SNUCONE Bone Level Implant System
Device Facts
| Record ID | K210354 |
|---|---|
| Device Name | SNUCONE Bone Level Implant System |
| Applicant | Snucone Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jul 13, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
SNUCONE Bone Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or intermediate Abutment support for fixed bridge work. SNUCONE Bone Level Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Device Story
SNUCONE Bone Level Implant System consists of endosseous dental implants (fixtures), cover screws, abutments, and prosthetic components. Fixtures are surgically placed into the jawbone to support dental prostheses (crowns, bridges, dentures). System utilizes internal hex connection; fixtures are acid-etched titanium. Components include healing abutments, solo abutments, couple abutments (straight/angled), and temporary abutments. Used by dentists/oral surgeons in clinical settings. Device provides structural foundation for tooth replacement; restores chewing function. Benefits include improved oral function and aesthetics for edentulous patients.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing only, including mechanical fatigue testing (ISO 14801), SEM/EDS surface analysis, sterilization validation (ISO 17665, ISO 11737), shelf-life/packaging testing (ASTM F1980, F1140, F1929, F2096), biocompatibility (ISO 10993), bacterial endotoxin testing (ANSI/AAMI ST72), and MRI safety assessment based on scientific literature.
Technological Characteristics
Materials: Titanium Gr4 (ASTM F67) for fixtures; Ti 6Al-4V ELI (ASTM F136) for abutments/screws. Surface: Acid etching (fixtures), Anodizing (screws/some abutments). Connection: Internal Hex. Sterilization: Gamma irradiation. Dimensions: Fixture diameters Ø3.5-Ø6.8mm, lengths 7-14mm. Connectivity: Standalone mechanical system.
Indications for Use
Indicated for partially or fully edentulous patients (mandible/maxilla) requiring single or multiple-unit restorations, including cemented/overdenture restorations and fixed bridge support. Suitable for two-stage surgical procedures and immediate loading given good primary stability. Implants >5mm diameter indicated for molar regions.
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
- IS-III active System (K181138)
Reference Devices
- KONUS DENTAL IMPLANT SYSTEM (K141159)
- NUVO IF Implant System (K193234)
- AnyOne External Implant System (K203554)
Related Devices
- K202039 — Honorst Implant System · Medimecca Co., Ltd. · Sep 25, 2020
- K111003 — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL · Biodenta Swiss AG · Sep 15, 2011
- K182219 — SGS Dental Implants System · Sgs International, Ltd. · Aug 29, 2019
- K123512 — BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM · Biodenta Swiss AG · Mar 28, 2013
- K231426 — 8plant Implant System · Hoowon Edi Co., Ltd. · May 24, 2024
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
SNUCONE Co., LTD. % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seou 08503 KOREA, SOUTH
Re: K210354
Trade/Device Name: SNUCONE Bone Level Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 8, 2022 Received: June 10, 2022
## Dear Sanglok 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
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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 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,
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K210354
Device Name SNUCONE Bone Level Implant System
#### Indications for Use (Describe)
SNUCONE Bone Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or intermediate Abutment support for fixed bridge work. SNUCONE Bone Level Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
Type of Use (Select one or both, as applicable)
| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|X Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
# The assigned 510(k) Number: K210354
# 01. Date Prepared: July 12, 2022
## 02. Applicant
Company name: SNUCONE Co., LTD. Address: 5, Seongseo-ro 75-gil, Dalseo-gu, Daegu, Korea TEL: 82.53.592.7525 FAX: 82.53.592.7524 Email: snucone@naver.com
## 03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
## 04. Proposed Device Identification
Trade Name: SNUCONE Bone Level Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Primary Product Code: DZE Secondary Product Code: NHA Panel: Dental Regulation Number: 21 CFR 872.3640 Device Class: Class II
### 05. Indication for use
SNUCONE Bone Level Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations and terminal or intermediate Abutment support for fixed bridge work. SNUCONE Bone Level Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
## 06. Predicate and Reference Devices
Primary Predicate
- K181138, IS-III active System manufactured by NEOBIOTECH CO., LTD.
Reference devices
- K141159, KONUS DENTAL IMPLANT SYSTEM by Argon Med Productions & Vertriebs Gesellschaft mbH&Co.KG
- K193234, NUVO IF Implant System by JJGC Indústria e Comércio de Materiais Dentários S.A.
- K203554, AnyOne External Implant System by MegaGen Implant Co., Ltd.
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# 07. Device Description
SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw to support a dental prosthesis such as a crown, bridge, denture. Snucone's abutment and prosthetic components and tools are compatible with the Snucone's fixture only.
## 1) Fixtures and Cover Screw
There are 1 type of fixture and the dimensions and specification are as following:
| Product | AF+B |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Image: AF+B Implant |
| Platform Diameter | Ø3.5, Ø4.0, Ø4.3, Ø4.8, Ø5.3, Ø5.8, Ø6.3, Ø6.8 |
| Implant Length | Ø3.5: 7,8,9,10,11,12,13,14mm<br>Ø4.0: 7,8,9,10,11,12,13,14mm<br>Ø4.3: 7,8,9,10,11,12,13,14mm<br>Ø4.8: 7,8,9,10,11,12,13,14mm<br>Ø5.3: 7,8,9,10,11,12,13,14mm<br>Ø5.8: 7,8,9,10,11,12,13,14mm<br>Ø6.3: 7,8,9,10,11,12,13,14mm<br>Ø6.8: 7,8,9,10,11,12,13,14mm |
| Surface<br>Treatment | Acid etching |
| Implant-to-<br>Abutment<br>connection | Internal Hex |
| Material | Titanium Gr4 (ASTM F67) |
| Sterilization | Gamma irradiation |
| Shelf life | 5years |
| Product | Cover Screw |
| Appearance | Image: Cover Screws |
| Diameter | Ø3.3/Ø3.6 |
| Length | 5.3/6.6mm |
| Surface<br>Treatment | Anodizing |
| Material | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation |
| Shelf life | 5years |
Tolerance of dimension shall be within ± 1% range.
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# 2) Abutment and Component
## 2-1) Abutment
Dimensions and features of abutment are as following:
| Abutment | Abiding Healing Abutment | Abiding Solo Abutment | Abiding Couple Abutment | Abiding Couple Angled<br>Abutment |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Picture | Image: Abiding Healing Abutment | Image: Abiding Solo Abutment | Image: Abiding Couple Abutment | Image: Abiding Couple Angled Abutment |
| Use | This device is used to<br>connect with Fixture to<br>help gum tissue around the<br>implant site heal faster. | This device is a one-piece<br>abutment that is secured to<br>the Fixture without other<br>component. | This device is a two-piece<br>abutment that is secured to<br>the Fixture with an<br>abutment screw. | This device is a two-piece<br>abutment that is secured to<br>the Fixture with an<br>abutment screw. |
| Profile Diameter | Ø4.4 Ø4.9 Ø5.4 Ø5.9<br>Ø6.9 Ø7.9 Ø8.9 Ø9.9 | Ø4.0 Ø4.5 Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0<br>Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0<br>Ø5.5 Ø6.5 |
| Gingival Height | 1.0~5.5mm | 1.0~5.5mm | 1.0~7.5mm | 1.0~6.0mm |
| Post Height | 2.0/2.5/3.0 | 4.0/5.5/7.0 | 5.5/7.0 | 7.0 |
| Angle(°) | N/A | N/A | N/A | 15°, 25° |
| Anodizing | Pink, Blue | N/A | N/A | Yellow |
| Prosthetic<br>retention | - | Cement-retained | Cement-retained | Cement-retained |
| Restoration | - | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit |
| Material | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) |
| Sterilization | End-user sterilized | End-user sterilized | End-user sterilized | End-user sterilized |
| Shelf life | N/A | N/A | N/A | N/A |
| Abutment | Abiding Ti-Temporary<br>Abutment | Abiding Screw Abutment | | |
| Picture | Image: Abiding Ti-Temporary Abutment | Image: Abiding Screw Abutment | | |
| Use | This device is a two-piece<br>abutment that is<br>temporarily fixed to the<br>Fixture with an abutment<br>screw. This device is<br>intended to be used for a<br>maximum timeframe of 6<br>months. | This device is a one-piece<br>abutment and Abiding<br>Screw Abutment is always<br>to be used with the Ti-<br>Cylinder for single-unit<br>restorations. | | |
| Profile Diameter | Ø4.0 Ø4.5 | Ø4.9 | | |
| Gingival Height | 1.0mm | 1.0~4.0mm | | |
| Post Height | 10.0mm | - | | |
| Angle(°) | N/A | N/A | | |
| Anodizing | N/A | Yellow | | |
| Prosthetic<br>retention | Screw-retained | Screw-retained | | |
| Restoration | Single-unit<br>Multi-unit | Single-unit<br>Multi-unit | | |
| Material | Ti 6Al-4V ELI<br>(ASTM F136) | Ti 6Al-4V ELI<br>(ASTM F136) | | |
| Sterilization | End-user sterilized | End-user sterilized | | |
| Shelf life | N/A | N/A | | |
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Tolerance of dimension shall be within ± 1% range.
#### 2-2) Abutment Screw
Dimensions and features of abutment screw are as following:
| Abutment Screw | Abiding Retaining Screw | Abiding Abutment Screw |
|----------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Picture | | |
| Use | This product is a screw used to connect Abiding<br>screw Abutment to Screw Ti-cylinder. | This product is a screw used to connect both two-<br>piece Abutment to the Fixture |
| Size | D : Ø2.0, Ø2.05, Ø2.3 / L : 4.4~6.0mm | D : Ø2.2, Ø2.25 / L : 9.4~10.6mm |
| Material | Ti 6Al-4V ELI (ASTM F136) | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | End-user sterilized | End-user sterilized |
Tolerance of dimension shall be within ± 1% range.
## 2-3) Component - Cylinder
Dimensions and features of Ti-Cylinder are as following:
| Cylinder | Screw Abutment Ti-Cylinder |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Picture | Image: Screw Abutment Ti-Cylinder |
| Use | This product is a two-piece cylinder that is secured<br>to the Abiding Screw Abutment with retaining<br>screw. |
| Size | D: Ø4.9<br>L: 12.7mm |
| Minimum Post<br>Height | 4mm |
| Material | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | End-user sterilized |
Tolerance of dimension shall be within ± 1% range.
Fixture is packaged with Cover Screw, Abutment and Cylinder are packaged with single-packing or components, in some cases.
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# 08. Substantial Equivalence Comparison
1) Fixture
| Subject Device | Primary Predicate | | Reference device | | Design | Image: Implant | Image: Implant | Image: Implant | Image: Implant | Image: Implant | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | Argon Med Productions&Vertriebs<br>Gesellschaft mbH&Co.KG | JJGC Indústria e Comércio de<br>Materiais<br>Dentários S.A. | MegaGen Implant Co., Ltd. | Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex | External Hex |
| Device Name | AF+B Fixture<br>for SNUCONE Bone Level<br>Implant System | IS-III active System | K3Pro Konus Dental Implant<br>System | NUVO IF Implant System | AnyOne Esxternal Fixture | Diameters(Ø) | Ø3.5, Ø4.0, Ø4.3, Ø4.8,<br>Ø5.3, Ø5.8, Ø6.3, Ø6.8 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.0-6.0mm | 3.5mm, 3.75mm, 4.3mm, 5.0mm | Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm |
| 510(k) Number | K210354 | K181138 | K141159 | K193234 | K203554 | Lengths(mm) | Ø3.5: 7,8,9,10,11,12,13,14mm<br>Ø4.0: 7,8,9,10,11,12,13,14mm<br>Ø4.3: 7,8,9,10,11,12,13,14mm<br>Ø4.8: 7,8,9,10,11,12,13,14mm<br>Ø5.3: 7,8,9,10,11,12,13,14mm<br>Ø5.8: 7,8,9,10,11,12,13,14mm<br>Ø6.3: 7,8,9,10,11,12,13,14mm<br>Ø6.8: 7,8,9,10,11,12,13,14mm | 7.3/8.5/10.0/11.5/13.0/15.0 | 7.5-17mm | 3.5mm: 7,10,11.5,13,16,18mm<br>3.75mm: 7,10,11.5,13,16,18mm<br>4.3mm: 7,10,11.5,13,16,18mm<br>5.0mm: 7,10,11.5,13,16mm | Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm<br>Ø6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,<br>14.5mm |
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous,<br>Root-Form | Implant, Endosseous, Root-Form | Surface<br>Treatment | Acid etching | SLA | Acid etched | Sand blasted and acid etched | Sand-blasted, Large grit, Acid-<br>etched (SLA) |
| Product Code | DZE | DZE | DZE | DZE | DZE | Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Irradiation to an SAL of<br>$1 \times 10^{-6}$ | Gamma sterilization |
| Regulation<br>Number | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | Principle of<br>Operation | This product is a root-type fixture<br>which is inserted in the alveolar<br>bone. It replaces the functions of<br>the missing teeth as a dental<br>implant fixture. | This product is a root-type fixture<br>which is inserted in the alveolar<br>bone. It replaces the functions of<br>the missing teeth as a dental<br>implant fixture. | Unknown | Unknown | It is a tapered body fixture which is<br>inserted in the alveolar bone. It<br>replaces the functions of the<br>missing teeth as a dental implant<br>fixture, |
| Indications for<br>Use | SNUCONE Bone Level Implant<br>System is indicated for use in<br>partially or fully edentulous<br>mandibles and maxillae, in<br>support of single or multiple-unit<br>restorations including: cemented<br>retained, screw retained, or<br>overdenture restorations and<br>terminal or intermediate<br>Abutment support for fixed bridge<br>work. SNUCONE Bone Level<br>Implant System is dedicated for<br>two stage surgical procedures<br>and for immediate loading when<br>there is good primary stability and<br>an appropriate occlusal load.<br>Also, implants with diameters<br>larger than 5mm are indicated for<br>molar regions. | The IS-III active System is<br>indicated for use in partially or<br>fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations<br>including; cemented retained,<br>screw retained, or overdenture<br>restorations, and terminal or<br>intermediate Abutment support<br>for fixed bridgework. IS-III active<br>System is dedicated for two stage<br>surgical procedures and for<br>immediate loading when there is<br>good primary stability and an<br>appropriate occlusal load. Also,<br>implants with diameters larger<br>than 5mm are indicated for molar<br>regions. | The Konus K3Pro and K3Pro<br>Rapid Implant is designed for use<br>in edentulous sites in the mandible<br>or maxilla for support of a<br>complete denture prosthesis, a<br>terminal or intermediate abutment<br>for fixed bridgework or for partial<br>dentures, or as a single tooth<br>replacement. | The NUVO IF Implant System is<br>intended to be surgically placed in<br>the maxilla or mandible to provide<br>support for prosthetic devices such<br>as artificial teeth in order to restore<br>chewing function. It may be used<br>with single-stage or two-stage<br>procedures, for single or multiple<br>unit restorations, and may be<br>loaded immediately when good<br>primary stability is achieved and<br>with appropriate occlusal loading.<br>Multiple tooth applications may be<br>rigidly splinted.<br>The Titanium Temporary Abutment<br>is indicated to provide temporary<br>support for prosthesis structure for<br>up to 6 months.<br>The Attachment Equator and<br>Attachment Removable Prosthesis<br>abutments are indicated for the<br>attachment of full or partial<br>dentures to NUVO implants. | The AnyOne External Implant<br>System is intended to be surgically<br>placed in the maxillary or<br>mandibular molar areas for the<br>purpose providing prosthetic<br>support for dental restorations<br>(Crown, bridges, and<br>overdentures) in partially or fully<br>edentulous individuals. It is used to<br>restore a patient's chewing<br>function. Smaller implants (less<br>than 6.0mm) are dedicated for<br>immediate loading when good<br>primary stability is achieved and<br>with appropriate occlusal loading.<br>Larger implants are dedicated for<br>the molar region and are indicated<br>for delayed loading. | Similarities | SNUCONE Bone Level Implant System has the same device characteristics with the Primary predicates such as diameters, Length, intended use, material, principle of operation<br>connection design, design, structure, sterilization method- | | | | |
| Material | Titanium Gr4 (ASTM F67) | TI CP4 of ASTM F67 | Pure Titanium Grade 4 | Commercially Pure Titanium<br>(Grade 4) | CP Ti Grade 4<br>(ASTM F67-13) | Differences | K193234 was provided as a reference device for combinations of 3.5 diameters and 7mm lengths.<br>K203554 was provided as a reference device for combinations of diameter and lengths except for 3.5 diameters and 7mm lengths.<br>In addition, the surface treatment of the is acid etched method, while the primary predicate is SLA method. To support this inconsistency, K141159 is added as a reference device<br>to support the difference in surface treatment method. | | | | |
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1-2) Cover Screw
| | Subject Device | Primary Predicate |
|---------------|------------------------------------------------------|----------------------|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | Cover Screw<br>for SNUCONE Bone Level Implant System | IS-III active System |
| 510(k) Number | K210354 | K181138 |
{9}------------------------------------------------
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Image: blue and purple dental implant | Image: grey and yellow dental implant |
| Diameters(Ø) | Ø3.3 Ø3.6 | 3.45/3.6 |
| Lengths(mm) | 5.3/6.6mm | 5.85/6.85/7.45/ 6.4/7.4/8.0 |
| Anodizing | Anodizing | Anodizing/ Non-Anodizing, |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Principle of<br>Operation | It is used for protecting inner hole and connecting part with exposed upper part of<br>structure during the healing period after inserting dental implant fixture. When inserting<br>the Abutment, Cover screw is removed. | It is used for protecting inner hole and connecting part with exposed upper part of<br>structure during the healing period after inserting dental implant fixture. When inserting<br>the Abutment, Cover screw is removed. |
| Similarities | The Subject device and the primary predicate have the same material, anodizing characteristics, sterilization method, and principle of operation, and the diameter and length<br>are similar. | |
#### 2) Abutment, Abutment screw and Component
2-1) Abiding Healing Abutment
| | Subject Device | Primary Predicate |
|------------------------|---------------------------------…
