(265 days)
No
The summary describes a standard dental implant system and its components, focusing on mechanical performance, sterilization, and biocompatibility. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant system used to support dental prostheses, which is a reconstructive rather than therapeutic function.
No
Explanation: The device is a dental implant system used for supporting dental prostheses, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components like "Fixtures and Cover Screw, and Abutment and Component" which are hardware. The performance studies also focus on mechanical and material properties of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to support dental prostheses within the human body (mandibles and maxillae). This is a direct interaction with the patient's anatomy for structural support.
- Device Description: The device description details surgical components (fixtures, abutments, screws) that are implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body as a medical implant.
N/A
Intended Use / Indications for Use
SNUCONE Tissue Level Implant System is inticated 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 internediate Abutment support for fixed bridge work. Snucone 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.
Product codes
DZE, NHA
Device Description
SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull 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.
- Fixtures and Cover Screw
There is 1 type of fixture, and the dimensions and specification are as following:
| Product | EF | Cover Screw |
|---|---|---|
| Picture | Image: EF Implant | Image: Cover Screws |
| Diameter | Ø3.7, Ø3.8, Ø4.1, Ø4.3, Ø4.8, Ø5.3, Ø5.5, Ø5.8 | Ø5.5 / Ø6.7 |
| Length | Ø3.7: 7,8,9,10,11,12,13,14mm Ø3.8: 7,8,9,10,11,12,13,14mm Ø4.1: 7,8,9,10,11,12,13,14mm Ø4.3: 7,8,9,10,11,12,13,14mm Ø4.8: 7,8,9,10,11,12,13,14mm Ø5.3: 7,8,9,10,11,12,13,14mm Ø5.5: 7,8,9,10,11,12,13,14mm Ø5.8: 7,8,9,10,11,12,13,14mm | 8mm |
| Surface Treatment | Acid etching | Anodizing |
| Connection | Internal Octa | N/A |
| Material | Titanium Gr4 (ASTM F67) | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Shelf Life | 5 years | 5 years |
Tolerance of dimension shall be within ± 1% range.
- Abutment and Component
Dimensions and features of abutment are as following:
Tolerance of dimension shall be within ± 1% range.
| Abutment | Solid Abutment | InOcta Closing Screw | InOcta Healing Abutment | InOcta Abutment |
|---|---|---|---|---|
| Picture | Image: Solid Abutment | Image: InOcta Closing Screw | Image: InOcta Healing Abutment | Image: InOcta Abutment |
| Use | This device is a one-piece abutment that is secured to the Fixture without other component. | This device is connected to the Fixture and is used during healing period. | This device is used to connect with Fixture to help gum tissue around the implant site heal faster. | This device is a two-piece abutment that is secured to the Fixture with an abutment screw. |
| Principle of Operation | This product is a superstructure which is connects with the fixture. It is a one-body type Abutment of screw-retained that does not require an Abutment screw. It replaces the functions of the missing teeth as a dental Abutment. | This device is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture. When inserting the Abutment, This product is removed. | This product is healing Abutment to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. | This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental abutment. |
| Diameter | Ø3.5, Ø4.3 | Ø3.5 | Ø5.5, Ø6.1, Ø6.3 | Ø4.8, Ø5.2, Ø6.2 |
| Total Length | 9.5~13.0mm | 5.9mm | 9.0~11.5mm | 6.0~13.0mm |
| Gingival Height | - | - | 4.0~6.5mm | 0.0~4.0mm |
| Post Height | 4.0~7.0mm | - | - | 4.0~7.0mm |
| Angle(°) | N/A | N/A | N/A | N/A |
| Anodizing | N/A | Yellow | Yellow | N/A |
| Prosthetic retention | Cement-retained | - | - | Cement-retained |
| Restoration | Single-unit Multi-unit | - | - | Single-unit Multi-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 | InOcta Angled Abutment | InOcta Temporary Abutment | Platform Switching Abutment | - |
|---|---|---|---|---|
| Picture | Image: InOcta Angled Abutment | Image: InOcta Temporary Abutment | Image: Platform Switching Abutment | - |
| Use | This device is a two-piece abutment that is secured to the Fixture with an abutment screw. | This device is a two-piece abutment that is temporarily fixed to the Fixture with an abutment screw. This device is intended to be used for a maximum timeframe of 6 months. | This device is a one-piece abutment that is secured to the Fixture without other component. | - |
| Principle of Operation | This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental abutment. | It is dental Abutments designed to serve as a temporary dental prosthesis during the healing process until a permanent crown is made. | This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental abutment. | |
| Diameter | Ø3.8 | Ø5.2 | Ø4.5, Ø5.5, Ø6.5 | - |
| Total Length | 9.5mm | 12.5~14.5mm | 9.9~16.9mm | |
| Gingival Height | - | 1.0~3.0mm | 0.0~5.5mm | |
| Post Height | 7.0mm | 9.5mm | 5.5mm | - |
| Angle(°) | 15° 25° | N/A | N/A | - |
| Anodizing | N/A | N/A | N/A | - |
| Prosthetic retention | Cement-retained | Cement-retained | Cement-retained | |
| Restoration | Single-unit Multi-unit | Single-unit Multi-unit | Single-unit Multi-unit | |
| Material | 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 | |
| Shelf Life | N/A | N/A | N/A | - |
2-2) Abutment Screw
Dimensions and features of component are as following:
| Abutment Screw | InOcta Abutment Screw |
|---|---|
| Picture | Image: Abutment Screw |
| Use | This product is a screw used to connect both two-piece Abutment to the Fixture |
| Principle of Operation | This product is a screw for connected with Abutment and fixture. |
| Size | D : Ø2.5 / L : 4.5~8.0mm |
| Material | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | End user sterilized |
Tolerance of dimension for InOcta Abutment screw shall be within ± 1% range.
Fixture is packaged with Cover Screw, Abutment is packaged with single-packing or components, in some cases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
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)
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 complies with the following standards:
· Mechanical Performance
- Fatigue testing for worst-case implant body EF1.8-3714S with 25° InOcta Angled Abutment 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 Dentisty - 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 suface treatment media according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implant Abutment.".
■ 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, and ISO 11737-2
- 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 Tissue 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 standards and demonstrated the substantial equivalence with the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K141159, K121585, K181138, K200189, K120043, K201700, K190637, K210161
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SNUCONE Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142 Gasan digital 1-ro Geumcheon-gu. Seoul 08507 REPUBLIC OF KOREA
Re: K222792
Trade/Device Name: SNUCONE Tissue Level Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 8, 2023 Received: May 8, 2023
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 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)
Device Name
SNUCONE Tissue Level Implant System
Indications for Use (Describe)
SNUCONE Tissue Level Implant System is inticated 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 internediate Abutment support for fixed bridge work. Snucone 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)
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3
The assigned 510(k) Number: K222792
01. Date Prepared: May 29, 2023
02. Applicant
Company name: SNUCONE Co., LTD. Address: 5, Seongseo-ro 75-gil, Dalseo-qu, 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 Tissue 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 Tissue 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 and terminal or intermediate Abutment support for fixed bridge work. Snucone 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
- K181137, IT-III active System manufactured by NEOBIOTECH CO., LTD
Reference Devices
- K141159, K3Pro Konus Dental Implant System. Argon Med. Productions & Vertriebs Gesellschaft mbh & Co. KG
- K121585, TS Implant System by Osstem Implant Co., Ltd.
- K181138, IS-III active System manufactured by NEOBIOTECH CO., LTD
- K200189, Luna Dental Implant System-Healing Abutment, Shinhung MST CO., LTD
- K120043, CSM Internal-R Implant System, CSM Implant
- K201700, BEGO Semados® RS/RSX Implant System by BEGO Implant Systems GmbH & Co. KG
- K190637, Fit & Brilliant Dental Implant System, F&B Technology CO., LTD
- K210161, Any One Onestage Implant System by MegaGen Implant Co., Ltd.
4
07. Device Description
SNUCONE Implant System Fixture, also known as an endosseous implant, is surgical component that interfaces with the bone of the jaw or skull 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.
- Fixtures and Cover Screw
There is 1 type of fixture, and the dimensions and specification are as following:
| Product | EF | Cover Screw |
|---|---|---|
| Picture | Image: EF Implant | Image: Cover Screws |
| Diameter | Ø3.7, Ø3.8, Ø4.1, Ø4.3, | |
| Ø4.8, Ø5.3, Ø5.5, Ø5.8 | Ø5.5 / Ø6.7 | |
| Length | Ø3.7: 7,8,9,10,11,12,13,14mm | |
| Ø3.8: 7,8,9,10,11,12,13,14mm | ||
| Ø4.1: 7,8,9,10,11,12,13,14mm | ||
| Ø4.3: 7,8,9,10,11,12,13,14mm | ||
| Ø4.8: 7,8,9,10,11,12,13,14mm | ||
| Ø5.3: 7,8,9,10,11,12,13,14mm | ||
| Ø5.5: 7,8,9,10,11,12,13,14mm | ||
| Ø5.8: 7,8,9,10,11,12,13,14mm | 8mm | |
| Surface | ||
| Treatment | Acid etching | Anodizing |
| Connection | Internal Octa | N/A |
| Material | Titanium Gr4 (ASTM F67) | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Shelf Life | 5 years | 5 years |
Tolerance of dimension shall be within ± 1% range.
2) Abutment and Component
2-1) Abutment
Dimensions and features of abutment are as following:
Tolerance of dimension shall be within ± 1% range.
| Abutment | Solid Abutment | InOcta Closing Screw | InOcta Healing Abutment | InOcta Abutment |
|---|---|---|---|---|
| Picture | Image: Solid Abutment | Image: InOcta Closing Screw | Image: InOcta Healing Abutment | Image: InOcta Abutment |
| Use | This device is a one-piece | |||
| abutment that is secured | ||||
| to the Fixture without other | ||||
| component. | This device is connected to | |||
| the Fixture and is used | ||||
| during healing period. | This device is used to | |||
| connect with Fixture to | ||||
| help gum tissue around | ||||
| the implant site heal faster. | This device is a two-piece | |||
| abutment that is secured | ||||
| to the Fixture with an | ||||
| abutment screw. | ||||
| Principle of | This product is a | This device is used for | This product is healing | This product is a |
| Operation | superstructure which is | |||
| connects with the fixture. It | ||||
| is a one-body type | ||||
| Abutment of screw- | ||||
| retained that does not | ||||
| require an Abutment | ||||
| screw. It replaces the | ||||
| functions of the missing | ||||
| teeth as a dental | ||||
| Abutment. | protecting inner hole and | |||
| connecting part with | ||||
| exposed upper part of | ||||
| structure during the healing | ||||
| period after inserting dental | ||||
| implant fixture. When | ||||
| inserting the Abutment, This | ||||
| product is removed. | Abutment to formation | |||
| appropriate gingival shape | ||||
| during the soft tissue | ||||
| healing period combined | ||||
| with implant. This product | ||||
| should be removed when | ||||
| the superstructure is set | ||||
| up. | superstructure which is | |||
| connects with the fixture | ||||
| using the enclosed | ||||
| Abutment screw. It | ||||
| replaces the functions of | ||||
| the missing teeth as a | ||||
| dental abutment. | ||||
| Diameter | Ø3.5, Ø4.3 | Ø3.5 | Ø5.5, Ø6.1, Ø6.3 | Ø4.8, Ø5.2, Ø6.2 |
| Total Length | 9.5~13.0mm | 5.9mm | 9.0~11.5mm | 6.0~13.0mm |
| Gingival Height | - | - | 4.0~6.5mm | 0.0~4.0mm |
| Post Height | 4.0~7.0mm | - | - | 4.0~7.0mm |
| Angle(°) | N/A | N/A | N/A | N/A |
| Anodizing | N/A | Yellow | Yellow | N/A |
| Prosthetic | ||||
| retention | Cement-retained | - | - | Cement-retained |
| Restoration | Single-unit | |||
| Multi-unit | - | - | Single-unit | |
| Multi-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 | InOcta Angled | |||
| Abutment | InOcta Temporary Abutment | Platform Switching | ||
| Abutment | - | |||
| Picture | Image: InOcta Angled Abutment | Image: InOcta Temporary Abutment | Image: Platform Switching Abutment | - |
| Use | This device is a two-piece | |||
| abutment that is secured | ||||
| to the Fixture with an | ||||
| abutment screw. | This device is a two-piece | |||
| abutment that is temporarily | ||||
| fixed to the Fixture with an | ||||
| abutment screw. This device | ||||
| is intended to be used for a | ||||
| maximum timeframe of 6 | ||||
| months. | This device is a one-piece | |||
| abutment that is secured | ||||
| to the Fixture without other | ||||
| component. | - | |||
| Principle of | ||||
| Operation | This product is a | |||
| superstructure which is | ||||
| connects with the fixture | ||||
| using the enclosed | ||||
| Abutment screw. It | ||||
| replaces the functions of | ||||
| the missing teeth as a | ||||
| dental abutment. | It is dental Abutments | |||
| designed to serve as a | ||||
| temporary dental prosthesis | ||||
| during the healing process | ||||
| until a permanent crown is | ||||
| made. | This product is a | |||
| superstructure which is | ||||
| connects with the fixture | ||||
| using the enclosed | ||||
| Abutment screw. It | ||||
| replaces the functions of | ||||
| the missing teeth as a | ||||
| dental abutment. | ||||
| Diameter | Ø3.8 | Ø5.2 | Ø4.5, Ø5.5, Ø6.5 | - |
| Total Length | 9.5mm | 12.5~14.5mm | 9.9~16.9mm | |
| Gingival Height | - | 1.0~3.0mm | 0.0~5.5mm | |
| Post Height | 7.0mm | 9.5mm | 5.5mm | - |
| Angle(°) | 15° 25° | N/A | N/A | - |
| Anodizing | N/A | N/A | N/A | - |
| Prosthetic | ||||
| retention | Cement-retained | Cement-retained | Cement-retained | |
| Restoration | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | Single-unit | |||
| Multi-unit | ||||
| Material | 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 | |
| Shelf Life | N/A | N/A | N/A | - |
5
6
2-2) Abutment Screw
Dimensions and features of component are as following:
| Abutment Screw | InOcta Abutment Screw |
|---|---|
| Picture | Image: Abutment Screw |
| Use | This product is a screw used to connect both two-piece |
| Abutment to the Fixture | |
| Principle of | |
| Operation | This product is a screw for connected with Abutment |
| and fixture. | |
| Size | D : Ø2.5 / L : 4.5~8.0mm |
| Material | Ti 6Al-4V ELI (ASTM F136) |
| Sterilization | End user sterilized |
Tolerance of dimension for InOcta Abutment screw shall be within ± 1% range.
Fixture is packaged with Cover Screw, Abutment is packaged with single-packing or components, in some cases.
7
08. Substantial Equivalence Comparison
- Fixture
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | Argon Med Productions&Vertriebs Gesellschaft |
| mbH&Co.KG | |||
| Device Name | EF Fixture for SNUCONE Tissue Level Implant System | IT-III active System | K3Pro Konus Dental Implant |
| 510(k) Number | Not Assigned Yet. | K181137 | K141159 |
| Device | |||
| Classification | |||
| Name | Implant, Endosseous, | ||
| Root-Form | Implant, Endosseous, | ||
| Root-Form | Implant, Endosseous, | ||
| Root-Form | |||
| Product Code | DZE | DZE | DZE |
| Regulation Number | 872.3640 | 872.3640 | 872.3640 |
| Indications for Use | SNUCONE Tissue 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 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. | The IT-III active 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. IT- | |||
| III active system is dedicated for two stage surgical | |||
| procedures and for immediate loading when there is | |||
| good primary stability and an appropriate occlusal | |||
| loading. | The Konus K3Pro and K3Pro Rapid Implant is designed | ||
| for use in edentulous sites in the mandible or maxilla for | |||
| support of a complete denture prosthesis, a terminal or | |||
| intermediate abutment for fixed bridgework or for partial | |||
| dentures, or as a single tooth replacement. | |||
| Material | Titanium Gr4 (ASTM F67) | Pure Titanium of ASTM F67 | Pure Titanium Grade 4 |
| Design | Image: Two titanium implants | Image: Two titanium implants | Image: Two titanium implants |
| Connection | Internal Octa | Internal Octa | Internal Hex |
| Diameters(ø) | $Ø$ 3.7, $Ø$ 3.8, $Ø$ 4.1, $Ø$ 4.3, $Ø$ 4.8, $Ø$ 5.3, $Ø$ 5.5, $Ø$ 5.8 | 3.5/4.0/4.5/5.0/5.5/6.0/7.0 | 3.0-6.0mm |
| Lengths(mm) | $Ø$ 3.7: 7,8,9,10,11,12,13,14mm | ||
| $Ø$ 3.8: 7,8,9,10,11,12,13,14mm | |||
| $Ø$ 4.1: 7,8,9,10,11,12,13,14mm | |||
| $Ø$ 4.3: 7,8,9,10,11,12,13,14mm | |||
| $Ø$ 4.8: 7,8,9,10,11,12,13,14mm | 7.0/8.5/10.0/11.5/13.0/15.0 | 7.5-17mm | |
| Ø5.3: 7,8,9,10,11,12,13,14mm | |||
| Ø5.5: 7,8,9,10,11,12,13,14mm | |||
| Ø5.8: 7,8,9,10,11,12,13,14mm | |||
| Surface Treatment | Acid etching | SLA | Acid etching |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Principle of | |||
| Operation | This product is a root-type fixture which is inserted in the | ||
| alveolar bone. It replaces the functions of the missing | |||
| teeth as a dental implant fixture. | This product is a root-type fixture which is inserted in the | ||
| alveolar bone. It replaces the functions of the missing | |||
| teeth as a dental implant fixture. | Unknown | ||
| Similarities | SNUCONE Tissue Level Fixture has the same device characteristics with the primary predicate such as Indication for use, material, design, connection, diameter, length, | ||
| sterilization method, and principle of operation. | |||
| The surface treatment is applied to the threaded part only of the subject device and primary predicate. The upper portion of EF Fixture is pure titanium without surface | |||
| treatment | |||
| Differences | The difference between the subject device and the Predicate device are surface treatment. The surface treatment method of the subject fixture is Acid etching while the | ||
| primary predicate is SLA. To support this inconsistency, K141159 is added as a reference device to support the difference in surface treatment method. |
8
1-2) Cover Screw
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | Osstem Implant Co., Ltd. |
| Device Name | Cover screw for SNUCONE Tissue Level Implant | ||
| System | IT-III active System | TS Implant System | |
| 510(k) Number | Not Assigned Yet. | K181137 | K121585 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Yellow and blue cover screw | Image: Gray cover screw | Image: Green cover screw |
| Diameters(ø) | Yellow: Ø5.5 | ||
| Sky blue: Ø6.7 | 5.5/6.9 | 4.0/4.5/5.0/6.0/7.0 | |
| Height (mm) | 3.0mm | Cuff Length: 6.0 | Height: 0.4, 1.4, 2.0 |
| Anodizing | Anodizing | Non-Anodizing | Anodizing |
| Sterilization | Gamma irradiation | Gamma Sterilization | - |
| Principle of | |||
| Operation | This product connects with the Dental Implant Fixture to | ||
| protect the inside of the fixture during bone fusion period | |||
| after installation of Dental Implant Fixture, and removes | |||
| the cover screw before inserting the Abutment. | Cover screw as a set of medical devices is used for | ||
| protecting inner hole and connecting part with exposed | |||
| upper part of structure during the healing period after | |||
| inserting dental implant fixture. When inserting the | |||
| Abutment, Cover screw is removed. | Cover screw as a set of medical devices is used for | ||
| protecting inner hole and connecting part with exposed | |||
| upper part of structure during the healing period after | |||
| inserting dental implant fixture. When inserting the | |||
| Abutment, Cover screw is removed. | |||
| Similarities | The subject and primary predicate devices have the same material, design, principle of operation, and similar diameter. | ||
| Differences | There is a slightly different surface treatment between the subject device and primary predicate. To support this inconsistency, K121585 is added as a reference device to | ||
| support the difference in surface treatment method. |
9
2) Abutment, Abutment Screw and Component
2-1) Solid Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | Solid Abutment for SNUCONE Tissue Level Implant System | IT-III active System |
| 510(k) Number | Not Assigned Yet. | K181137 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Solid Abutment for SNUCONE Tissue Level Implant System | Image: IT-III active System |
| Diameters(Ø) | Ø3.5, Ø4.3 | 3.5/4.3 |
| Post Heights (mm) | 4.0~7.0mm | 4.0/5.5/7.0 |
| Anodizing | Non-Anodizing | Anodizing / Non-Anodizing |
| Sterilization | End user sterilized | End user sterilized |
| Principle of Operation | This product is a superstructure which is connects with the fixture. It is a one-body type Abutment of screw-retained that does not require an Abutment screw. It replaces the functions of the missing teeth as a dental Abutment. | This product is a superstructure which is connects with the fixture. It is a one-body type Abutment of screw-retained that does not require an Abutment screw. It replaces the functions of the missing teeth as a dental Abutment. |
| Similarities | The subject and primary predicate devices have the same material, design, diameter, principle of operation and similar post height. |
2-2) InOcta Closing Screw
| Subject Device | Reference Device | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | InOcta Closing Screw for SNUCONE Tissue Level Implant System | IS-III active System |
| 510(k) Number | Not Assigned Yet. | K181138 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
| Design | Image: Subject Device Design | Image: Reference Device Design |
| Diameters(Ø) | $Ø$ 3.5 | 3.45/3.6 |
| Lengths(mm) | 5.9mm | 5.85/6.85/7.45/ 6.4/7.4/8.0 |
| Anodizing | Anodizing | Anodizing/ Non-Anodizing, |
10
| Sterilization | End user sterilized | Gamma irradiation |
|---|---|---|
| Principle of | ||
| Operation | This device is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture. When inserting the Abutment, This product is removed. | It is used for protecting inner hole and connecting part with exposed upper part of structure during the healing period after inserting dental implant fixture. When inserting the Abutment, Cover screw is removed. |
| Similarities | The subject device and reference devices have the same material, design, surface treatment, principle of operation and similar diameter and length. |
2-3) InOcta Healing Abutment
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | SHINHUNG MST Co., Ltd. |
| Device Name | InOcta Healing Abutment for SNUCONE Tissue Level | ||
| Implant System | IT-III active System | Luna Dental Implant System - Healing Abutment | |
| 510(k) Number | Not Assigned Yet. | K181137 | K200189 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | Ti-Gr4 |
| Design | Image: [yellow abutment] | Image: [silver abutment] | Image: [purple and silver abutment] |
| Diameters(ø) | Ø5.5, Ø6.1, Ø6.3 | 5.8/6.3/7.1/7.2 | 4.3, 4.8, 5.8, 6.3 |
| Gingival | |||
| Heights(mm) | 4.0~6.5mm | 1.5/2.5/3.5/4.5/5.5/6.5 | Lengths: 9.2, 10, 10.2, 11, 11.2, 12, 12.2, 13, 13.2, 14 |
| Anodizing | Anodizing | N/A | Anodizing |
| Principle of | |||
| Operation | This product is healing Abutment to formation | ||
| appropriate gingival shape during the soft tissue healing | |||
| period combined with implant. This product should be | |||
| removed when the superstructure is set up. | This product is healing Abutment to formation | ||
| appropriate gingival shape during the soft tissue healing | |||
| period combined with implant. This product should be | |||
| removed when the superstructure is set up. | Unknown | ||
| Sterilization | End user sterilized | Gamma Sterilization | Unknown |
| Similarities | The subject and primary predicate devices have the same material, design, principle of operation and similar diameter, gingival height. | ||
| Differences | The diameter of the subject device includes Ø5.5 that is slightly smaller than the primary predicate. To support this inconsistency, K200189 is added as a reference device | ||
| to support the difference in diameter. |
2-4) InOcta Abutment
| Subject Device | Primary Predicate | |
|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd |
| Device Name | InOcta Abutment for SNUCONE Tissue Level Implant System | IT-III active System |
| 510(k) Number | Not Assigned Yet. | K181137 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 |
11
| Design | Image: Octa | Image: Non-Octa | Image: Octa | Image: Non-Octa | Image: SCRP | |
|---|---|---|---|---|---|---|
| Diameters(ø) | Ø4.8, Ø5.2, Ø6.2 | 4.3/4.85/5.5/6.55 | ||||
| Gingival | ||||||
| Heights(mm) | 0.0~4.0mm | 0/1/2/3/4 | ||||
| Anodizing | Non-Anodizing | TiN-Coating | ||||
| Principle of | ||||||
| Operation | This product is a superstructure which is connects with the fixture using the enclosed | |||||
| Abutment screw. It replaces the functions of the missing teeth as a dental abutment. | This product is a superstructure which is connects with the fixture | |||||
| using the enclosed Abutment screw. It replaces the functions of | ||||||
| the missing teeth as a dental Abutment. | ||||||
| Sterilization | End user sterilized | End user sterilized | ||||
| Similarities | The subject and primary predicate devices have the same material, design, principle of operation, gingival height, and similar diameter |
2-5) InOcta Angled Abutment
| Subject Device | Primary Predicate | ||
|---|---|---|---|
| Company | SNUCONE Co., LTD. | Neobiotech Co., Ltd | |
| Device Name | InOcta Angled Abutment for SNUCONE Tissue Level Implant System | IT-III active System | |
| 510(k) Number | Not Assigned Yet. | K181137 | |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI of ASTM F136 | |
| Design | Image: Octa | Image: Octa | Image: Non-Octa |
| Octa | Octa | Non-Octa | |
| Diameters(Ø) | Ø3.8 | 3.7/4.3 | |
| Lengths(mm) | 9.5mm | 9.5/9.68 | |
| Angle(°) | 15° 25° | 15° 25° | |
| Anodizing | Non-Anodizing | Non-Anodizing | |
| Principle of Operation | This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental abutment. | This product is a superstructure which is connects with the fixture using the enclosed Abutment screw. It replaces the functions of the missing teeth as a dental Abutment. | |
| Sterilization | End user sterilized | End user sterilized |
12
Similarities The subject and primary predicate devices have material, design, angle, surface treatment, principle of operation, and similar diameter, length.
2-6) InOcta Temporary Abutment
| Subject Device | Reference Device | |
|---|---|---|
| Company | SNUCONE Co., LTD. | BEGO Implant Systems GmbH & Co. KG |
| Device Name | InOcta Temporary Abutment for SNUCONE Tissue | |
| Level Implant System | PS TTIA and PS TTIA NH | |
| 510(k) Number | Not Assigned Yet. | K201700 |
| Material | Ti-6Al-4V ELI of ASTM F136 | Ti-6Al-4V ELI (ASTM F136) |
| Design | Image: Two implants | Image: Two implants |
| Diameters(ø) | 05.2 | 3.2, 3.7, 4.1, 5.1mm |
| Lengths(mm) | 12.5~14.5mm | Overall height: 12mm |
| Anodizing | Non-Anodizing | N/A |
| Principle of | ||
| Operation | It is dental Abutments designed to serve as a temporary | |
| dental prosthesis during the healing process until a | ||
| permanent crown is made. | Unknown | |
| Maximum | ||
| timeframe for use | ≤ 6 month |