(201 days)
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
No
The device is described as an endosseous dental implant system intended to replace missing teeth to restore chewing function, which addresses a physical function rather than treating or preventing a disease, injury, or condition.
No
The device description indicates it is a dental implant system used to replace missing teeth and restore chewing function, not to diagnose a condition.
No
The device description explicitly states it is made of materials like Ti 6AL 4V Eli and consists of dental fixtures, screws, and multiunit abutment cylinders, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "replace missing teeth to restore chewing function." This is a therapeutic and restorative function performed directly on the patient's body.
- Device Description: The device is described as "endosseous dental implants," which are surgically implanted devices.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly describes a surgically implanted dental device, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
Product codes
DZE, NHA
Device Description
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with SLA (sand-blasted, large-grit, acid-etched) by increasing the area of bone-implant interface. Fixtures and cover screw are packaged together and supplied sterile. Cylinders are used in conjunction with screw retained type Abutment to provide support for screw type final prosthesis, and for fabrication of custom abutment for screw retained restorations. The screw retained type is used for fabricating the single-unit prosthesis, and the multi-unit prosthesis. Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is an one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility tests according to ISO 10993-1, ISO 10993-10 and ISO 10993-10 and ISO 10993-11 ●
- . Endotoxin Test according to USP
Below tests were performed for predicate devices and leveraged for the subject device:
- Gamma Sterilization Validation Test according to ISO11137-1,-2 referenced in K153350
- End User Steam Sterilization Test according to AAMI TIR12:2010 referenced in K140806 ●
- Shelf life Validation Test according to ISO 11607-1, -2, and ASTM F1980-07 referenced in K153350
- Fatigue Test according to ISO 14801 referenced in K153350 ●
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Surface treatment analysis were performed to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2017
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K162099
Trade/Device Name: IBS Implant System II Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 10, 2017 Received: January 17, 2017
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
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
Indications for Use
510(k) Number (if known) K162099
Device Name IBS Implant System II
Indications for Use (Describe)
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
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
510(k) Summary
Submitter
InnoBioSurg Co., Ltd. Bo-reum Yoo 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027 Republic of Korea Email: bryoo@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881
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
Device Information
- Trade Name: IBS Implant System II
- 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: 02/14/2017
General Description
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.
The diameters and lengths of the IBS Implant System II are below:
- Fixture: NR Fix
| Diameter | Length |
|---|---|
| Ø3.5mm | 9 mm |
| 11 mm | |
| 13 mm | |
| Ø3.8 mm | 7 mm |
| 10 mm | |
| 11 mm | |
| 12 mm | |
| 13 mm | |
| 14 mm | |
| 15 mm |
4
2) Fixture: Magic FC
| Diameter | Length |
|---|---|
| Ø4.0 mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm | |
| Ø4.5 mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm | |
| Ø5.0mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm | |
| Ø5.5 mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm | |
| Ø6.0 mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm | |
| Ø6.5 mm | 7 mm |
| 9 mm | |
| 11 mm | |
| 13 mm | |
| 15 mm |
The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The subject device is compatible with the following abutments:
| K number | Compatible Abutments |
|---|---|
| K153350 | magic screw, healing abutment, angled abutment, pair abutment(non-hexa), screw retained |
| type abutment, solid abutment and solid abutment cap, magic abutcoping, UCLA abutment, | |
| and Multi unit abutment |
The surface of the system has been treated with SLA (sand-blasted, large-grit, acid-etched) by increasing the area of bone-implant interface.
Fixtures and cover screw are packaged together and supplied sterile. Cover Screw (HISC00) was cleared from K140806.
Cylinders are used in conjunction with screw retained type Abutment to provide support for screw type final prosthesis, and for fabrication of custom abutment for screw retained restorations.
The screw retained type is used for fabricating the single-unit prosthesis, and the multi-unit prosthesis.
5
3) Multiunit Ti Cylinder
| Diameter | Length | Remark |
|---|---|---|
| Ø3.5 mm | 12 mm | Hexa/Non-Hexa |
| Ø4.0 mm | ||
| Ø4.5 mm | ||
| Ø5.0 mm | ||
| Ø5.5 mm | ||
| Ø6.0 mm |
4) Multiunit Temporary Cylinder
| Diameter | Length | Remark |
|---|---|---|
| Ø3.5 mm | 12 mm | Hexa/Non-Hexa |
| Ø4.0 mm | ||
| Ø4.5 mm | ||
| Ø5.0 mm | ||
| Ø5.5 mm | ||
| Ø6.0 mm |
5) Multiunit Plastic Cylinder
| Diameter | Length | Remark |
|---|---|---|
| Ø3.5 mm | 12 mm | Hexa/Non-Hexa |
| Ø4.0 mm | ||
| Ø4.5 mm | ||
| Ø5.0 mm | ||
| Ø5.5 mm | ||
| Ø6.0 mm |
6) Magic Motion
Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is an one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.
| Product name | Diameter | Cuff | Length |
|---|---|---|---|
| Magic Motion | 3.9 mm | 1 mm | 9.65 mm |
| 2 mm | 10.65 mm | ||
| 3 mm | 11.65 mm | ||
| 4 mm | 12.65 mm | ||
| 5 mm | 13.65 mm | ||
| 6 mm | 14.65 mm | ||
| 7 mm | 15.65 mm | ||
| 8 mm | 16.65 mm |
Indication for Use
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
6
Materials:
The dental implants are fabricated from Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The abutments are fabricated from Ti 6AL 4V Eli and Poly Diacetate.
Non-Clinical Data:
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility tests according to ISO 10993-1, ISO 10993-10 and ISO 10993-10 and ISO 10993-11 ●
- . Endotoxin Test according to USP
Below tests were performed for predicate devices and leveraged for the subject device:
- Gamma Sterilization Validation Test according to ISO11137-1,-2 referenced in K153350
- End User Steam Sterilization Test according to AAMI TIR12:2010 referenced in K140806 ●
- Shelf life Validation Test according to ISO 11607-1, -2, and ASTM F1980-07 referenced in K153350
- Fatigue Test according to ISO 14801 referenced in K153350 ●
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Surface treatment analysis were performed to support the decision of substantial equivalence.
Comparison to Predicate Devices:
-
- Fixtures
- K153350, IBS Implant System by InnoBioSurg Co., Ltd. ●
- K140440, Noris Medical Dental Implants System by Noris Medical Ltd. .
| Subject device | Primary Predicate device | Reference Device | |
|---|---|---|---|
| Product | |||
| Name | IBS Implant System | ||
| II | IBS Implant System | Noris Medical Dental | |
| Implants System | |||
| 510(k) | |||
| Product code | |||
| Class | N/A | ||
| DZE | |||
| II | K153350 | ||
| DZE | |||
| II | K140440 | ||
| DZE | |||
| II | |||
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | Noris Medical Ltd. |
| Indication for | |||
| use | Identical to the | ||
| Predicate devices | Intended for use in partially or | ||
| fully edentulous mandibles and | |||
| maxillae, in support of single or | |||
| multiple-unit restorations | |||
| including; cement-retained, | Noris Medical Dental | ||
| Implants System is intended | |||
| to replace missing | |||
| tooth/teeth in either jaw for | |||
| supporting prosthetic | |||
| screw- retained, or overdenture | |||
| restorations, and terminal or | |||
| intermediate abutment support | |||
| for fixed bridgework. This | |||
| system is dedicated for one and | |||
| two stage surgical procedures | |||
| and not dedicated for | |||
| immediate loading. This system | |||
| is intended for delayed loading. | devices that may aid in | ||
| restoring the patients | |||
| chewing function. The | |||
| procedure can be | |||
| accomplished in a one-stage | |||
| or two-stage surgical | |||
| operation. All implants are | |||
| appropriate for immediate | |||
| loading when good primary | |||
| stability is achieved and | |||
| with appropriate occlusal | |||
| loading. | |||
| Design | Image: Implant | Image: Implant | |
| Composition | |||
| of Material | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| ASTM F136 | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| ASTM F136 | Titanium Alloy | ||
| Ti-6Al-4V Eli | |||
| ASTM F136 | |||
| Prosthetic | |||
| connection | Identical | Internal Hex | Internal Hex |
| Endosseous | |||
| Implant | Identical | Tapered, macro | |
| threads | Tapered, micro · macro | ||
| threads | |||
| Components | Identical | Various abutments and | |
| accessories | Various abutments and | ||
| accessories | |||
| Range of | |||
| Diameters | |||
| (mm) | Identical | NR Fix : 3.5, 3.8mm | |
| Magic Fc : 4.0, 4.5, 5.0, 5.5, | |||
| 6.0, 6.5 mm | 3.3, 3.75, 4.2, 5, 6mm | ||
| Range of | |||
| Lengths | |||
| (mm) | Identical | NR Fix : 9, 10, 11, 12, 13, | |
| 14mm | |||
| Magic FC : 7, 9, 11, 13, 15mm | 8, 10, 11.5, 13, 16mm | ||
| Modified | |||
| Surface | S.L.A | R.B.M. | S.L.A |
| Surgical | |||
| Technique | Identical | 1 stage and 2 stage, self tapping | 1 stage and 2 stage, self |
| tapping | |||
| Gamma | |||
| Sterilization | Identical | Yes | Yes |
7
8
2) Abutment
- K153350, IBS Implant System by InnoBioSurg Co., Ltd. .
- . K142813, Biogenesis Implant System-Kisses by Biogenesis Co., Ltd.
| | Subject Device | Primary Predicate | Reference
Predicate | Reference
Predicate |
|-----------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Innobiosurg Co., Ltd | Innobiosurg Co., Ltd | Biogenesis Co.,
Ltd | Innobiosurg Co.,
Ltd |
| Device Name | IBS Implant System
II | IBS Implant System | Biogensis Implant
System-Kisses | IBS Implant
System |
| 510(k) No. | N/A | K153350 | K142813 | K140806 |
| Design | Image: Cylinders | Image: Burn out (Plastic)Cylinder | Image: The Biogenesis Implant System | - |
| | Image: Magic Motion | - | - | |
| Indication
for use | Identical to the
Predicate devices | IBS Implant system
is intended for use
with a dental
implant to provide
support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | The Biogenesis
Implant System –
Kisses is indicated
for use in partially
or fully edentulous
mandibles and
maxillae, in
support of single
or multiple-unit
restorations
including; cement
retained, screw
retained, or
overdenture
restorations and
terminal or
intermediate
abutment support
for fixed
bridgework. The
Biogenesis
Implant System –
Kisses is for single
and two stage
surgical
procedures. It is | IBS Implant system
is intended for use
with a dental
implant to provide
support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. |
| | | | for delayed
loading. | |
| Connection
Type | Internal Hex-
Connected | Internal Hex-
Connected | | Internal Hex-
Connected |
| Diameters | Cylinders : 3.5, 4.0,
4.5, 5.0, 5.5, 6.0 mm
Magic Motion : 3.9
mm | 4.5, 5.5, 6.5mm | 3.0mm, 3.5mm | 4.0, 4.5, 5.0, 5.5,
6.0, 6.5mm |
| Lengths | Cylinders : 12mm | 14.8mm | | 10.6, 11.6, 12.6,
13.6, 14.6, 15.6mm |
| G/H Length
(mm) | Magic
Motion :1mm-8mm | 1mm-4mm | 0.5mm-7mm | 1mm-4mm |
| Angle(°) | No Angulation | No Angulation | No Angulation | No Angulation |
| Material | Titanium Alloy
Poly Diacetate | Titanium Alloy
Poly Diacetate | Titanium Alloy | Titanium Alloy |
| Surface | Machine | Machine | Anodizing
coloring - Gold
color (Entire
Body) | Machine |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
9
Substantial Equivalence Discussion
Similarities
The indications for use, material, general shape design, dimension, surface, connection to abutment method, application method and sterilization method between the IBS Implant System II and the predicate devices are similar.
Differences
1) Fixtures
The difference between the subject device and the primary predicate device is the surface treatment method of the fixture. The surface of the fixture of the primary predicate has been treated with RBM (Resorbable Blasted media) and the surface of the subject device has been treated with SLA (sand-blasted, large-grit, acid-etched). The reference predicate device, Noris Medical Dental Implants System (K140440) has the same surface treatment as the subject device.
2) Cylinders
Another difference is the dimension and design of the multiunit abutment cylinder. The range of the diameters of the subject device is 3.5 to 6.0mm and the length of the subject device is 12mm. The range of the diameters of the primary predicate device is 4.5 to 6.5mm and the length of the primary predicate device is 14.8mm. While the outer surface of the predicate device is smooth, the outer surface of the subject device is designed with grooves, which allow resin to stick well and thus make it easier to manufacture the frame of the teeth.
10
3) Magic Motions
The difference is the diameter size of the magic motion. The diameter of the subject device is 3.9mm and is a bit bigger than the predicate's which are 3.0 mm and 3.5mm.
Brief Discussion
The differences between the subject device and predicate device are the fixture's surface treatment, cylinders' design and dimension, and magic motions' diameter size. For the fixture's surface treatment, as we provided the SLA analysis information and the predicate, K140440 has the same surface treatment. According to the indication for use of the cylinder with appropriate diameter and length is used for hand-milling. Since the selection of an appropriate cylinder may reduce the milling time and deletion. the smaller diameter or the shorter length in comparison with the predicate device does not affect the substantial equivalence. An appropriate size of cylinder locked on the abutment may be used. Accordingly we can claim the substantially equivalence of the subject device to predicate device. For the magic motion's size, as the subject device's diameter is bigger than the predicate's. Any differences between the IBS Implant System II and predicate device do not raise questions. Accordingly we can claim the substantially equivalence of the IBS Implant System II to predicate device.
Conclusion
The IBS Implant System II. subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, IBS Implant System II and its predicates are substantially equivalent.