(520 days)
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.
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.
This document describes the SNUCONE Bone Level Implant System, a dental implant system. The information provided outlines the device, its components, and a comparison to predicate devices for substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study would. Instead, it focuses on bench testing and adherence to recognized standards.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical tests and the standards they adhere to. However, it does not provide a table with specific quantitative acceptance criteria for each test and the numerical reported performance of the device against those criteria. It generally states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
Here's a summary of the tests and the general statement of performance:
| Test/Criteria Category | Acceptance Criteria (from standards) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Fatigue testing (Abutments) | According to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and "ISO 14801:2016 Dentistry -Fatigue test for endosseous dental implants" | Met the criteria of the standards |
| SEM/EDS analysis (Surface treatment media removal) | According to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | Confirmed removal of surface treatment media and met the criteria of the standards |
| Sterilization, Shelf-life and Packaging | ||
| End User Sterilization Validation | According to ISO 17665-1:2006, ISO 17665-2:2009, ISO 11737-1:2006, and ISO 11737-2:2009 | Met the criteria of the standards |
| Gamma Sterilization Validation | According to ISO 11737-1:2006, and ISO 11737-2:2009 | Met the criteria of the standards |
| Accelerated Aging Test (Shelf-life) | According to ASTM F1980-16, ASTM F1140-13, ASTM F1929-15, and ASTM F2096-11 | Met the criteria of the standards |
| MR Environment Condition | ||
| Magnetically induced displacement force and torque | Parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and published literature (Woods et al. 2019) | Met the criteria based on scientific rationale and literature review |
| Bacterial Endotoxin | ||
| Endotoxin levels | According to ANSI/AAMI ST72:2019 | Met the criteria of the standards |
| Biocompatibility | ||
| Biocompatibility evaluation | According to ISO 10993 | Met the criteria of the standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the non-clinical bench tests (e.g., number of implants tested for fatigue). It refers to standards like ISO 14801 which would dictate sample sizes, but the numerical value is not explicitly stated.
- Data Provenance (Country of Origin, Retrospective/Prospective): The document does not provide details on the country of origin of the data or whether the data was retrospective or prospective. Given that these are non-clinical bench tests, the concept of "retrospective" or "prospective" as applied to clinical studies is not directly applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The document describes non-clinical bench testing of a dental implant system, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" here refers to the physical and chemical properties and performance characteristics determined by the test methods outlined in the specified standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus, which is not the nature of the tests described in this document. The results of the mechanical, sterilization, MRI, endotoxin, and biocompatibility tests are determined by adherence to established, objective engineering and scientific standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This document describes a dental implant system, not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical dental implant system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests described is defined by the objective, measurable criteria within the referenced international and national standards (e.g., ISO 14801, ISO 17665, ASTM F1980, ANSI/AAMI ST72, ISO 10993). For example:
- Fatigue testing: The "ground truth" is whether the implant withstands a specified number of cycles at a certain load without failure, as defined by ISO 14801.
- Sterilization validation: The "ground truth" is achieving the required sterility assurance level (SAL), as defined by ISO 11737.
- Biocompatibility: The "ground truth" is that the material does not elicit adverse biological responses, as assessed by the tests specified in ISO 10993.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for the reasons stated above.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
|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: 7,8,9,10,11,12,13,14mmØ4.0: 7,8,9,10,11,12,13,14mmØ4.3: 7,8,9,10,11,12,13,14mmØ4.8: 7,8,9,10,11,12,13,14mmØ5.3: 7,8,9,10,11,12,13,14mmØ5.8: 7,8,9,10,11,12,13,14mmØ6.3: 7,8,9,10,11,12,13,14mmØ6.8: 7,8,9,10,11,12,13,14mm |
| SurfaceTreatment | Acid etching |
| Implant-to-Abutmentconnection | 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 |
| SurfaceTreatment | 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 AngledAbutment |
|---|---|---|---|---|
| Picture | Image: Abiding Healing Abutment | Image: Abiding Solo Abutment | Image: Abiding Couple Abutment | Image: Abiding Couple Angled Abutment |
| Use | This device is used toconnect with Fixture tohelp gum tissue around theimplant site heal faster. | This device is a one-pieceabutment that is secured tothe Fixture without othercomponent. | This device is a two-pieceabutment that is secured tothe Fixture with anabutment screw. | This device is a two-pieceabutment that is secured tothe Fixture with anabutment screw. |
| Profile Diameter | Ø4.4 Ø4.9 Ø5.4 Ø5.9Ø6.9 Ø7.9 Ø8.9 Ø9.9 | Ø4.0 Ø4.5 Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0Ø5.5 Ø6.5 | Ø4.0 Ø4.5 Ø5.0Ø5.5 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 |
| Prostheticretention | - | Cement-retained | Cement-retained | Cement-retained |
| Restoration | - | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit |
| Material | Ti 6Al-4V ELI(ASTM F136) | Ti 6Al-4V ELI(ASTM F136) | Ti 6Al-4V ELI(ASTM F136) | Ti 6Al-4V ELI(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-TemporaryAbutment | Abiding Screw Abutment | ||
| Picture | Image: Abiding Ti-Temporary Abutment | Image: Abiding Screw Abutment | ||
| Use | This device is a two-pieceabutment that istemporarily fixed to theFixture with an abutmentscrew. This device isintended to be used for amaximum timeframe of 6months. | This device is a one-pieceabutment and AbidingScrew Abutment is alwaysto be used with the Ti-Cylinder for single-unitrestorations. | ||
| 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 | ||
| Prostheticretention | Screw-retained | Screw-retained | ||
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | ||
| Material | Ti 6Al-4V ELI(ASTM F136) | Ti 6Al-4V ELI(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 Abidingscrew Abutment to Screw Ti-cylinder. | This product is a screw used to connect both two-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 securedto the Abiding Screw Abutment with retainingscrew. |
| Size | D: Ø4.9L: 12.7mm |
| Minimum PostHeight | 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
- 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&VertriebsGesellschaft mbH&Co.KG | JJGC Indústria e Comércio deMateriaisDentários S.A. | MegaGen Implant Co., Ltd. | Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex | External Hex |
| Device Name | AF+B Fixturefor SNUCONE Bone LevelImplant System | IS-III active System | K3Pro Konus Dental ImplantSystem | NUVO IF Implant System | AnyOne Esxternal Fixture | Diameters(Ø) | Ø3.5, Ø4.0, Ø4.3, Ø4.8,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, 12.5,14.5mmØ4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mm |
| 510(k) Number | K210354 | K181138 | K141159 | K193234 | K203554 | Lengths(mm) | Ø3.5: 7,8,9,10,11,12,13,14mmØ4.0: 7,8,9,10,11,12,13,14mmØ4.3: 7,8,9,10,11,12,13,14mmØ4.8: 7,8,9,10,11,12,13,14mmØ5.3: 7,8,9,10,11,12,13,14mmØ5.8: 7,8,9,10,11,12,13,14mmØ6.3: 7,8,9,10,11,12,13,14mmØ6.8: 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: 7,10,11.5,13,16,18mm3.75mm: 7,10,11.5,13,16,18mm4.3mm: 7,10,11.5,13,16,18mm5.0mm: 7,10,11.5,13,16mm | Ø3.9 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ4.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ4.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ5.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ5.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ6.3 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mmØ6.8 x 7.0, 8.0, 9.5, 11.0, 12.5,14.5mm |
| DeviceClassificationName | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous,Root-Form | Implant, Endosseous, Root-Form | SurfaceTreatment | Acid etching | SLA | Acid etched | Sand blasted and acid etched | Sand-blasted, Large grit, Acid-etched (SLA) |
| Product Code | DZE | DZE | DZE | DZE | DZE | Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization | Gamma Irradiation to an SAL of$1 \times 10^{-6}$ | Gamma sterilization |
| RegulationNumber | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | Principle ofOperation | This product is a root-type fixturewhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. | This product is a root-type fixturewhich is inserted in the alveolarbone. It replaces the functions ofthe missing teeth as a dentalimplant fixture. | Unknown | Unknown | It is a tapered body fixture which isinserted in the alveolar bone. Itreplaces the functions of themissing teeth as a dental implantfixture, |
| Indications forUse | SNUCONE Bone Level ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unitrestorations including: cementedretained, screw retained, oroverdenture restorations andterminal or intermediateAbutment support for fixed bridgework. SNUCONE Bone LevelImplant System is dedicated fortwo stage surgical proceduresand for immediate loading whenthere is good primary stability andan appropriate occlusal load.Also, implants with diameterslarger than 5mm are indicated formolar regions. | The IS-III active System isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and terminal orintermediate Abutment supportfor fixed bridgework. IS-III activeSystem is dedicated for two stagesurgical procedures and forimmediate loading when there isgood primary stability and anappropriate occlusal load. Also,implants with diameters largerthan 5mm are indicated for molarregions. | The Konus K3Pro and K3ProRapid Implant is designed for usein edentulous sites in the mandibleor maxilla for support of acomplete denture prosthesis, aterminal or intermediate abutmentfor fixed bridgework or for partialdentures, or as a single toothreplacement. | The NUVO IF Implant System isintended to be surgically placed inthe maxilla or mandible to providesupport for prosthetic devices suchas artificial teeth in order to restorechewing function. It may be usedwith single-stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusal loading.Multiple tooth applications may berigidly splinted.The Titanium Temporary Abutmentis indicated to provide temporarysupport for prosthesis structure forup to 6 months.The Attachment Equator andAttachment Removable Prosthesisabutments are indicated for theattachment of full or partialdentures to NUVO implants. | The AnyOne External ImplantSystem is intended to be surgicallyplaced in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations(Crown, bridges, andoverdentures) in partially or fullyedentulous individuals. It is used torestore a patient's chewingfunction. Smaller implants (lessthan 6.0mm) are dedicated forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Larger implants are dedicated forthe molar region and are indicatedfor 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 operationconnection design, design, structure, sterilization method- | ||||
| Material | Titanium Gr4 (ASTM F67) | TI CP4 of ASTM F67 | Pure Titanium Grade 4 | Commercially Pure Titanium(Grade 4) | CP Ti Grade 4(ASTM F67-13) | Differences | K193234 was provided as a reference device for combinations of 3.5 diameters and 7mm lengths.K203554 was provided as a reference device for combinations of diameter and lengths except for 3.5 diameters and 7mm lengths.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 deviceto 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 Screwfor SNUCONE Bone Level Implant System | IS-III active System |
| 510(k) Number | K210354 | K181138 |
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| 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 ofOperation | It is used for protecting inner hole and connecting part with exposed upper part ofstructure during the healing period after inserting dental implant fixture. When insertingthe Abutment, Cover screw is removed. | It is used for protecting inner hole and connecting part with exposed upper part ofstructure during the healing period after inserting dental implant fixture. When insertingthe 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 lengthare similar. |
2) Abutment, Abutment screw and Component
2-1) Abiding Healing Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd. |
| Device Name | Abiding Healing Abutmentfor SNUCONE Bone Level Implant System | IS-III active System |
| 510(k) Number | K210354 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: purple and blue abutment | Image: silver abutment |
| Diameters( $Ø$ ) | $Ø$ 4.4 $Ø$ 4.9 $Ø$ 5.4 $Ø$ 5.9$Ø$ 6.9 $Ø$ 7.9 $Ø$ 8.9 $Ø$ 9.9 | 4.0/4.5/4.8/5.5/6.0/6.8/8.0/9.0 |
| GingivalHeight(mm) | 1.0~5.5mm | 2.3/2.8/3.3/3.8/4.3/4.8/5.3/5.8/6.3/6.8/7.8 |
| Anodizing | Anodizing | N/A |
| Sterilization | Non-Sterilization | Gamma irradiation |
| Principle of | This product is healing Abutment to formation appropriate gingival shape during the | This product is healing Abutment to formation appropriate gingival shape during the |
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| Operation | soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. | soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. |
|---|---|---|
| Similarities | The subject device has the same principle of operation, material, design and similar diameter and length as the reference device. |
2-2) Abiding Solo Abutment
| Subject Device | Reference device | |
|---|---|---|
| Company | SNUCONE Co., LTD. | JJGC Indústria e Comércio de MateriaisDentários S.A. |
| Device Name | Abiding Solo Abutmentfor SNUCONE Bone Level Implant System | NUVO IF Implant System |
| 510(k) Number | K210354 | K193234 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Titanium Alloy (Ti-6Al-4V) |
| Design | Image: Abiding Solo Abutment | Image: NUVO IF Implant System |
| Diameters(Ø) | Ø4.0 Ø4.5 Ø5.5 Ø6.5 | Platform Ø3.5(NP) Ø4.5(SP) |
| GingivalHeight(mm) | 1.0~5.5mm | 0.5, 1.2, 1.5, 3mm |
| SurfaceTreatment | N/A | Machined and anodized (only NP platform) |
| Principle ofOperation | This Product is one-piece cement retained restoration, connected with fixture andcemented crown on the Abutment. | Abutment designed to accept a cement-retained prosthetic. |
| Similarities | The subject device and reference device have the similar technological characteristic, and are made of same materials. The subject device and reference device have similarphysical dimensions, including diameter and lengths. Therefore, the subject device is substantially equivalent to the currently reference devices. |
2-3) Abiding Couple / Abiding Couple Angled Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | Abiding Couple, Couple Angled Abutmentfor SNUCONE Implant System | IS-III active System |
| 510(k) Number | K210354 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
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| Design | |||||||
|---|---|---|---|---|---|---|---|
| Hex | Non-Hex | Hex | Non-Hex | SCRP | |||
| Diameters(Ø) | Ø4.0 Ø4.5 Ø5.5 Ø6.5 | 4.5/5.2/5.7/6.5 | |||||
| GingivalHeight(mm) | 1.0~7.5mm | 1,2,3,4,5mm | |||||
| Anodizing | Non-Anodizing | Non-Anodizing | |||||
| Abiding Couple Angled Abutment | |||||||
| Design | |||||||
| Hex, Non-Hex | Hex, Non-Hex | Hex | Non-Hex | ||||
| Diameters(Ø) | Ø4.0 Ø4.5 Ø5.0 Ø5.5 Ø6.5 | 4.5/5.2/5.7 | |||||
| GingivalHeight(mm) | 1.0~6.0mm | 2,3,4mm | |||||
| Angle (°) | 15°, 25° | 15/25 | |||||
| Anodizing | Non-Anodizing, Anodizing | Non-Anodizing | |||||
| Principle ofOperation | This product is two-piece abutment that is indicated for screw-retained single tooth orcement retained single tooth and bridge restorations. | It is indicated for screw-retained single tooth or cement retained single tooth and bridgerestorations. | |||||
| Similarities | They are substantially equivalent in material, design, dimension, connection, functions. Subject device is similar in fundamental scientific technology to the primary predicate inthat they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants andendosseous dental implant abutments. |
2-4) Abiding Ti-Temporary Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | Abiding Ti-Temporary Abutmentfor SNUCONE Implant System | IS-III active System |
| 510(k) Number | K210354 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
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| Design | ||||
|---|---|---|---|---|
| Hex | Non-Hex | Hex | Non-Hex | |
| Diameters(Ø) | Ø4.0 Ø4.5 | 4.5 | ||
| Gingival | 1.0mm | 6.0/8.0/11.5 | ||
| Height(mm) | ||||
| Principle ofOperation | It is dental Abutments designed to serve as a temporary dental prosthesis during thehealing process until a permanent crown is made. | It is dental Abutments designed to serve as a temporary dental prosthesis during thehealing process until a permanent crown is made. | ||
| Maximumtimeframe foruse | ≤ 6 month | Expected to be less than 6 month | ||
| Similarities | The subject device and primary predicate are substantially equivalent material, connection type, design, principle of operation, and maximum timeframe for use. |
2-5) Abiding Screw Abutment
| Subject Device | Reference device | |
|---|---|---|
| Company | SNUCONE Co., LTD. | JJGC Indústria e Comércio de MateriaisDentários S.A. |
| Device Name | Abiding Screw Abutmentfor SNUCONE Implant System | NUVO IF Implant System |
| 510(k) Number | K210354 | K193234 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Titanium Alloy (Ti-6Al-4V) |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters(Ø) | Ø4.9 | Platform Ø3.5&4.8mm (NP), Ø4.8mm (SP) |
| GingivalHeight(mm) | 1.0~4.0mm | NP – 0.5/1/2/2.3/3/4/5mmSP – 1/2/2.3/3/4/5mm |
| Angle (°) | 0° | 0°, 17°, 30° |
| Anodizing | Non-Anodizing, Anodizing | Machined and anodized (only NP platform) |
| Similarities | The subject device and the reference device have same raw materials and designs, and have similar physical sizes such as diameter and height. Therefore, the subject deviceand reference device are practically the similar. |
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2-6) Abutment Screw
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | |
| Device Name | Abiding Retaining Screw | Abiding Abutment Screw | IS-III active System |
| 510(k) Number | K210354 | K210354 | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Abiding Retaining Screw | Image: Abiding Abutment Screw | Image: IS-III active System |
| Diameters(Ø) | Ø2.0, Ø2.05, Ø2.3 | Ø2.2, Ø2.25 | 2.3 |
| Lengths(mm) | 4.4~6.0mm | 9.4~10.6mm | 8.8/8.3 |
| SurfaceTreatment | N/A | N/A | N/A |
| Principle ofOperation | This product is a screw for connected with Abutment and fixture. | This product is a screw for connected with Abutment and fixture. | |
| Similarities | The subject device and primary predicate have same material, design, diameter, surface treatment, and principle of operation. | ||
| Differences | Differences in length are due to proprietary subject device dimensions and are supported by bench testing. |
2-7) Component – Cylinder
| Subject Device | Reference device | |
|---|---|---|
| Company | SNUCONE Co., LTD. | JJGC Indústria e Comércio de MateriaisDentários S.A. |
| Device Name | Screw Abutment Ti-Cylinder for SNUCONE Implant System | NUVO IF Implant System |
| 510(k) Number | K210354 | K193234 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Titanium Alloy (Ti-6Al-4V) |
| Design | Image: Screw Abutment Ti-Cylinder | Image: NUVO IF Implant System |
| Diameters(Ø) | Ø4.9 | Not Available in 510(k) Summary |
| Lengths(mm) | 12.7mm | Not Available in 510(k) Summary |
{14}------------------------------------------------
| Anodizing | Anodizing | Not Available in 510(k) Summary |
|---|---|---|
| Principle ofOperation | This product is connected to a Screw Abutment, and before installing the finalprosthesis, a temporary prosthesis is made and used in various cases such as overdenture and bridges. | Not Available in 510(k) Summary |
| Similarities | The subject device and the reference device have same raw materials and designs and have similar physical sizes such as diameter. Therefore, the subject device andreference device are practically the similar. |
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09. Non-Clinical Test
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device with the following standards:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
· Mechanical Performance
- Fatigue testing for Mini and Regular platform implant bodies with 25° Abiding Couple Angled Abutments was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and "ISO 14801:2016 Dentistry -Fatigue test for endosseous dental implants" under the worst case scenario.
- SEM/EDS analysis for worst-case implant body was conducted to confirm removal of the surface treatment media according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.".
= Sterilization, Shelf-life and Packaging for Sterile Product
- End User Sterilization Validation according to ISO 17665-1:2006, ISO 17665-2:2009, ISO 11737-1:2006, and ISO 11737-2:2009
- Gamma sterilization validation according to ISO 11737-1:2006, and ISO 11737-2:2009
- Accelerating aging test according to ASTM F1980-16, ASTM F1140-13, ASTM F1140-13, ASTM F1929-15, and ASTM F2096-11
▪ MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic SNUCONE Bone Level Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically 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 including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. 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.
▪ Bacterial Endotoxin
- ANSI/AAMI ST72:2019 Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing
· Biocompatibility
Subject device has been evaluated for biocompatibility according to ISO 10993
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device
10. Conclusion
SNUCONE Bone Level Implant System constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, SNUCONE Bone Level Implant System and its predicate device are substantially equivalent.
§ 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.