modification information with SLA (Sandblasted Large grit and Acid-etched) surface treatment under the worst-case construction.
Below performance testing and information have been provided for implant fixture packaging:
- . Usability Evaluation Testing (A usability evaluation for aseptic presentation of the subject device, in line with ISO 11607-1:2019 and the recommendations of the FDA quidance document, "Applying Human Factors and Usability Engineering to Medical Devices.")
- . Low and high maqnification images at various degrees of rotation following the removal from the packaging (Evaluation of the broken tip at various degrees rotation at a high magnification and low magnification for damage after removal from the packaging and disconnection of the fixture jig)
- Quality System (OS) plan including the method and frequency of acceptance activities to ensure that the devices conform with product specifications with packaging design.
3) Validation
[Gamma sterilization]
The gamma sterilization according to ISO 11137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6 accelerated aging study demonstrating a shelf life of 5 years for fixture, 8 years for healing abutment.
[User sterilization]
The steam sterilization validation according to ANSI/AAMI ST79, ANSI/AAMI ST8, ISO 17665 ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10-6.
4) MR Environment
MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan."Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque."
17
Image /page/17/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.
9. Clinical Test Summary [21 CFR 807.92(b)(2)]
Clinical testing is not included in this submission.
10.Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between proposed device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.
11.Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, concludes that the Point implant system is substantially equivalent in safety and effectiveness to the predicate device as described herein.