(411 days)
No
The summary describes a system of physical components (abutments, components, and screws) for dental prosthetic restoration and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a prosthetic system intended to provide support for prosthetic restorations, not to treat or cure a disease or condition.
No
The device is described as a prosthetic system intended to provide support for dental restorations, not to diagnose a condition.
No
The device description explicitly states it is "consisted of abutments, components and abutment screws," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for prosthetic restorations (crowns, bridges, over-dentures) with a dental implant. This is a mechanical function within the body.
- Device Description: The device consists of abutments, components, and abutment screws, which are physical parts used in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use as part of a dental restoration.
N/A
Intended Use / Indications for Use
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.
The ET US SS Prosthetic system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The ET US SS Prosthetic system is substantially equivalent in design, function and intended use to the Predicate Devices as above.
Quick Temporary Abutment
Description: Used temporary until final prosthesis is made to maintain esthetic appearance. Quick Temporary Abutment Set is consisted of Quick Temporary Abutment and Ti Screw.
Material: Titanium Alloy + Plastic (Polyetherethereketone)
Diameter (mm): 4, 4.5
Height (mm): 13.9, 14.3, 14.5, 14.6, 17.4, 17.8, 18.0, 18.1
Multi Abutment
Description: Used for edentulous mandible or maxilla. Usually use to make full denture. Screw Retained Restoration. Used in screw type prosthetics in multiple cases. Multi Abutment Set is consisted of Multi Abutment and Multi Abutment Carrier.
Material: Titanium Alloy (TiN Coating)
Diameter (mm): 4.8
Height (mm): 8.3, 8.7, 9.3 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7
Solid Abutment
Description: Used in producing ordinary cement-retained prosthetics. Solid Abutment Set is consisted of Solid Abutment and Solid Protect Cap.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 3.5, 4.3
Height (mm): 9.5, 9.8, 11, 11.3, 12.5, 12.8
Solid Protect Cap
Description: Used to protect Solid abutments in the oral cavity.
Material: Polymer (Polycarbonate)
Diameter (mm): 5.3, 6.02
Excellent Solid Abutment
Description: Used in producing cement-retained prosthetics. Excellent Solid Abutment Set is consisted of Excellent Solid Abutment and Solid Protect Cap.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 4.3, 5.29
Height (mm): 9.5, 9.7, 11, 11.2, 12.5, 12.7
Excellent Solid Protect Cap
Description: Used to protect Excellent Solid Abutments in the oral cavity.
Material: Polymer (Polycarbonate)
Diameter (mm): 5.3, 6.6
ComOcta Abutment
Description: Used for making general cement-type prosthesis. ComOcta Abutment is consisted of ComOcta Abutment and Ti Screw.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 4.3, 5.26
Height (mm): 6.53, 6.55, 6.88, 6.90, 8.03, 8.05, 8.38, 8.40, 9.53, 9.55, 9.88, 9.90
ComOcta Plus Abutment
Description: Used for making general cement-type prosthesis and used when there is deep gingiva or a fixture is to be deeply inserted. Gold coloring on gingiva region is for aesthetics. ComOcta Plus Abutment Set is consisted of ComOcta Plus Abutment and Ti Screw.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 4.8, 6.0
Height (mm): 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10
ComOcta Angled Abutment
Description: Used for prosthetic restoration and path adjustment of prosthesis in case of 15° and 20° axial angle. ComOcta Angled Abutment Set is consisted of ComOcta Angled Abutment and Ti Screw.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 3.75, 4.3
Height (mm): 5.5, 6.7
ComOcta Retraction Cap
Description: Used to protect ComOcta abutments in the oral cavity
Material: Polymer (PolyOxy Methylene)
Diameter (mm): 6.4, 7.7
Cover Screw
Description: Used to protect other substances from ingressing into the fixture after the sugical operation.
Material: Titanium (ASTM F 67)
Diameter (mm): 3.7, 4.3, 5.2, 5.3
Height (mm): 5.9
Healing Abutment
Description: Used to form the appropriate gingival shape after the second surgery.
Material: Titanium (ASTM F 67)
Diameter (mm): 4, 5, 6, 7
Height (mm): 7.9, 8.9, 9.9, 11.4, 12.9
Cemented Abutment
Description: Used for making general cement-type prosthesis.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 4.0, 4.1, 5.0, 5.1, 6.0, 7.0
Height (mm): 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 11.0
Ti Screw
Description: Used to connect abutment with fixture.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 2.3, 2.9, 3.2
Height (mm): 8.0, 8.2
US Multi Angled Abutment
Description: If a few number of fixture were implanted in mandibular bone for making full denture, some of fixture path should be leaned. In that case, US Multi Angled Abutment is used to adjust path of prosthesis in case of 17 and 30° axial angle. US Multi Angled Abutment Set is consisted of US Multi Angled Abutment, Ti Screw, and Abutment Carrier.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 3.4, 4.0, 4.1
Height (mm): 3.97, 3.98, 4.28, 4.77, 4.78, 5.28, 5.47, 6.28
Ti Screw
Description: Used to connect abutment with fixture.
Material: Titanium Alloy (ASTM F 136)
Diameter (mm): 2.2, 2.3
Height (mm): 4.9, 5.55
Esthetic-low Abutment
Description: Used in producing screw-retained aesthetic prosthetics. Structure producing prosthetics in cylinder after attaching abutment in the oral cavity. Esthetic-low Abutment Set is consisted of Esthetic-low Abutment and Esthetic-low Abutment Screw.
Material: Titanium (ASTM F67)
Diameter (mm): 4.8, 5.5
Height (mm): 2.1, 2.2, 3.0, 3.1, 4.0, 4.1, 5.0, 5.1
Esthetic-low Abutment Screw
Description: Used to connect Esthetic-low abutment with fixture.
Material: Titanium (ASTM F67)
Diameter (mm): 3.1, 3.6
Height (mm): 7.8, 7.9, 8.8, 8.9, 9.8, 9.9, 10.8, 10.9
Esthetic-low Temporary Cylinder
Description: Used in producing temporary prosthetics. Esthetic-low Temporary Cylinder is consisted of Esthetic-low Temporary Cylinder and Ti Screw.
Material: Titanium (ASTM F 67)
Diameter (mm): 4.8, 5.5
Height (mm): 12.0
O-ring Abutment
Description: Used in creating stud type overdenture prosthetics.
Material: Titanium Alloy
Diameter (mm): 5.0, 5.6
Height (mm): 2.0, 3.0, 4.0, 5.0, 6.0
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)
No clinical studies are submitted.
Nonclinical testing:
Biocompatibility: Material in use, manufacturing process, surface treatment, and sterilization method is same as the predicates, US System, OSSTEM IMPLANT CO., LTD., K062030; TS Implant System, OSSTEM IMPLANT CO., LTD., K121585; HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K100245; ET Prosthetic System, OSSTEM IMPLANT CO., LTD., K130662; SS System, OSSTEM IMPLANT CO., LTD., K062051; US, SS, GS System, OSSTEM IMPLANT CO., LTD., K073247; NP Cast Abutment System, OSSTEM IMPLANT CO., LTD., K121843; HU, HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K081575; and Multi Angled Abutment with carrier, OSSTEM IMPLANT CO., LTD., K132067. Therefore, no additional testing is required to support the biological safety of the subject devices.
Sterilization Validation: For Cover Screw and Healing Abutment, the test result is considered to be substantial equivalent to that of the predicate, GSII RBM Fixture of GS Fixture System, OSSTEM IMPLANT CO., LTD., K072896; therefore, no additional testing is required. Except for them, the rest are non-sterile devices and are conducted of steam sterilization validation according to ISO 17665-1:2006.
Fatigue Test: Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario.
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.
K062030, K121843, K062051, K073247, K100245, K132067
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.
K121585, K100245, K130662, K062051, K073247, K121843, K081575, K132067
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2017
OSSTEM Implant Co., Ltd. % David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K160670
Trade/Device Name: ET US SS Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 12, 2017 Received: April 12, 2017
Dear David Kim:
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.
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 shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" in orange to the left of the company name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com.
Indications for Use Statement
_K160670 510(k) Number
Device Name: ET US SS Prosthetic system
Indication for use:
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
Prescription Use X (Per 21CFR801 Subpart D) OR
Over-The-Counter Use (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
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
Date: April 25, 2017
- Company and Correspondent making the submission:
| - Submitter's Name: | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address: | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, |
| Busan, Republic of Korea | |
| - Contact: | Mr. Hee Kwon Son |
| - Phone: | +82 51 850 2575 |
| - Correspondent's Name: | HIOSSEN Inc. |
| - Address: | 85 Ben Fairless Dr. Fairless Hills, PA 19030 |
| - Contact: | DAVID KIM |
| - Phone: | 267 759 7031 |
-
- Device:
| Trade or (Proprietary) Name: | ET US SS Prosthetic system |
|---|---|
| Common or Usual Name: | Dental Abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21CFR872.3630 |
| Device Classification: | Class II |
| Product Code: | NHA |
-
- Predicate Device:
Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD
- Predicate Device:
Reference Predicates
K121585 TS Implant System, OSSTEM IMPLANT CO.,LTD K100245 HS, HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K130662 ET Prosthetic System, OSSTEM IMPLANT CO.,LTD K062051 SS System, OSSTEM IMPLANT CO.,LTD K073247 US.SS.GS System, OSSTEM IMPLANT CO.,LTD K121843 NP Cast Abutment System, OSSTEM IMPLANT CO.,LTD K081575 HU.HS.HG Prosthetic System, OSSTEM IMPLANT CO.,LTD K 132067 Multi Angled Abutment with carrier, OSSTEM IMPLANT CO.,LTD
4
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
4. Description:
The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.
The ET US SS Prosthetic system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The ET US SS Prosthetic system is substantially equivalent in design, function and intended use to the Predicate Devices as above.
| Item | Content | |
|---|---|---|
| Quick Temporary | ||
| Abutment | Description | Used temporary until final prosthesis is made to maintain |
| esthetic appearance. | ||
| Quick Temporary Abutment Set is consisted of Quick | ||
| Temporary Abutment and Ti Screw. | ||
| Material | Titanium Alloy + Plastic (Polyetherethereketone) | |
| Diameter (mm) | 4, 4.5 | |
| Height (mm) | 13.9, 14.3, 14.5, 14.6, 17.4, 17.8, 18.0, 18.1 | |
| Multi Abutment | Description | Used for edentulous mandible or maxilla. |
| Usually use to make full denture. | ||
| Screw Retained Restoration. | ||
| Used in screw type prosthetics in multiple cases. | ||
| Multi Abutment Set is consisted of Multi Abutment and | ||
| Multi Abutment Carrier. | ||
| Material | Titanium Alloy (TiN Coating) | |
| Diameter (mm) | 4.8 | |
| Height (mm) | 8.3, 8.7, 9.3 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7 |
ET System
SS System
| Item | Content |
|---|---|
| Solid Abutment | Description |
| Used in producing ordinary cement-retained prosthetics. | |
| Solid Abutment Set is consisted of Solid Abutment and | |
| Solid Protect Cap. | |
| Material | |
| Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | |
| 3.5, 4.3 | |
| Height (mm) | |
| 9.5, 9.8, 11, 11.3, 12.5, 12.8 | |
| Solid Protect Cap | Description |
| Used to protect Solid abutments in the oral cavity. | |
| Material | |
| Polymer (Polycarbonate) | |
| Diameter (mm) | |
| 5.3, 6.02 | |
| Excellent Solid Abutment | Description |
| Used in producing cement-retained prosthetics. | |
| Excellent Solid Abutment Set is consisted of Excellent | |
| Solid Abutment and Solid Protect Cap. | |
| Material | |
| Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | |
| 4.3, 5.29 |
5
Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in a bold, sans-serif font in orange color. Below the word "OSSTEM", the word "IMPLANT" is written in a smaller, sans-serif font in gray color. The logo is simple and modern.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Height (mm) | 9.5, 9.7, 11, 11.2, 12.5, 12.7 | |
|---|---|---|
| Excellent Solid | ||
| Protect Cap | Description | Used to protect Excellent Solid Abutments in the oral cavity. |
| Material | Polymer (Polycarbonate) | |
| Diameter (mm) | 5.3, 6.6 | |
| ComOcta Abutment | Description | Used for making general cement-type prosthesis. |
| ComOcta Abutment is consisted of ComOcta Abutment and Ti Screw. | ||
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 4.3, 5.26 | |
| Height (mm) | 6.53, 6.55, 6.88, 6.90, 8.03, 8.05, 8.38, 8.40, 9.53, 9.55, | |
| 9.88, 9.90 | ||
| ComOcta Plus Abutment | Description | Used for making general cement-type prosthesis and used when there is deep gingiva or a fixture is to be deeply inserted.Gold coloring on gingiva region is for aesthetics. |
| ComOcta Plus Abutment Set is consisted of ComOcta Plus Abutment and Ti Screw. | ||
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 4.8, 6.0 | |
| Height (mm) | 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 | |
| ComOcta Angled | ||
| Abutment | Description | Used for prosthetic restoration and path adjustment of prosthesis in case of 15° and 20° axial angle. |
| ComOcta Angled Abutment Set is consisted of ComOcta Angled Abutment and Ti Screw. | ||
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 3.75, 4.3 | |
| Height (mm) | 5.5, 6.7 | |
| ComOcta Retraction Cap | Description | Used to protect ComOcta abutments in the oral cavity |
| Material | Polymer (PolyOxy Methylene) | |
| Diameter (mm) | 6.4, 7.7 |
US System
| Item | Content | |
|---|---|---|
| Cover Screw | Description | |
| Material | ||
| Diameter (mm) | ||
| Height (mm) | Used to protect other substances from ingressing into the fixture after the sugical operation. | |
| Titanium (ASTM F 67) | ||
| 3.7, 4.3, 5.2, 5.3 | ||
| 5.9 | ||
| Healing Abutment | Description | |
| Material | ||
| Diameter (mm) | ||
| Height (mm) | Used to form the appropriate gingival shape after the second surgery. | |
| Titanium (ASTM F 67) | ||
| 4, 5, 6, 7 | ||
| 7.9, 8.9, 9.9, 11.4, 12.9 | ||
| Cemented Abutment | Description | |
| Material | ||
| Diameter (mm) | Used for making general cement-type prosthesis. | |
| Titanium Alloy (ASTM F 136) | ||
| 4.0, 4.1, 5.0, 5.1, 6.0, 7.0 |
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Image /page/6/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and consists of the word "OSSTEM" in a bold, sans-serif font, with the word "IMPLANT" in a smaller, lighter font underneath. The logo is simple and modern, and the orange color is eye-catching.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Height (mm) | 5.0, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0, 11.0 | |
|---|---|---|
| Ti Screw | Description | Used to connect abutment with fixture. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 2.3, 2.9, 3.2 | |
| Height (mm) | 8.0, 8.2 | |
| US Multi Angled | ||
| Abutment | Description | If a few number of fixture were implanted in mandibular |
| bone for making full denture, some of fixture path should | ||
| be leaned. In that case, US Multi Angled Abutment is used | ||
| to adjust path of prosthesis in case of 17 and 30° axial | ||
| angle. | ||
| US Multi Angled Abutment Set is consisted of US Multi | ||
| Angled Abutment, Ti Screw, and Abutment Carrier. | ||
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 3.4, 4.0, 4.1 | |
| Height (mm) | 3.97, 3.98, 4.28, 4.77, 4.78, 5.28, 5.47, 6.28 | |
| Ti Screw | Description | Used to connect abutment with fixture. |
| Material | Titanium Alloy (ASTM F 136) | |
| Diameter (mm) | 2.2, 2.3 | |
| Height (mm) | 4.9, 5.55 | |
| Esthetic-low Abutment | Description | Used in producing screw-retained aesthetic prosthetics. |
| Structure producing prosthetics in cylinder after attaching | ||
| abutment in the oral cavity. | ||
| Esthetic-low Abutment Set is consisted of Esthetic-low | ||
| Abutment and Esthetic-low Abutment Screw. | ||
| Material | Titanium (ASTM F67) | |
| Diameter (mm) | 4.8, 5.5 | |
| Height (mm) | 2.1, 2.2, 3.0, 3.1, 4.0, 4.1, 5.0, 5.1 | |
| Esthetic-low Abutment | ||
| Screw | Description | Used to connect Esthetic-low abutment with fixture. |
| Material | Titanium (ASTM F67) | |
| Diameter (mm) | 3.1, 3.6 | |
| Height (mm) | 7.8, 7.9, 8.8, 8.9, 9.8, 9.9, 10.8, 10.9 | |
| Esthetic-low Temporary | ||
| Cylinder | Description | Used in producing temporary prosthetics. |
| Esthetic-low Temporary Cylinder is consisted of Esthetic- | ||
| low Temporary Cylinder and Ti Screw. | ||
| Material | Titanium (ASTM F 67) | |
| Diameter (mm) | 4.8, 5.5 | |
| Height (mm) | 12.0 | |
| O-ring Abutment | Description | Used in creating stud type overdenture prosthetics. |
| Material | Titanium Alloy | |
| Diameter (mm) | 5.0, 5.6 | |
| Height (mm) | 2.0, 3.0, 4.0, 5.0, 6.0 |
5. Indications for Use:
ET System
The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/ SS System
The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
7
Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray and is located below the word "OSSTEM".
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
6. Substantial Equivalence Matrix:
| Proposed Device | Primary Predicate Device | Reference Predicate | |
|---|---|---|---|
| 510K | - | K062030 | K130662 |
| Indications for | |||
| Use | ET System | ||
| The HIOSSEN | |||
| Prosthetic system is | |||
| intended for use with a | |||
| dental implant to | |||
| provide support for | |||
| prosthetic restorations | |||
| such as crowns, bridges, | |||
| or over-dentures. |
US/ SS System
The OSSTEM Prosthetic
system is intended for use
with a dental implant to
provide support for
prosthetic restorations
such as crowns, bridges,
or over-dentures. | Us system and ssii mini are
intended for use in partially
or fully edentulous mandibles
and maxillae, in support of
single or multiple-unit
restorations including:
cemented retained, screw
retained, or overdenture
restorations, and terminal or
intermediate abutment
support for fixed bridgework.
Us system is for two stage
surgical procedures. It is not
for one stage or immediate
load. Ssii mini is for one and
two stage surgical procedures.
It is not for immediate load. | ET Prosthetic
Systems is intended
for use with a dental
implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
overdentures. |
The Indications for Use of the submission device differs from the primary predicate as in that the submission Indications are specific to the sub-set of devices, that is abutments, which have been included in the current submission. The primary predicate contains devices for a complete implant system and the Indications reflects this. Since the current submission is a sub-set of devices included in the primary predicate, the modification of the Indications to a sub-set of the primary predicate Indications is also appropriate. The Indications for the submission device are also identical to a reference predicate which only contains a similar abutment sub-set of devices.
Subtantial Equivalence Matrixes for each specific device are provided as shown below.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K121843 |
| Material | Titanium Alloy | |
| PEEK | Titanium Alloy | |
| PEEK | ||
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make temporary | |
| prosthesis | Used to make temporary | |
| prosthesis | ||
| Principles of | ||
| Operation | Quick Temporary Abutment is | |
| used in producing temporary | Quick Temporary Abutment is | |
| used in producing temporary |
8
Image /page/8/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray font.
| | prosthetics for immediate loading
Upper part is made with plastic
(PEEK) for easy altering/removing
when make temporary prosthetics | prosthetics for immediate loading
Upper part is made with plastic
(PEEK) for easy altering/removing
when make temporary prosthetics |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension
(Diameter) | 4mm, 4.5mm | 4.5mm, 5.5mm |
| Connection | Internal Hex Connection | Internal Hex Connection |
| Characteristic | Cement retained restoration.
Capable of easily altering/removing
shape of plastic material.
Abutment + Screw | Cement retained restoration.
Capable of easily
altering/removing shape of plastic
material.
Abutment + Screw |
| Design | Image: Abutment with screw | Image: Abutment with screw |
| SE | Difference:
Shape of upper part (Plastic part) is different from predicate, Quick
Temporary Abutment
It is designed to be used when limitations in space (narrow space )
The Quick Temporary Abutment had been cleared with K121585 but it
is being sumitted to add revised shape therefore Quick Temporary
Abutmet and Predicate devices have same principles of operation,
function, material, Connection structure, charateristic and intended use | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062051 |
| Material | Titanium Alloy | Titanium Alloy |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make Cement-retained | |
| prosthesis | Used to make Cement-retained | |
| prosthesis | ||
| Principles of | ||
| operation | As general one body cement | |
| retained restoration, it is connected | ||
| with fixture and cemented crown | ||
| on the abutment | As general one body cement | |
| retained restoration, it is connected | ||
| with fixture and cemented crown | ||
| on the abutment | ||
| Dimension | ||
| (Height) | 9.5mm, 9.8mm, 11mm, 11.3mm, | |
| 12.5mm, 12.8mm | 9.5mm, 9.8mm, 11mm, 11.3mm, | |
| 12.5mm | ||
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restoration | |
| Abutment + Protect Cap | Cement retained restoration | |
| Abutment + Protect Cap |
9
Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, and the word "IMPLANT" is written in gray below it. The font is sans-serif and appears to be bolded.
| Design | Image: dental abutment | Image: dental abutment |
|---|---|---|
| Difference: | ||
| New dimension is added. | ||
| S E | The Solid Abutment had been cleared with K062051, but it is being | |
| sumitted to add a new dimension. Therefore, Solid Abutment and | ||
| Predicate devices have same principles of operation, function, material, | ||
| connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Solid Protect Cap | Solid Protect Cap | |
| 510K | K062051 | |
| Material | Polymer (Polycarbonate) | Polymer (Polycarbonate) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to protect Solid Abutment in | |
| the oral cavity | Used to protect Solid Abutment in | |
| the oral cavity | ||
| Principles of | ||
| operation | Solid Protect Cap is connected | |
| with Solid Abutment to protect in | ||
| the oral cavity and minimize | ||
| foreign body sensation by the | ||
| patient | Solid Protect Cap is connected | |
| with Solid Abutment to protect in | ||
| the oral cavity and minimize | ||
| foreign body sensation by the | ||
| patient | ||
| Dimension | ||
| (diameter) | 5.3mm, 6.02mm | 5.5mm, 6.7mm |
| Characteristic | Protect abutment in the oral cavity | Protect abutment in the oral cavity |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference: | |
| New dimension is added and shape is changed. | ||
| The Solid Protect Cap had been cleared with K062051, but it is being | ||
| sumitted to add a new dimension added and its shape changed. | ||
| Therefore, Solid Protect Cap and Predicate devices have same principles | ||
| of operation, function, material, charateristic and intended use. |
10
Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below it, the word "IMPLANT" is in smaller, gray letters. The logo is simple and modern.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062051 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make Cement-retained | |
| prosthesis | Used to make Cement-retained | |
| prosthesis | ||
| Principles of | ||
| operation | As general one body cement | |
| retained restoration, it is connected | ||
| with fixture and cemented crown | ||
| on the abutment | As general one body cement | |
| retained restoration, it is connected | ||
| with fixture and cemented crown | ||
| on the abutment | ||
| Dimension | ||
| (Height) | 9.5mm, 9.7mm, 11mm, 11.2mm, | |
| 12.5mm, 12.7mm | 9.5mm, 9.7mm, 11mm, 11.2mm, | |
| 12.5mm | ||
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restoration | |
| Abutment + Protect Cap | Cement retained restoration | |
| Abutment + Protect Cap | ||
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference: | |
| New dimension is added. | ||
| The Excellent Solid Abutment had been cleared with K062051, but it is | ||
| being sumitted to add a new dimension. Therefore, Solid Abutment and | ||
| Predicate devices have same principles of operation, function, material, | ||
| connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Excellent Solid Protect Cap | Excellent Solid Protect Cap | |
| 510K | - | K062051 |
| Material | Polymer (Polycarbonate) | Polymer (Polycarbonate) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to protect Excellent Solid | |
| Abutment in the oral cavity | Used to protect Excellent Solid | |
| Abutment in the oral cavity | ||
| Principles of | ||
| operation | Excellent Solid Protect Cap is | |
| connected with Solid Abutment to | ||
| protect in the oral cavity and | ||
| minimize foreign body sensation | ||
| by the patient | Excellent Solid Protect Cap is | |
| connected with Solid Abutment to | ||
| protect in the oral cavity and | ||
| minimize foreign body sensation | ||
| by the patient | ||
| Dimension | ||
| (Height) | 6.35mm, 7.85mm, 9.35mm, | |
| 9.65mm | 6.35mm, 7.85mm, 9.35mm |
11
I M P L A N 1
| Characteristic | Protect abutment in the oral cavity | Protect abutment in the oral cavity |
|---|---|---|
| Design | Image: Protect abutment in the oral cavity | Image: Protect abutment in the oral cavity |
| S E | Difference: | |
| New dimension is added. | ||
| The Excellent Solid Protect Cap had been cleared with K062051, but it | ||
| is being sumitted to add a new dimension. Therefore, Solid Protect Cap | ||
| and Predicate devices have same principles of operation, function, | ||
| material, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | ComOcta Abutment | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make Cement-retained | |
| prosthesis | Used to make Cement-retained | |
| prosthesis | ||
| Principles of | ||
| operation | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | ||
| Dimension | ||
| (Height) | 6.53mm, 6.55mm, 6.88mm, | |
| 6.90mm, 8.03mm, 8.05mm, | ||
| 8.38mm, 8.40mm, 9.53mm, | ||
| 9.55mm, 9.88mm, 9.90mm | 6.53mm, 6.55mm, 6.88mm, | |
| 6.90mm, 8.03mm, 8.05mm, | ||
| 8.38mm, 8.40mm, 9.53mm, | ||
| 9.55mm | ||
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restoration | |
| Abutment + Screw | Cement retained restoration | |
| Abutment + Screw | ||
| Design | Image: ComOcta Abutment design | Image: ComOcta Abutment design |
| SE | Difference: | |
| New dimensions are added. | ||
| The ComOcta Abutment had been cleared with K062051, but it is being | ||
| sumitted to add new dimension. Therefore, ComOcta Abutment and |
12
Image /page/12/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Predicate devices have same principles of operation, function, material, connection structure, charateristic and intended use.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| ComOcta Plus Abutment | ComOcta Plus Abutment | |
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make Cement-retained | |
| prosthesis | ||
| Used when there is deep gingiva or | ||
| a fixture is to be deeply inserted | Used to make Cement-retained | |
| prosthesis | ||
| Used when there is deep gingiva or | ||
| a fixture is to be deeply inserted | ||
| Principles of | ||
| operation | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | ||
| Dimension | ||
| (Height) | 6.5mm, 7mm, 7.5mm, 8mm, | |
| 8.5mm, 9mm, 9.5mm, 10mm | 7.5mm, 8mm, 9.5mm, 10mm | |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restoration | |
| Abutment + Screw | ||
| Gold coloring on gingiva region | ||
| for asthetics | Cement retained restoration | |
| Abutment + Screw | ||
| Gold coloring on gingiva region | ||
| for asthetics | ||
| Design | Image: abutment | Image: abutment |
| SE | Difference: | |
| New dimensions and Non-Octa type abutments are added. | ||
| The ComOcta Plus Abutment had been cleared with K073247, but it is | ||
| being sumitted to add new dimensions and Non-Octa type abutments. | ||
| Therefore, ComOcta Plus Abutment and Predicate devices have same | ||
| principles of operation, function, material, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| ComOcta Angled Abutment | ComOcta Angled Abutment | |
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | Used for prosthetic restoration | Used for prosthetic restoration |
13
MPLAN7
| (Intended for use) | Used for the path adjustment of
prosthesis in case of 15° and 20°
axial angle | Used for the path adjustment of
prosthesis in case of 15° and 20°
axial angle |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principles of
operation | As general cement retained
restoration, it is connected with
fixture and cemented crown on the
abutment
ComOcta Angled Abutment has
15° and 20° axial angle for path
adjustment of prosthesis | As general type cement retained
restoration, it is connected with
fixture and cemented crown on the
abutment
ComOcta Angled Abutment has
15° and 20° axial angle for path
adjustment of prosthesis |
| Dimension
(diameter) | 3.75mm, 4.3mm | 3.75mm, 4.3mm |
| Connection | Internal Octa Connection | Internal Octa Connection |
| Characteristic | Cement retained restoration
Abutment + Screw | Cement retained restoration
Abutment + Screw |
| Design | Image: Design 1 | Image: Design 2 |
| SE | Difference:
Non-Octa type abutments are added.
The ComOcta Angled Abutment had been cleared with K073247, but it
is being sumitted to add Non-Octa type. Therefore, ComOcta Angled
Abutment and Predicate devices have same principles of operation,
function, material, charateristic and intended use. | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062030 |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to protect other substances | |
| from ingressing into the fixture | ||
| after the surgical operation | Used to protect other substances | |
| from ingressing into the fixture | ||
| after the surgical operation | ||
| Principles of | ||
| operation | Cover Screw is connected with | |
| implanted fixture to protect other | ||
| substances from ingressing into the | ||
| fixture after the surgical operation | Cover Screw is connected with | |
| implanted fixture to protect other | ||
| substances from ingressing into the | ||
| fixture after the surgical operation | ||
| Dimension | ||
| (diameter) | 3.7mm, 4.3mm, 5.2mm, 5.3mm | 3.7mm, 4.3mm, 5.3mm |
| Characteristic | Used to protect other substances | |
| from ingressing into the fixture | Used to protect other substances | |
| from ingressing into the fixture |
14
OSSTEM
IMPLANT
| Design | Image: screw | Image: screw |
|---|---|---|
| S E | Difference: | |
| New dimension is added. |
The Cover Screw had been cleared with K062030, but it is being
sumitted to add a new dimensio. Therefore, Cover Screw and Predicate
devices have same principles of operation, function, material,
charateristic and intended use. | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Healing Abutment | Healing Abutment | |
| 510K | K062030 | |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to form the appropriate | |
| gingival shape after the seconds | ||
| surgery | Used to form the appropriate | |
| gingival shape after the seconds | ||
| surgery | ||
| Principles of | ||
| operation | Healing Abutment is connected | |
| with implanted fixture to form the | ||
| appropriate gingival shape after | ||
| the seconds surgery | Healing Abutment is connected | |
| with implanted fixture to form the | ||
| appropriate gingival shape after the | ||
| seconds surgery | ||
| Dimension | ||
| (diameter) | 4mm, 4.13mm, 5mm, 5.1mm, | |
| 5.13mm, 6mm, 7mm | 4mm, 5mm, 6mm, 7mm | |
| Characteristic | Used to protect other substances | |
| from ingressing into the fixture | Used to protect other substances | |
| from ingressing into the fixture | ||
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference: | |
| New dimensions and shape are added. | ||
| The Healing Abutment had been cleared with K062030, but it is being | ||
| sumitted to add new dimensions and shape. Therefore, Healing | ||
| Abutment and Predicate devices have same principles of operation, | ||
| function, material, charateristic and intended use. |
15
Image /page/15/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in large, bold, orange letters. Below it, the word "IMPLANT" is in smaller, gray letters. The logo is simple and modern.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K073247 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to make Cement-retained | |
| prosthesis | Used to make Cement-retained | |
| prosthesis | ||
| Principles of | ||
| operation | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | As general cement retained | |
| restoration, it is connected with | ||
| fixture and cemented crown on the | ||
| abutment | ||
| Dimension | ||
| (diameter) | 4.0mm, 4.1mm, 5.0mm, 5.1mm, | |
| 6.0mm, 7.0mm | 4.0mm, 5.0mm, 6.0mm, 7.0mm | |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Cement retained restoration | |
| Abutment + Screw | Cement retained restoration | |
| Abutment + Screw | ||
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| SE | Difference: | |
| New dimension are added. | ||
| The Cemented Abutment had been cleared with K073247, but it is being | ||
| sumitted to add a new dimension. Therefore, Cemented Abutment and | ||
| Predicate devices have same principles of operation, function, material, | ||
| connection structure, charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Ti Screw | Ti Screw | |
| 510K | - | K062030 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description (Intended for use) | Used to connect abutment with fixture | Used to connect abutment with fixture |
| Principles of operation | Connect an abutment with fixture using by screw | Connect an abutment with fixture using by screw |
| Dimension (diameter) | 2.3mm, 2.9mm, 3.2mm | 2.5mm, 2.6mm, 2.9mm, 3.2mm |
| Characteristic | Connect an abutment with fixture | Connect an abutment with fixture |
16
0
| Design | Image: Screw | Image: Screw |
|---|---|---|
| Difference: | ||
| New dimension is added. | ||
| S E | The Ti Screw had been cleared with K062030, but it is being sumitted to | |
| add new code for new dimension added. Therefore, Ti Screw and | ||
| Predicate devices have same principles of operation, function, material, | ||
| charateristic and intended use. |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Esthetic-low Abutment | Esthetic-low Abutment | |
| 510K | - | K062030 |
| Material | Titanium (ASTM F67) | Titanium (ASTM F67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used in producing screw-retained | |
| aesthetic prosthetics | ||
| Structure producing prosthetics in | ||
| cylinder after attaching abutment | ||
| in the oral cavity | Used in producing screw-retained | |
| aesthetic prosthetics | ||
| Structure producing prosthetics in | ||
| cylinder after attaching abutment | ||
| in the oral cavity | ||
| principles of | ||
| operation | Esthetic-low abutment is | |
| connected to implanted fixture and | ||
| upper part is connected to cylinder | ||
| Esthetic-low abutment uses | ||
| cylinder screw to fasten screw- | ||
| retained type prosthesis | Esthetic-low abutment is | |
| connected to implanted fixture and | ||
| upper part is connected to cylinder | ||
| Esthetic-low abutment uses | ||
| cylinder screw to fasten screw- | ||
| retained type prosthesis | ||
| Dimension | ||
| (Diameter of | ||
| Connection) | 2.41mm, 2.71mm, 3.41mm | 2.71mm, 3.41mm |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Screw retained prosthesis | Screw retained prosthesis |
| Design | Image: Design of Esthetic-low Abutment | Image: Design of Esthetic-low Abutment |
| SE | Difference: | |
| New dimensions are added. | ||
| The Esthetic-low Abutment had been cleared with K062030, but it is | ||
| being sumitted to add new dimensions. Therefore, Esthetic-low | ||
| Abutment and Predicate devices have same principles of operation |
17
Image /page/17/Picture/1 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray and is located below the word "OSSTEM".
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
function, material, connection structure, charateristic and intended use.
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| O-ring Abutment | O-ring Abutment | O-ring Abutment |
| 510K | - | K062030 |
| Material | Titanium Alloy | Titanium Alloy |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used in creating stud type | |
| overdenture prosthetics | Used in creating stud type | |
| overdenture prosthetics | ||
| principles of | ||
| operation | O-ring abutment is generally | |
| applied to prosthetic procedure | ||
| for overdentures. | ||
| Its O-ring attachment retained | ||
| abutment, connected to fixture, | ||
| and then acts as the male | ||
| counterpart | O-ring abutment is generally applied | |
| to prosthetic procedure for | ||
| overdentures. | ||
| Its O-ring attachment retained | ||
| abutment, connected to fixture, and | ||
| then acts as the male counterpart | ||
| Dimension | ||
| (diameter) | 5.0mm, 5.6mm | 5.0mm |
| Connection | External Hex Connection | External Hex Connection |
| Characteristic | Stud type overdenture prosthesis | Stud type overdenture prosthesis |
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
| S E | Difference: | |
| New dimensions are added. | ||
| The O-ring Abutment had been cleared with K062030, but it is being | ||
| submitted to add new dimensions added. Therefore, O-ring Abutment | ||
| and Predicate devices have same principles of operation, function, | ||
| material, connection structure, characteristic and intended use. |
| Proposed Device | Predicate Device | |
|---|---|---|
| Part Name | ComOcta Retraction Cap | Excellent Solid Retraction cap |
| 510K | - | K100245 |
| Material | Polymer (POM) | Polymer (POM) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
18
Image /page/18/Picture/0 description: The image shows the text "Section 003" in a clear, sans-serif font. The text is presented in a warm, orange color, which makes it stand out against the white background. The words are arranged on a single line, with "Section" appearing first, followed by a space, and then the number "003".
Image /page/18/Picture/1 description: The image shows the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small circle above the "M" in "OSSTEM".
| Description
(Intended for use) | Used to protect ComOcta
abutments in the oral cavity and
minimize foreign body
sensation by the patient
Accurate margin impression
function when taking
impression directly from a
ComOcta abutment | Used for the protection of the
Excellent solid abutment on thepatient's discomfort. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimension
(Diameter) | 6.4, 7.7mm | 6.4, 7.7mm |
| Design | Image: ComOcta Retraction Cap | Image: Excellent Solid Retraction Cap |
| Principles of
operation | ComOcta Retraction Cap is
temporary connected with
ComOcta abutment for
minimize foreign body
sensation by the patient and
accurate margin impression
function when taking
impression directly from a
ComOcta abutment | Excellent Solid Retraction Cap
is temporary connected with
Excellent Solid abutment for
minimize foreign body
sensation by the patient and
accurate margin impression
function when taking
impression directly from a
Excellent solid abutment |
| SE | Different
Only connection shape is different because of difference of
compatible abutment post shape | |
| | ComOcta Retraction Cap is elementally the same to Excellent
Solid Retraction cap (K100245) Such as principles of operation.
function, material, charateristic and intended use but connection
shape is different depend on abutment shape | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K132067 |
| Material | titanium alloy (ASTM F 136) | titanium alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | If a few number of fixture were | |
| implanted in mandibular bone | ||
| for making full denture, some | ||
| of fixture path should be leaned. | ||
| In that case, US Multi Angled | If a few number of fixture were | |
| implanted in mandibular bone | ||
| for making full denture, some | ||
| of fixture path should be leaned. | ||
| In that case, Multi Angled |
19
Image /page/19/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. The logo is simple and modern, and it is likely used to promote the company's dental implant products.
Section 003
| | Abutment is used to adjust path
of prosthesis. | Abutment is used to adjust path
of prosthesis. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Dimension
(Diameter) | 3.4, 4.0, 4.1mm | 2.84, 2.88, 3.39, 4.9mm |
| Connection | external Hex Connection | Internal Hex Connection |
| Characteristic | Screw retained restoration.
Connected with Cylinder
Abutment + Screw | Screw retained restoration.
Connected with Cylinder
Abutment + Screw |
| Design | Image: Angled abutment | Image: Angled abutment with cylindrical base |
| Principles of
operation | US Multi Angled Abutment is
connected implanted fixture and
upper part is connected cylinder | Multi Angled Abutment is
connected implanted fixture and
upper part is connected cylinder |
| SE | Difference:
US Multi Angled Abutment has different connection structure
connected implanted fixture from Predicate device, Multi Angled
Abutment (K132067) because US Multi Angled Abutment is
connected with external Hex Connection fixture and Multi Angled
Abutment is connected with Internal Hex Connection fixture
But elementally US Multi Angled Abutment and Predicate devices
have same principles of operation, function, material, Connection
structure connected with cylinder, charateristic and intended use | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| Ti Screw | Ti Screw | |
| 510K | - | K062030 |
| Material | Titanium Alloy (ASTM F 136) | Titanium Alloy (ASTM F 136) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Used to connect abutment with | |
| fixture | Used to connect abutment with | |
| fixture | ||
| Principles of | ||
| Operation | Connect an abutment with | |
| fixture using by screw | Connect an abutment with fixture | |
| using by screw | ||
| Dimension | ||
| (Diameter) | 2.2mm, 2.3mm | 2.5mm, 2.6mm, 2.9mm, 3.2mm |
| Characteristic | Connect an abutment with | |
| fixture using by screw | Connect an abutment with fixture |
20
Section 003
Image /page/20/Picture/1 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. The logo is simple and modern.
OSSTEM Implant Co., Ltd.
| Design | Image: screw design 1 | Image: screw design 2 |
|---|---|---|
| SE | Difference: | |
| Dimensions are different between proposed device and predicate device. |
But elementally Ti screw and Predicate devices have same
principles of operation, function, material, characteristic and
intended use. | |
| Part Name | Proposed Device | Predicate Device |
|---|---|---|
| 510K | - | K062030 |
| Material | Titanium (ASTM F 67) | Titanium (ASTM F 67) |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Description | ||
| (Intended for use) | Esthetic-low Temporary | |
| Cylinder is used for prosthetic | ||
| restoration. This is used to | ||
| make temporary prosthesis and | ||
| designed to minimized | ||
| indication constraints | Esthetic-low Temporary | |
| Cylinder is used for prosthetic | ||
| restoration. This is used to | ||
| make temporary prosthesis and | ||
| designed to minimized | ||
| indication constraints | ||
| Dimension | ||
| (Diameter) | 4.8, 5.5mm | 4.8, 5.5mm |
| Connection | external Hex Connection | external Hex Connection |
| Characteristic | Cement retained restoration. | |
| Abutment + Screw | Cement retained restoration. | |
| Abutment + Screw | ||
| Principles of | ||
| operation | Esthetic-low Temporary | |
| Cylinder is used in producing | ||
| temporary prosthetics that is | ||
| connected with Esthetic-low | ||
| Abutment for immediate | ||
| loading | Esthetic-low Temporary | |
| Cylinder is used in producing | ||
| temporary prosthetics that is | ||
| connected with Esthetic-low | ||
| Abutment for immediate | ||
| loading | ||
| Design | Image: Proposed Device Design | Image: Predicate Device Design |
21
Section 003
Image /page/21/Picture/1 description: The image contains the logo for OSSTEM IMPLANT. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, sans-serif font. The logo is simple and modern.
)SSTEM Implant Co., Ltd.
6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| | Difference:
Post shape of subject device is different with predicate
Addition of new post shape |
|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SE | Esthetic-low Temporary Cylinder is exactly same with predicated
device, Esthetic-low Temporary Cylinder in principles of
operation, function, material, Connection structure, charateristic
and intended use |
7. Summary of nonclinical testing:
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
Biocompatibility
Material in use, manufacturing process, surface treatment, and sterilization method is same as the predicates, US System, OSSTEM IMPLANT CO., LTD., K062030; TS Implant System, OSSTEM IMPLANT CO., LTD., K121585; HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K100245; ET Prosthetic System, OSSTEM IMPLANT CO., LTD., K130662; SS System, OSSTEM IMPLANT CO., LTD., K062051; US, SS, GS System, OSSTEM IMPLANT CO., LTD., K073247; NP Cast Abutment System, OSSTEM IMPLANT CO., LTD., K121843; HU, HS, HG Prosthetic System, OSSTEM IMPLANT CO., LTD., K081575; and Multi Angled Abutment with carrier, OSSTEM IMPLANT CO., LTD., K132067. Therefore, no additional testing is required to support the biological safety of the subject devices.
Sterilization Validation
For Cover Screw and Healing Abutment, the test result is considered to be substantial equivalent to that of the predicate, GSII RBM Fixture of GS Fixture System, OSSTEM IMPLANT CO., LTD., K072896; therefore, no additional testing is required. Except for them, the rest are non-sterile devices and are conducted of steam sterilization validation according to ISO 17665-1:2006.
Fatigue Test
Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario.
-
- Summary of clinical testing:
No clinical studies are submitted.
- Summary of clinical testing:
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based
- Conclusions:
22
Image /page/22/Picture/1 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray underneath. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells dental implants.
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
on the information provided in this premarket notification OSSTEM CO., LTD. concludes that ET US SS Prosthetic system is substantially equivalent to the predicate devices as described herein.