(311 days)
No
The 510(k) summary describes a dental implant system made of titanium and titanium alloy, along with associated prosthetic components. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies described are mechanical fatigue tests, not related to data analysis or algorithmic processing.
No.
The device is a dental implant system used for prosthetic restoration, which replaces missing teeth but does not treat a disease or condition therapeutically.
No
The device described is an implant system (fixtures and prosthetic components) used for dental restoration, not for diagnosing conditions.
No
The device description explicitly details physical components made of titanium, titanium alloy, CCM alloy, and POM, intended for surgical implantation and prosthetic restoration. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the IH Implant System and IH Prosthetic System are devices made of titanium and titanium alloy intended for surgical placement in the bone of the jaw and for prosthetic restoration. They are physical implants and components used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures typically associated with IVDs.
Therefore, the IH Implant System and IH Prosthetic System are medical devices, but they fall under a different category than In Vitro Diagnostics. They are likely considered dental implants and prosthetic components.
N/A
Intended Use / Indications for Use
IH Implant System is device made of Titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).
IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles. Healing Abutment has a various diameters 4 to 6.5mm (4, 4.5, and 5, 5.5, 6 and 6.5 mm) and lengths 7.5 to 12.4mm (7.5, 8.4, 9.5, 10.4, 11.5 and 12.4mm). Solid Abutment has various diameters 4 to 7mm (4, 4.5, and 6.5 mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Cement Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Angled Abutment has various diameters 4.5 to 6mm (4.5, 5.5 and 6mm), gingival heights 2 to 4mm ( 2, 3, and 4mm), heights 7.5 to 8mm (7.5 and 8mm) and angle 15° to 25° (15° and 25°), Temporary Abutment has various diameters 4 to 4.5mm (4 and 4.5mm), gingival heights 1 to 3mm (1 and 3mm) and height 9.6mm. Multi-unit Abutment has various diameters 4.7 to 5.13mm (4.7, 4.8 and 5.13mm), gingival heights 1.5 to 4.5mm (1.5, 2.5, 3.5 and 4.5mm) and angle 17° to 30° (17° and 30°) and FreeMilling Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 3mm (1, 2 and 3mm) and heights 10 to 12mm (10, 11 and 12mm). IH Prosthetic System is device made of titanium, titanium alloy, CCM alloy and POM. Angled Abutment, Temporary Abutment, Healing Cap, Temporary Cylinder and FreeMilling Abutment are made of titanium. Healing Abutment, Solid Abutment, Cement Abutment, Multi-unit Abutment Screw and Cylinder Screw are made of titanium alloy. CCM Cylinder is made of Cobalt-Chrome-Molybdenum alloy. Solid Protect Cap and Plastic Cylinder are made of POM.
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)
Summary of non-clinical testing:
Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations.
Fatigue testing for IH2 SLA Fixture and IH 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 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices.
Biocompatibility:
- Fixture: Cytotoxicity (OK), Sensitization (OK), Intracutaneous Reactivity (OK), Acute Systemic (OK), Implantation (OK), Genotoxicity (OK)
- Prosthetic: Cytotoxicity (OK), Sensitization (OK), Irritation (OK), Acute Systemic (OK), Genotoxicity (OK)
Roughness of SLA Surface (Ra): 2.861 ± 0.262 micro meter
Sterilization Validation: VDmax 25 SAL 10-6
Packaging Validation (Shelf life): 5 years
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Sewon Medix Inc. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K153521
Trade/Device Name: IH Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 12, 2016 Received: September 16, 2016
Dear April 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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image contains the logo for Sewonmedix Inc., a dental implant system company. The logo features a stylized, colorful graphic to the left of the company name, which is written in a bold, blue font. Below the main logo, the text "Sewonmedix Inc." is written in a smaller, serif font. The overall design is clean and professional, reflecting the company's focus on dental implants.
9, Sa-sang-ro, 375beon-gil, Sa-sang-gu, Busan, Korea Tel : +82.51.303.1713/Fax : +82.51.303.1714 / www.sewonmedix.com
Indication for Use Statement
510(k) Number: K 153521
Device Name: IH Implant System
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _ _ _ _ _ _
(Per 21CFR801 Subpart D)
(Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
This summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Submitter
Sewon Medix Inc. Mr. Bum-keun Park #29, Sa-sang-ro, 375beon-gil, Sa-sang-gu, Busan, South Korea Email: iceing99@sewonmedix.com Tel. +82-51-303-1713 Fax. +82-51-303-1714
Official Correspondent
Withus Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
- Trade Name: IH Implant System
- Common Name: Dental Implant System ●
- Classification Name: Endosseous dental implant
- Primary Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640 ●
- Device Class: Class II
- Date prepared: 10/05/2016 .
General Description :
IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).
IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles. Healing Abutment has a various diameters 4 to 6.5mm (4, 4.5, and 5, 5.5, 6 and 6.5 mm) and lengths 7.5 to 12.4mm (7.5, 8.4, 9.5, 10.4, 11.5 and 12.4mm). Solid Abutment has various diameters 4 to 7mm (4, 4.5, and 6.5 mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Cement Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 5mm (1, 1.5, 2, 2.5, 3, and 3.5, 4, 4.5 and 5 mm) and heights 4 to 7mm (4, 5.5 and 7mm). Angled Abutment has various diameters 4.5 to 6mm (4.5, 5.5 and 6mm), gingival heights 2 to 4mm ( 2, 3, and 4mm), heights 7.5 to 8mm (7.5 and 8mm) and angle 15° to 25° (15° and 25°), Temporary Abutment has various diameters 4 to 4.5mm (4 and
4
4.5mm), gingival heights 1 to 3mm (1 and 3mm) and height 9.6mm. Multi-unit Abutment has various diameters 4.7 to 5.13mm (4.7, 4.8 and 5.13mm), gingival heights 1.5 to 4.5mm (1.5, 2.5, 3.5 and 4.5mm) and angle 17° to 30° (17° and 30°) and FreeMilling Abutment has various diameters 4.5 to 6.5mm (4.5, 5, 5.5, 6 and 6.5mm), gingival heights 1 to 3mm (1, 2 and 3mm) and heights 10 to 12mm (10, 11 and 12mm). IH Prosthetic System is device made of titanium, titanium alloy, CCM alloy and POM. Angled Abutment, Temporary Abutment, Healing Cap, Temporary Cylinder and FreeMilling Abutment are made of titanium. Healing Abutment, Solid Abutment, Cement Abutment, Multi-unit Abutment Screw and Cylinder Screw are made of titanium alloy. CCM Cylinder is made of Cobalt-Chrome-Molybdenum alloy. Solid Protect Cap and Plastic Cylinder are made of POM.
Indications for Use:
IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained or screw retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Predicate Device:
Substantial Equivalence Matrix (IH2 SLA Fixture)
- . TS Fixture System, OSSTEM Implant Co., Ltd. K121995 - primary predicate
- Straumann® Bone Level Tapered Implant, Institut Straumann Ag, K140878 ●
| IH2 SLA Fixture | Predicate devices | ||
|---|---|---|---|
| primary predicate | reference predicate | ||
| TS Fixture System | Straumann® Bone | ||
| Level Tapered Implant | |||
| Manufacturer | Sewon Medix Inc. | OSSTEM Implant Co., | |
| Ltd. | Institut Straumann Ag | ||
| Design | Image: IH2 SLA Fixture | Image: TSIII SA Fixture | Image: Straumann Bone Level Tapered Implant |
| 510(k) No. | K153521 | K121995 | K140878 |
| Indication for | |||
| Use | IH Implant System is | ||
| device made of titanium | |||
| and titanium alloy | |||
| indicated for in partially | |||
| or fully edentulous | |||
| mandibles and maxillae, | |||
| in support of single or | The TS Fixture System | ||
| is indicated for use in | |||
| partially or fullly | |||
| edentulous mandibles | |||
| and maxillae, in support | |||
| of single or multiple unit | |||
| restorations including; | |||
| cemented retained, screw | Straumann® dental | ||
| implants are indicate for | |||
| oral endosteal | |||
| implantation in the upper | |||
| and low jaw and for the | |||
| functional and esthetic | |||
| oral rehabiliation of | |||
| edentulous and partially | |||
| multiple-unit restorations | |||
| including; cemented | |||
| retained or screw | |||
| retained restorations and | |||
| terminal or interminal | |||
| abutment support for | |||
| fixed bridgework. IH | |||
| Implant System is for | |||
| single and two stage | |||
| surgical procedures. It is | |||
| intended for delayed | |||
| loading. | retained, or overdenture | ||
| restorations, and final or | |||
| temporary abutment | |||
| support for fixed bridge | |||
| work. It is intended for | |||
| delayed loading. | dentate patients. | ||
| Straumann dental | |||
| implants can also be | |||
| used for immedicate or | |||
| early implantation | |||
| following extraction or | |||
| loss of natural teeth. | |||
| Implants can be placed | |||
| with immediate function | |||
| on single-tooth and/or | |||
| multiple tooth | |||
| applications when good | |||
| primary stability is | |||
| achieved and with | |||
| appropriate occlusal | |||
| loading, to restore | |||
| chewing function. The | |||
| prosthetic restorations | |||
| used are single crowns, | |||
| bridge and partial or full | |||
| dentures, which are | |||
| connected to the | |||
| implants by the | |||
| correponding | |||
| elements(abutments). In | |||
| case of fully edentulous | |||
| patients, 4 or more | |||
| implants must be used in | |||
| immediately loaded | |||
| case. | |||
| Surgery Type | One or two stage | ||
| Surgery | One or two stage | ||
| Surgery | One or two stage | ||
| Surgery | |||
| Structure | - Internal Hex connected |
- Submerged fixture
- Tapered body shape
- Cutting edge with self-
tapping - 0.8mm thread pitch | - Internal Hex connected
- Submerged fixture
- Tapered body shape
(TSIII SA Fixture) - Cutting edge with self-
tapping - 0.8mm thread pitch | - Internal connected
- Submerged fixture
- Tapered body shape
- Cutting flutes
- 0.8mm thread pitch |
| Connection
Type | Internal hex connection | Internal hex connection | Internal connection |
| Diameter (D) | 3.7, 4.2, 4.6, 5.1 | TSIII SA Fixture
3.75, 3.77, 4.2, 4.25, 4.6
4.63, 4.65, 5.05, 5.08,
5.1 | 3.3, 4.1, 4.8 |
| Length (mm) | 8.5, 10, 11.5, 13, 15 | 7, 8.5, 10, 11.5, 13, 15 | 8, 10, 12, 14, 16 |
| Material of
Fixture | Pure Titanium Grade 4
(ASTMF67-06) | Pure Titanium Grade 4
(ASTMF67-06) | Pure Titanium Grade 4
(ASTMF67-06) |
| Surface | SLA | SA | SLA |
5
6
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
|---|---|---|---|
| Shelf life | 5 years | 8 years | - |
Substantial Equivalence Matrix (IH Prosthetic System)
- Hiossen Prosthetic System, OSSTEM Implant Co., Ltd., K140507 - primary predicate
- Multi Angled Abutment, OSSTEM Implant Co., Ltd., K123755
- . Healing Abutment, OSSTEM Implant Co., Ltd., K081575
| IH Prosthetic System | Predicate devices | |||
|---|---|---|---|---|
| primary predicate | reference predicate | |||
| Hiossen Prosthetic System | Multi Angled Abutment | Healing Abutment | ||
| Manufacturer | Sewon Medix Inc. | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Design | Image: Healing | - | - | Image: Healing |
| Image: Solid | Image: Rigid | - | - | |
| Image: Cement | Image: Transfer | - | - | |
| Image: Angled | Image: Angled | - | - | |
| Image: Temporary | Image: Temporary | |||
| Image: Straight Angled Multi-Unit | Image: Convertible | Image: Multi Angle | ||
| Image: FreeMilling | Image: Freeform | |||
| 510(k) No. | K140507 | K123755 | K081575 | |
| Description | Healing Abutment is | |||
| used to make a soft | ||||
| tissue shape before | ||||
| setting up prosthetics | ||||
| and removing cover | ||||
| screw after | ||||
| osseointergration. | ||||
| Angled Abutment is | ||||
| an abutment which has | ||||
| certain angle to easy | ||||
| for adjustment of | ||||
| installation angle of | ||||
| prosthesis. | ||||
| Temporary Abutment | ||||
| is used temporary until | ||||
| final prosthesis is | ||||
| made to maintain | ||||
| esthetic appreciation | ||||
| and chew ability. | ||||
| Multi-Unit Abutment | ||||
| is used for screw | ||||
| retained multiple case. | ||||
| Solid, Cement and | The Hiossen | |||
| Prosthetic System is | ||||
| intended for use an | ||||
| aid in prosthetic | ||||
| restoration. It | ||||
| consists of | ||||
| Abutment, | ||||
| overdenture | ||||
| components and | ||||
| Abutment Screws. | ||||
| The Hiossen | ||||
| Prosthetic system is | ||||
| similar to other | ||||
| commercially | ||||
| available products | ||||
| base on the intended | ||||
| use, the technology | ||||
| used, the claims, the | ||||
| material composition | ||||
| employed and | ||||
| permanence | ||||
| characteristics. | Multi Angled | |||
| Abutment is | ||||
| used to elevate | ||||
| restoration | ||||
| platform when | ||||
| restoration to | ||||
| implant level | ||||
| is not practical | ||||
| due to depth or | ||||
| angle of | ||||
| implant for the | ||||
| edentulous | ||||
| patients in | ||||
| Anterior and | ||||
| Posterior , not | ||||
| customizable | ||||
| and can't be | ||||
| use a single | ||||
| product. | Used to make | |||
| a soft tissue | ||||
| shape before | ||||
| setting up | ||||
| prosthetics and | ||||
| removing | ||||
| cover screw | ||||
| after | ||||
| osseointergrati | ||||
| on. | ||||
| to fabricate a | ||||
| prosthesis of internal | ||||
| single & bridge | ||||
| cement retained type. | ||||
| Indication for | ||||
| Use | IH Implant System is | |||
| device made of | ||||
| titanium and titanium | ||||
| alloy indicated for in | ||||
| partially or fully | ||||
| edentulous mandibles | ||||
| and maxillae, in | ||||
| support of single or | ||||
| multiple-unit | ||||
| restorations including; | ||||
| cemented retained or | ||||
| screw retained | ||||
| restorations and | ||||
| terminal or interminal | ||||
| abutment support for | ||||
| fixed bridgework. IH | ||||
| Implant System is for | ||||
| single and two stage | ||||
| surgical procedures. It | ||||
| is intended for delayed | ||||
| loading. | Hiossen Prosthetic | |||
| System is intended | ||||
| for use with a dental | ||||
| implant to provide | ||||
| support for prosthetic | ||||
| restorations such as | ||||
| crowns, bridges, or | ||||
| overdentures. | Multi Angled | |||
| Abutment is | ||||
| intended for | ||||
| use a dental | ||||
| implant to | ||||
| provide | ||||
| support for | ||||
| prosthetic | ||||
| restoration | ||||
| such as | ||||
| crowns, | ||||
| bridges, or | ||||
| overdentures. | HU/HS/HG | |||
| Prosthetic | ||||
| System is | ||||
| intended for | ||||
| use as an aid | ||||
| presthetic | ||||
| restioration. | ||||
| Structure | External Hex | External Hex | External Hex | - |
| Connection | ||||
| Type | Screw & External | |||
| Hex-Connected | Screw & External | |||
| Hex-Connected | Screw & | |||
| External Hex- | ||||
| Connected | Screw | |||
| Connected | ||||
| Diameter (D) | Healing : | |||
| 4.0/4.5/5.0/5.5 | ||||
| /6.0/6.5 | ||||
| Solid : 4.0/4.5/5.0/5.5/ | ||||
| 6.0/6.5/7.0 | ||||
| Cement : 4.5/5.0/5.5 | ||||
| /6.0 /6.5 | ||||
| Angled : 4.5/5.0/5.5 | ||||
| /6.0 | ||||
| Temporary Abutment : | ||||
| 4.0/4.5 | ||||
| Multi-unit Abutment | ||||
| _Straight : 4.8 | ||||
| _Angled : 4.7/5.13 | ||||
| FreeMilling : 4.5/5.0 | ||||
| /5.5/6.0/6.5 | Rigid : | |||
| 4.0/4.6/5.0/6.0 | ||||
| /7.0/8.0 | ||||
| Transfer : | ||||
| 4.0/4.6/5.0/ | ||||
| 6.0/7.0/8.0 | ||||
| Angled : 4.0/4.3/4.5/ | ||||
| 4.8/5.5/6.0 | ||||
| Temporary : 4.0/4.3/ | ||||
| 4.5 | ||||
| Convertible : 3.5/4.0/ | ||||
| 4.8/5.5/6.0 | ||||
| Freeform : 4.0/5.5 | ||||
| /7.0 | Multi Angle : - | Healing : | ||
| 4.0/4.5/5.0/6. | ||||
| 0/7.0/8.0 | ||||
| G/H Length (mm) | Healing : - | |||
| Solid : 1.0/1.5/2.0/2.5/ | ||||
| 3.0/3.5/4.0/4.5/5.0 | ||||
| Cement: 1.0/1.5/2.0/ | ||||
| 2.5/3.0/3.5/4.0/4.5/5.0 | ||||
| Angled : 2.0/3.0/4.0 | ||||
| Temporary: 1.0/3.0 | ||||
| Multi-unit Abutment | ||||
| Straight: 1.5/2.5/3.5/ | ||||
| 4.5 | ||||
| Angled : 2.5/3.5/.5 | ||||
| FreeMilling: 1.0/2.0/3.0 | Rigid : | |||
| 0.5/1.0/2.0/2.5/ | ||||
| 3.0/4.0/5.0 | ||||
| Transfer : | ||||
| 0.5/1.0/2.0/ | ||||
| 2.5/3.0/4.0/5.0 | ||||
| Angled : 0.5/1.0/2.0/ | ||||
| 2.5 / 3.0 / 4.0 | ||||
| Temporary: 1.0/2.0/ | ||||
| 3.0/4.0 | ||||
| Convertible: 0.5/1.0 | ||||
| /2.0/2.5/3.0/4.0/5.0/6.0 | ||||
| Freeform: 0.5/1.0 | ||||
| /1.5/2.0/2.5/3.0/4.0/5.0 | Multi Angle : - | Healing : | ||
| 3.0/4.0/5.0/7.0 | ||||
| Post Length (mm) | Healing : - | |||
| Solid: 4.0/5.5/7.0 | ||||
| Cement: 4.0/5.5/7.0 | ||||
| Angled: 7.5/8.0 | ||||
| Temporary : - | ||||
| Multi-unit Abutment | ||||
| Straight : 2.2 | ||||
| Angled : - | ||||
| FreeMilling: 10.0/11.0/12.0 | Rigid : 4.0/5.5/7.0 | |||
| Transfer : 4.0/5.5/7.0/8.0 | ||||
| Angled : - | ||||
| Temporary : - | ||||
| Convertible : - | ||||
| Freeform :- | Multi Angle:- | Healing: - | ||
| Angle(°) | Angled : 15°/25° | |||
| Multi-unit_Angled : | ||||
| 17°/30° | Angled : 17° | Multi Angel : | ||
| 17°/30° | - | |||
| Material of Abutment | Titanium Alloy | |||
| (ASTM F 136) : | ||||
| Healing, Solid, | ||||
| Cement, Multi-unit | ||||
| Pure Titanium Gr. 4 | ||||
| (ASTMF67-06) : | ||||
| Angled, Temporary, | ||||
| FreeMilling | Titanium Alloy | |||
| (ASTM F 136) : | ||||
| Rigid, Transfer, | ||||
| Angled, Convertible, | ||||
| Freeform | ||||
| Pure Titanium Gr. 4 | ||||
| (ASTMF67-06) : | ||||
| Temporary | Titanium | |||
| Alloy (ASTM | ||||
| F 136) : | Pure Titanium | |||
| Gr.4 | ||||
| (ASTMF67-06) | ||||
| Surface | Machine or TiN | Machine or TiN | Machine | Machine |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile | Radiation |
| Sterile | ||||
| Technological Characteristics | IH Prosthetic System is similar to predicate devices such as shape, structure, dimension and material. but it has different characteristics for each abutment. | |||
| 1.Material | ||||
| IH Prosthetic System | Predicate device | |||
| Healing | ||||
| Titanium Alloy | Pure Titanium Gr.4 | |||
| Angled | ||||
| Pure Titanium Gr.4 | Titanium Alloy | |||
| FreeMilling | ||||
| Pure Titanium Gr.4 | Titanium Alloy | |||
| 2.Shape (TiN Coating area) | ||||
| IH Prosthetic System | Predicate device |
7
8
9
10
| FreeMilling | Non Coating | Only Gingiva (Middle) |
|---|---|---|
| 3.Shape (Post Angle) | ||
| IH Prosthetic System | Predicate device | |
| Angled | 15° / 25° | 17° |
| 4.Sterilization | ||
| IH Prosthetic System | Predicate device | |
| Healing | Non-Sterile | Radiation Sterile |
| others | Non-Sterile | Non-Sterile |
Substantial Equivalence Review:
IH2 SLA Fixture has same material, machining, surface treatment, and indication for use and similar design and technological characteristics as the predicate device. IH Prosthetic System has same indication for use and manufacturing process including raw material, machining, cleaning and surface treatment and similar design and technological characteristics as the predicate device.
IH Implant System has been subjected to performance and product validations prior to release. Testing including biocompatibility has been performed to ensure the devices comply with the applicable International and US regulations.
The differences between the subject device and predicate devices are detailed shape and detailed dimension of diameter and length.
Any differences between the subject device and predicate devices do not raise new types of substantially equivalent issues.
| | | IH Implant
System | Predicate
Device | Ref. |
|-----------------------------------|------------------------------|----------------------|----------------------|---------------------------|
| Biocompatibility
(Fixture) | Cytotoxicity | OK | OK | - |
| | Sensitization | OK | OK | - |
| | Intracutaneous
Reactivity | OK | OK | - |
| | Acute Systemic | OK | OK | - |
| | Implantation | OK | OK | - |
| | Genotoxicity | OK | OK | - |
| Biocompatibility
(Prosthetic) | Cytotoxicity : | OK | OK | - |
| | Sensitization : | OK | OK | - |
| | Irritation | OK | OK | - |
| | Acute Systemic | OK | OK | - |
| | Genotoxicity | OK | OK | - |
| Roughness of SLA Surface (Ra) | | 2.861±0.262 μm | 2.5~3.0 μm | Osstem product
Catalog |
| Sterilization Validation | | VDmax 25
SAL 10-6 | VDmax 25
SAL 10-6 | - |
| Packaging Validation (Shelf life) | | 5years | 8years | - |
Summary of non-clinical testing:
11
K153521
Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations.
Fatigue testing for IH2 SLA Fixture and IH 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 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario. The results are in compliance with it and were similar to previously cleared predicate devices.
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act.21 CFR Part 807and based on the information provided in this premarket notification Sewon Medix Inc. Therefore, the IH Implant System is substantially equivalent to the predicate device as described herein.