(320 days)
No
The device description focuses on the physical components and materials of a dental implant system, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are non-clinical and do not involve data analysis typical of AI/ML applications.
No.
This device is intended to provide support for prosthetic devices and restore chewing function, which are mechanical and restorative actions, not directly therapeutic in nature according to the provided text.
No
The device is an implant system used to provide support for prosthetic devices and restore chewing function. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium metal and titanium alloy intended for surgical implantation, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The IU Implant System is a dental implant intended to be surgically placed in the bone of the jaw to support prosthetic devices and restore chewing function. It is a physical implant, not a device that analyzes biological samples.
The information provided clearly describes a surgically implanted device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The IU Implant System 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, and to restore the patient's chewing function.
Product codes
DZE, NHA
Device Description
The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment).
The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches
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
No clinical data were included in this submission.
Key Metrics
Not Found
Predicate Device(s)
K123155, K160965, K123988, K141457, K160828
Reference Device(s)
K160965, K123988, K141457, K160828
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 contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and 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" in blue, and the word "ADMINISTRATION" in a smaller font below. The logos are placed side-by-side.
WARANTEC Company, Limited % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K172345
Trade/Device Name: IU Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 21, 2018 Received: May 24, 2018
Dear Peter Chung:
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.
June 18, 2018
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); good manufacturing practice requirements as set forth in 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172345
Device Name IU Implant System
Indications for Use (Describe)
The IU Implant System 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, and to restore the patient's chewing function.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
510(k) Summary [as required by 807.92(c)]
I. SUBMITTER
- a) Company: WARANTEC Co., Ltd.
- b) Address: #411, #412, 474, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229, Korea
- Tel : +82-31-778-6328 c)
- Fax : +82-70-4324-6328 d)
- President of Company: Mr. Dong-Hwa Jang e)
- f) Contact Person : Peter Chung, 412-687-3976
- Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA g)
- Date Prepared: June 16, 2018 h)
II. DEVICE
- IU Implant System a) Trade Name :
- Common Name : Endosseous Dental Implant System b)
- c) Classification Name : implant, endosseous, root-form
- Product Code : DZE (primary), NHA (secondary) d)
- Regulation Number : 872.3640 e)
- f) Class of device : Class II
- Panel : Dental g)
III.PREDICATE DEVICE
- Primary Predicate Device: a) Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155
- Reference Device: b) SuperLine / DENTIUM CO., LTD. / K160965 AnyOne 100 Internal Implant System / MegaGenImplant Co., Ltd. / K123988 Dentium Implantium® & SuperLine® Prosthetics / DENTIUM CO., LTD. / K141457 Dentium Implantium & SuperLine Prosthetics / DENTIUM CO., LTD. / K160828
IV. DEVICE DESCRIPTION
The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment).
The IU Implant System is a dental implant made of titanium metal intended to be
5
surgically placed in the bone of the upper or lower jaw arches.
There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.
V. INDICATIONS FOR USE
The IU Implant System 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, and to restore the patient's chewing function.
VI. SUBSTANIAL EQUIVALNECE COMPARISON
The IU Implant System is similar designs and dimensions, and has the same material, intended use, surface treatment and technological characteristics as the identified primary predicate device (K123155) and reference devices (K160965/K123988/ K141457). When compared with predicate device, no new questions of substantial equivalence have been raised for the IU Implant System.
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K160965 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co., Ltd. |
| Common Name | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System | Endosseous Dental Implant System |
| Trade Name | IU Implant System | Luna Dental Implant System | SuperLine | AnyOneTM Internal Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | DZE | DZE | DZE | DZE |
| Indications for Use/
Intended Use | The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to | The Luna Dental Implant System is intended to be surgically placed in the bone of the upper or | SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or | The AnyOneTM Internal Implant System is intended to be surgically placed in the maxillary or |
| | provide support for | lower jaw arches to | lower jaw to provide | mandibular molar |
| | prosthetic devices, | provide support for | support for prosthetic | areas for the purpose |
| | such as artificial teeth, | prosthetic devices, | devices, such as | providing prosthetic |
| | and to restore the | such as artificial teeth, | artificial teeth, in order | support for dental |
| | patient's chewing | and to restore the | to restore the patient's | restorations (Crown, |
| | function. | patient's chewing | chewing function. | bridges, and |
| | | function. | SuperLine is indicated | overdentures) in |
| | | | also for immediate | partially or fully |
| | | | loading when good | edentulous individuals. |
| | | | primary stability is | It is used to restore a |
| | | | achieved and with | patient's chewing |
| | | | appropriate occlusal | function. Smaller |
| | | | loading. | implants (less than |
| | | | | 06.0 mm) are |
| | | | | dedicated for |
| | | | | immediate loading |
| | | | | when good primary |
| | | | | stability is achieved |
| | | | | and with appropriate |
| | | | | occlusal loading. |
| | | | | Larger implants are |
| | | | | dedicated for the molar |
| | | | | region and are |
| | | | | indicated for delayed |
| | | | | loading. |
| Implant design | Root-form endosseous | Implant, Endosseous, | Root-form endosseous | Root-form endosseous |
| | dental implants | Root-Form | dental implants | dental implants |
| Shape | a)
b) | | | |
| Connection | 2.1, 2.5 Internal Hex | 2.1, 2.5 Internal Hex | Internal Hex | Internal Hex |
| Diameter of fixture | a) 3.6, 4.1, 4.6, 5.1, | 3.7, 4.2 – 5.7 mm | 3.6, 4.0, 4.4, 4.9, 6.0, | Internal type |
| | 5.6, 6.1 mm | | 7.0 mm | 3.9, 4.3, 5.3, 6.3, 7.3 |
| | b) 4.3, 4.8, 5.3, 6.3 | | | mm (for normal |
| | mm | | | thread) |
| | | | | 4.8, 5.8, 6.8, 7.8, 8.3 |
| | | | | mm (for deep thread) |
| | | | | 4.8, 5.3, 6.3, 7.3 mm |
| | | | | (for special length) |
| Length of fixture | a) 7.5, 8.5, 10.0, 11.5, | 8.5 — 15.0 mm | 7.0, 8.0, 10.0, 12.0, | Internal type |
| | 13.0 mm | | 14.0 mm | 7.0, 8.0, 9.5, 11.0, |
| | (cf. 3.6 mm diameter | | | 12.5, 14.5 mm (for |
| | does not include a 7.5 | | | normal and deep |
| | mm length.) | | | thread) |
| | b) 7.0, 8.5, 10.0, 11.5, | | | 7.0 mm (for special |
| | 13.0 mm | | | length) |
| | (cf. 6.3 mm diameter | | | |
| | does not include a 13.0 | | | |
| | mm length.) | | | |
| Material | Pure titanium (ASTM
F67) | Pure titanium (ASTM
F67) | Pure titanium (ASTM
F67) | Pure titanium (ASTM
F67) |
| Physical testing
performed | Not tested/no
angulation submitted
for clearance. | Test according to ISO
14801 | Test according to ISO
14801 | Test according to ISO
14801 |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 |
| Surface treatment | S.L.A | S.L.A | S.L.A | S.L.A |
| Sterilization method | Gamma radiation | Gamma radiation | Gamma radiation | Gamma sterilization |
| Shelf-life | 7years | - | 8years | - |
Table 1 - Comparison of Endosseous Implant Characteristics
6
7
Table 2 - Comparison of Endosseous Abutments Characteristics
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K141457 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST
Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co.,
Ltd. |
| Common Name | Endosseous Dental
Implant System | Endosseous Dental
Implant System | Endosseous Dental
Implant System | Endosseous Dental
Implant System |
| Trade Name | IU Implant System | Luna Dental Implant
System | Dentium Implantium®
& SuperLine®
Prosthetics | AnyOne™ Internal
Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA | NHA | NHA |
| Indications for Use | The IU Implant
System 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,
and to restore the
patient's chewing
function. | The Luna Dental
Implant System 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,
and to restore the
patient's chewing
function. | Dentium Implantium®
& SuperLine®
Prosthetics are
intended for use as an
aid in prosthetic
rehabilitation. | The AnyOne ™
Internal Implant
System is intended to
be surgically placed in
the maxillary or
mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous individuals.
It is used to restore a
patient's chewing
function. Smaller |
8
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172345 | K123155 | K141457 | K123988
implants (less than
06.0 mm) are
dedicated for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading.
Larger implants are
dedicated for the molar
region and are
indicated for delayed
loading. |
| Cover Screw | | | | |
| Shape | Image: Cover Screw Shape 1 | Image: Cover Screw Shape 2 | Image: Cover Screw Shape 3 | Image: Cover Screw Shape 4 |
| Material | Pure titanium (ASTM
F67) | Pure titanium (ASTM
F67) | Ti-6Al-4V-ELI
(ASTM F136) | CP4 Titanium (ASTM
F67) |
| Diameter | 2.82, 3.32 mm | - | 3.6 mm | - |
| Abutment Screw | | | | |
| Shape | Image: Abutment Screw Shape 1 | Image: Abutment Screw Shape 2 | Image: Abutment Screw Shape 3 | Image: Abutment Screw Shape 4 |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Ti-6Al-4V-ELI |
| Diameter | 2.2 mm | - | 1.8 ~ 2.3 mm | 3.8 ~ 10.0 mm |
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| Manufacturer | WARANTEC Co., Ltd. | SHINHUNG MST
Co., Ltd. | DENTIUM CO., LTD. | MegaGenImplant Co.,
Ltd. |
| Common Name | Endosseous Dental
Implant System | Endosseous Dental
Implant System | Endosseous Dental
Implant System | Endosseous Dental
Implant System |
| Trade Name | IU Implant System | Luna Dental Implant
System | Dentium Implantium®
& SuperLine®
Prosthetics | AnyOneTM Internal
Implant System |
| Device class | Class II | Class II | Class II | Class II |
| Product Code(s) | NHA | NHA | NHA | NHA |
| Indications for Use | The IU Implant
System is intended to
be surgically placed in | The Luna Dental
Implant System is
intended to be | Dentium Implantium®
& SuperLine®
Prosthetics are | The AnyOne TM
Internal Implant
System is intended to |
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| | the bone of the upper
or lower jaw arches to
provide support for
prosthetic devices,
such as artificial teeth,
and to restore the
patient's chewing
function. | surgically placed in the
bone of the upper or
lower jaw arches to
provide support for
prosthetic devices,
such as artificial teeth,
and to restore the
patient's chewing
function. | intended for use as an
aid in prosthetic
rehabilitation. | be surgically placed in
the maxillary or
mandibular molar
areas for the purpose
providing prosthetic
support for dental
restorations (Crown,
bridges, and
overdentures) in
partially or fully
edentulous individuals.
It is used to restore a
patient's chewing
function. Smaller
implants (less than
06.0 mm) are
dedicated for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading.
Larger implants are
dedicated for the molar
region and are
indicated for delayed
loading. |
| Temporary Abutment | | | | |
| Shape | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: Ti-6A1-4V-ELI |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6A1-4V-ELI |
| Diameter | 3.9 mm | 4.0 ~ 6.0 mm | 4.5 mm | 3.8 ~ 10.0 mm |
| Two Piece Abutment | | | | |
| Shape | Image: (Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) | Image: (Hex) (Non-Hex) |
| | Subject Device | Primary Predicate
Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| | (Hex) (Non-Hex) | | | |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6Al-4V-ELI |
| Diameter | 3.8, 4.5, 5.5 mm
3.95, 4.95, 5.95 mm | 4.0 ~ 6.0 mm | 4.5, 5.5, 6.5 mm | 3.8 ~ 10.0 mm |
| Solid Abutment | | | | |
| Shape | Image: Solid Abutment Shape Subject Device | Image: Solid Abutment Shape Primary Predicate Device | Image: Solid Abutment Shape Reference Device | Image: Solid Abutment Shape Reference Device |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6Al-4V-ELI |
| Diameter | 3.8, 4.95, 5.5 mm
3.95, 4.95, 5.95 mm | 4.0 ~ 6.0 mm | 4.5, 5.5, 6.5 mm | 3.8 ~ 10.0 mm |
| Healing Abutment | | | | |
| Shape | Image: Healing Abutment Shape Subject Device | Image: Healing Abutment Shape Primary Predicate Device | Image: Healing Abutment Shape Reference Device | Image: Healing Abutment Shape Reference Device |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6Al-4V-ELI |
| Diameter | 3.95, 4.95, 5.95 mm | 4.0 ~ 6.0 mm | 4.0, 4.5, 5.5, 6.5 mm | 3.8 ~ 10.0 mm |
| Height | 9.0, 10.0, 11.0, 12.0,
13.0 14.0 mm | 8.5 ~ 15.0 mm | 8.214.6mm | 7.7 ~ 18.7 mm |6.0 mm | 3.3, 3.5 mm | 3.8 ~ 10.0 mm |
| Ball Abutment | | | | |
| Shape | Image: Ball Abutment Shape Subject Device | Image: Ball Abutment Shape Primary Predicate Device | Image: Ball Abutment Shape Reference Device | - |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6Al-4V-ELI |
| Diameter | 4.3 mm | 4.0
| Multi Abutment | | | | |
| Shape | Image: Multi Abutment Shape Subject Device | Image: Multi Abutment Shape Primary Predicate Device | Image: Multi Abutment Shape Reference Device | Image: Multi Abutment Shape Reference Device |
| | Subject Device | Primary Predicate Device | Reference Device | Reference Device |
| 510(k) Number | K172345 | K123155 | K160828 | K123988 |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Pure Titanium Grade 5
(ASTM F67) | Ti-6Al-4V-ELI |
| Diameter | 4.95 mm | 4.0 ~ 6.0 mm | 4.5, 5.5 mm | 3.8 ~ 10.0 mm |
| Retained Abutment | | | | |
| Shape | Image: Retained Abutment | - | Image: Retained Abutment | - |
| Material | Titanium alloy (ASTM
F136) | Titanium alloy (ASTM
F136) | Ti-6A1-4V-ELI
(ASTM F136) | Ti-6A1-4V-ELI
(ASTM F136) |
| Diameter | 4.3 mm | 4.0 ~ 6.0 mm | 3.7mm | 3.8 ~ 10.0 mm |
| Height | 8.4, 8.4, 9.4, 9.5, 10.4,
10.5, 11.4, 11.5, 12.4,
12.5, 13.4, 13.5 mm | 8.5 ~ 15.0 mm | 7.7~12.1mm | 7.7 ~ 18.7 mm |
| Physical testing
performed | Not tested/no
angulation submitted
for clearance. | Test according to ISO
14801 | Test according to ISO
14801 | Test according to ISO
14801 |
| Biocompatibility | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 | Biocompatible
according to ISO
10993-1 |
| Sterilization method | Non-sterile (Steam
sterilization prior to
use) | Non-sterile (Steam
sterilization prior to
use) | Non-sterile (Steam
sterilization prior to
use) | Non-sterile (Steam
sterilization prior to
use) |
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10
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VII. NON-CLINICAL TEST DATA
The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate device. This testing included:
Biocompatibility testing
The biocompatibility evaluation for the IU Implant System was conducted in accordance with the International Standard ISO 7405:2008, "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry", ISO 10993-1:2009/AC:2010, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" as recognized by FDA.
- Cytotoxicity (Elusion) -
- Sensitization -
- -Oral irritation
- -Systemic Toxicity (acute)
- Genotoxicity -
- Implantation -
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- -Endotoxin Test (LAL test)
The USP test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 5 EU/mL. We referenced the USP 39 to device on the endotoxin limit which is 5 EU/mL.
Sterilization Testing
Sterilization validating testing has been performed in accordance with ISO 11137-1:2006/Amd.1:2013, ISO 11137-2:2013 and ISO 11137-3:2006 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
Shelf Life Testing
For the subject devices provided sterile, accelerated aging shelf life testing was conducted according to ASTM F1980; real time testing is being conducted to support accelerated aging results.
Risk Analysis
Risk analysis for IU Implant System was conducted in accordance with ISO 14971, Medical Devices: Application of Risk Analysis, for medical devices. It was determined by IU Implant System that all risks associated with IU Implant System were acceptable and as low as reasonably possible.
No clinical data were included in this submission.
VIII. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WARANTEC Co., Ltd. concludes that the SHINHUNG MST Co., Ltd., DENTIUM CO., LTD., and MegaGenImplant Co., Ltd. is substantially equivalent to the predicate devices as described herein.