(171 days)
No
The summary describes a standard dental implant system with various components and surface treatments. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on non-clinical tests and sterilization validation, not AI/ML performance metrics.
No
The device is described as an endosseous dental implant system intended to replace missing teeth and restore chewing function, which is a restorative purpose, not a therapeutic one. It does not treat or cure a disease or condition.
No
Explanation: The device is described as an "endosseous dental implant" intended to "replace missing teeth to restore chewing function." Its purpose is to physically restore a lost function, not to identify or diagnose a condition.
No
The device description clearly outlines physical components made of materials like Ti-6AL-4V Eli, including dental implants, abutments, and screws. It also details surface treatments and packaging, indicating a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a dental implant system intended to be surgically placed in the jawbone to replace missing teeth and restore chewing function. It is a physical device implanted into the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical and structural.
Therefore, based on the provided information, the IBS Implant System is a medical device, specifically a dental implant system, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant 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 (comma separated list FDA assigned to the subject device)
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 is consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. 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 RBM (Resorbable Blasted media) to increase junction strength by increasing the area of bone-implant interface.
There are 2 types of fixtures in this system, NR Fix and Magic FC. The NR Fix has diameters in 3.5mm and lengths in 9, 10, 11, 12, 13, 14 mm. The Magic FC has diameters in 4. 4.5. 5.0. 5.5. 6.0. 6.5mm and lengths in 7. 9. 11, 13. 15 mm.
The contained various abutments and accessories in the system are Magic Screw retained type Abutment & protect cap, Healing Abutment, Angled Abutment (hexa, non hexa), Pair Abutment (non hexa), Solid Abutment & Solid abutment cap, Magic abutcoping (transfer type, pick up type), Multiunit abutment, UCLA abutment.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use. But healing abutment is supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2009 and surface treatment analysis were used to support the decision of substantial equivalence. Fatigue test was performed under the worst case scenario in accordance with ISO 14801:2007.
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 consists of a stylized eagle or bird symbol, with three profiles facing right, representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2016
InnoBioSurg Co., Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K153350
Trade/Device Name: IBS Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 1, 2016 Received: April 8, 2016
Dear Ms. 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.
1
Page 2 - Ms. April Lee
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 devicerelated 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.
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,
Tina Kiang
-s
for Erin I. Keith, M.S. 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 shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, dark blue font, followed by the word "implant" in a smaller, dark blue font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, light yellow font. The logo also includes a stylized square with a yellow accent in the upper left corner.
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro Tel. 82- 42-933-2879 / Fax. 8
Indication for Use
K153350 510(K) Number (if known):
Device Name: IBS Implant System
Indication for Use:
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant 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.
Prescription Use
AND/OR
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
Image /page/3/Picture/1 description: The image shows the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features the letters "IBS" in a bold, dark blue font, with a yellow square in the upper left corner of the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "InnoBiosurg Co., Ltd" in a smaller, light yellow font.
Tel. 82- 42-933-2879 / Fax. 82-42-933-288
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
- 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: 5/2/2016
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 is consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. 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 RBM (Resorbable Blasted media) to increase junction strength by increasing the area of bone-implant interface.
There are 2 types of fixtures in this system, NR Fix and Magic FC. The NR Fix has diameters in 3.5mm and lengths in 9, 10, 11, 12, 13, 14 mm. The Magic FC has diameters in 4. 4.5. 5.0. 5.5. 6.0. 6.5mm and lengths in 7. 9. 11, 13. 15 mm.
The contained various abutments and accessories in the system are Magic Screw retained type Abutment & protect cap, Healing Abutment, Angled Abutment (hexa, non hexa), Pair Abutment (non hexa), Solid Abutment & Solid abutment cap, Magic abutcoping (transfer type, pick up type), Multiunit abutment, UCLA abutment.
Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use. But healing abutment is supplied sterile.
4
Image /page/4/Picture/0 description: The image contains the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features a stylized "i" and "G" in a blue square, followed by the text "IBS" in bold, blue letters. To the right of "IBS" is the word "implant" in a smaller, blue font, and below that is "InnoBiosurg Co.,Ltd" in a smaller, lighter font.
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Kore
00
The purpose of this submission is to add new fixtures (NR Fix, Magic FC), magic screw, healing abutment, angled abutment, pair abutment (non-hexa), screw retained type abutment and solid abutment cap, magic abutcoping, UCLA abutment, and Multi unit abutment. Also, the shelf life of the products is changed from 2 years to 5 years.
Indication for Use
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant 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.
Materials:
The dental implants are fabricated fromTi-6AL-4V Eli (Conforming to ASTM Standard F-136).
Non-Clinical Data:
Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2009 and surface treatment analysis were used to support the decision of substantial equivalence. Fatigue test was performed under the worst case scenario in accordance with ISO 14801:2007.
5
Image /page/5/Picture/0 description: The image is a logo for IBS implant. The logo consists of the letters "IBS" in a bold, sans-serif font, with the "I" having a yellow square in the upper left corner. To the right of "IBS" is the word "implant" in a smaller, sans-serif font. Below "implant" is the text "Innobiosurg Co.,Ltd" in an even smaller, sans-serif font.
Comparison to Predicate Devices:
Comparison of the technological characteristics of the subject device and predicate devices is shown in the Table of Substantial Equivalence below.
- Fixture
- K140806, IBS Implant System by InnoBioSurg Co., Ltd. .
| Subject Device | Predicate Device | |
|---|---|---|
| Product Name | IBS Implant System | IBS Implant System |
| 510(k) | ||
| Product code | ||
| Class | NA | |
| DZE | ||
| II | K140806 | |
| DZE | ||
| II | ||
| Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. |
| Indication for | ||
| use | The IBS Implant System is intended to | |
| replace missing teeth to restore chewing | ||
| function. The IBS Implant System 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. | The IBS Implant System is intended to | |
| replace missing teeth to restore chewing | ||
| function. | ||
| The IBS Implant System 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 | ||
| and not for immediate loading. This system | ||
| is intended for delayed loading. | ||
| Design | Image: NR Fix | |
| Image: Magic FC | Image of a screw | |
| Composition of | ||
| Material | Titanium Alloy | |
| Ti-6Al-4V Eli | ||
| ASTM F136 | Titanium Alloy | |
| Ti-6Al-4V Eli | ||
| ASTM F136 | ||
| Fixture Type | Submerged | Submerged |
| Endosseous | ||
| Implant | Tapered, macro threads | Tapered, macro and |
| micro threads | ||
| Components | Various abutments and | |
| accessories | Various abutments and accessories | |
| Range of | ||
| Diameters (mm) | NR Fix : 3.5mm | |
| Magic Fc : 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | ||
| mm | 3.8, 4.3, 4.8, 5.3, 5.8, 6.3 mm | |
| Range of | ||
| Lengths (mm) | NR Fix : 9, 10, 11, 12, 13, 14mm | |
| Magic FC : 7, 9, 11, 13, 15mm | 7 mm – 15 mm | |
| Modified | ||
| Surface | R.B.M. | R.B.M. |
| Surgical | ||
| Technique | 1 stage and 2 stage, self tapping | 1 stage and 2 stage, self tapping |
| Gamma | ||
| Sterilization | Yes | Yes |
6
Image /page/6/Picture/0 description: The image shows the logo for IBS Implant InnoBiosurg Co., Ltd. The logo features the letters "IBS" in a bold, dark blue font, with a yellow square in the upper left corner of the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font, and below that is the text "InnoBiosurg Co., Ltd" in a smaller, light yellow font.
InnoBioSurg
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
2) Abutments
- K140507, Hiossen Prosthetic System by Osstem Implant Co., Ltd. ●
- K123755, Multi Angled Abutment by Osstem Implant Co., Ltd. ●
- K111120, CSM Submerged-R Implant System by CSM Implant .
| Subject Device | Predicate devices | |||
|---|---|---|---|---|
| Hiossen Prosthetic System | Multi Angled Abutment | CSM Submerged-R Implant System | ||
| Manufacturer | Innobiosurg Co., Ltd | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | CSM Implant |
| Design | Image: pair angled solid | Image: Rigid Transfer Angled | Image: Multi Angle | |
| Image: Multiunit | ||||
| 510(k) No. | - | K140507 | K123755 | K111120 |
| Intended | ||||
| Use | IBS prosthetic | |||
| system is | ||||
| intended for use | ||||
| with a dental | ||||
| implant to | ||||
| provide support | ||||
| for prosthetic | ||||
| restorations such | ||||
| as crowns, | ||||
| bridges, or | ||||
| overdentures. | 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. | The CSM | |||
| Submerged-R | ||||
| implant system is | ||||
| especially | ||||
| designed for use in | ||||
| dental implant | ||||
| surgery. | ||||
| Structure | Internal Hex | External Hex | External Hex | Internal Hex |
| Connection | ||||
| Type | Internal Hex- | |||
| Connected | Screw & External Hex- | |||
| Connected | Screw & | |||
| External Hex- | ||||
| Connected | Internal Hex- | |||
| Connected | ||||
| Diameter (mm) | Solid:3.5/4.0/4.5/ | |||
| 5.0/5.5/6.0/6.5 | ||||
| Pair:4.0/4.5/5.0/5. | ||||
| 5/6.0/6.5 | ||||
| Angled:4.0/4.5/5. | ||||
| 0 | ||||
| UCLA:3.5/4/4.5/ | ||||
| 5/5.5 | ||||
| Multiunit:4.1/4.5/ | ||||
| 5.0/5.5/6.0/6.5 | ||||
| Screw retained | ||||
| type:3.5/4.0/4.5/5 | ||||
| .5/6.5 | 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 | Multi Angle : - | UCLA:4.5 | ||
| G/H Length | ||||
| (mm) | Solid:1.0/2.0/3.0/ | |||
| 4.0 | ||||
| Pair: | ||||
| 1.0/2.0/3.0/4.0 | ||||
| Angled: | ||||
| 1.0/2.0/3.0/4.0 | ||||
| UCLA: | ||||
| 1.0/2.0/3.0/4.0 | ||||
| Multiunit: | ||||
| 1.0/2.0/3.0/4.0/5. | 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 | Multi Angle : - | UCLA:0.75 | ||
| 0 | ||||
| Screw retained | ||||
| type:0.7/1.5/2.5/3 | ||||
| .5/4.5/5.5/6.5 | ||||
| Post Length | ||||
| (mm) | Solid:4.0/6.0/8.0 | |||
| Pair:6.0 | ||||
| Angled:0,1.0/2.0/ | ||||
| 3.0/4.0 | ||||
| UCLA:1.0/2.0/3.0 | ||||
| /4.0 | Rigid : 4.0/5.5/7.0 | |||
| Transfer : | ||||
| 4.0/5.5/7.0/8.0 | ||||
| Angled : - | Multi Angle : - | UCLA:12 | ||
| Angle(°) | Angled : 15°/ | |||
| 25°/30° | ||||
| Multi Angel : | ||||
| 17°/30° | Angled : 17° / 25° | Multi Angle : | ||
| 17°/30° | - | |||
| Material of | ||||
| Abutment | Titanium Alloy | |||
| (ASTM F 136) | ||||
| Polydiacetate: | ||||
| Cap, UCLA | ||||
| Titanium Gr4 | ||||
| (ASTM F67) : | ||||
| Multiunit | ||||
| abutment cap | Titanium Alloy (ASTM | |||
| F 136) : Rigid, | ||||
| Transfer, Angled, | ||||
| Convertible | Titanium Alloy | |||
| (ASTM F 136) : | P.O.M(UCLA) | |||
| Surface | Machine | Machine or TiN | Machine | Machine |
| Sterilization | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
7
Image /page/7/Picture/0 description: The image contains the logo for IBS implant. The logo consists of a blue square with a stylized white "iG" inside, followed by the text "IBS implant" in a bold, dark blue font. Below the word "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, lighter font.
InnoBioSurg Co., Ltd.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
11 Tel. 82-42-933-2879 / Fax. 82-42-933-2881
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
Tel. 82-42-933-2879 / Fax. 82-42-933-2881
8
Image /page/8/Picture/0 description: The image shows the logo for IBS implant. The logo consists of the letters "IBS" in a bold, dark blue font, with a yellow dot above the "I". To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "Innobiosurg Co.,Ltd" in a smaller, light yellow font.
44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
Tel. 82-42-933-2879 / Fax. 82-42-933-2881
Substantial Equivalence Discussion
The IBM Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium.
The subject and predicate devices are similar in indications, design, technology, functions, dimensions and materials.
The subject device and predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence. The differences between the subject device and predicate devices are slight differences in fixture's design and sizes. Differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate device.
9
Image /page/9/Picture/0 description: The image is a logo for IBS Implant. The logo features the letters "IBS" in a bold, dark blue font, with a stylized icon to the left of the letters. To the right of "IBS" is the word "implant" in a smaller, dark blue font. Below "implant" is the text "Innobiosurg Co., Ltd" in a smaller, lighter font.
InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 305-510, Korea
Conclusion
The IBS Implant System, 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 and its predicate are substantially equivalent.