Who is the manufacturer of ET US SS Prosthetic system?

Osstem Implant Co., Ltd. filed the 510(k) submission for ET US SS Prosthetic system (K160670).

What is the FDA product code for ET US SS Prosthetic system?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ET US SS Prosthetic system?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ET US SS Prosthetic system?

US System (K062030); TS Implant System (K121585); HS, HG Prosthetic System (K100245); ET Prosthetic System (K130662); SS System (K062051); US.SS.GS System (K073247); NP Cast Abutment System (K121843); HU.HS.HG Prosthetic System (K081575); Multi Angled Abutment with carrier (K132067).

Who can help prepare an FDA 510(k) submission like ET US SS Prosthetic system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ET US SS Prosthetic system

K160670 · Osstem Implant Co., Ltd. · NHA · Apr 25, 2017 · Dental

Device Facts

Record ID	K160670
Device Name	ET US SS Prosthetic system
Applicant	Osstem Implant Co., Ltd.
Product Code	NHA · Dental
Decision Date	Apr 25, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

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. 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.

Device Story

The ET US SS Prosthetic system consists of various dental abutments, components, and abutment screws used to support prosthetic restorations (crowns, bridges, over-dentures) on dental implants. The system includes temporary abutments, multi-abutments, solid abutments, ComOcta abutments, cover screws, healing abutments, and retraction caps. These components are connected to dental fixtures (implants) via internal or external hex/octa connections. The device is used by dental professionals in a clinical setting to facilitate the restoration of edentulous or partially edentulous patients. The components are made of titanium alloy, titanium, or polymers (PEEK, polycarbonate, POM). The system provides the mechanical interface between the implant fixture and the final or temporary prosthesis, enabling functional and aesthetic restoration. Some components allow for path adjustment (angled abutments) or gingival shaping (healing abutments).

Clinical Evidence

No clinical studies were submitted. Substantial equivalence is supported by non-clinical testing, including biocompatibility assessments, sterilization validation (ISO 17665-1:2006), and fatigue testing conducted according to FDA guidance for root-form endosseous dental implants and abutments.

Technological Characteristics

Materials: Titanium Alloy (ASTM F136), Titanium (ASTM F67), PEEK, Polycarbonate, PolyOxy Methylene (POM). Connection types: Internal Hex, Internal Octa, External Hex. Components: Abutments, screws, caps. Sterilization: Steam sterilization (ISO 17665-1:2006) for non-sterile components. Design: Mechanical dental abutment system.

Indications for Use

Indicated for use with dental implants to support prosthetic restorations including crowns, bridges, or over-dentures in patients requiring dental implant-supported prosthetics.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

US System (K062030)
TS Implant System (K121585)
HS, HG Prosthetic System (K100245)
ET Prosthetic System (K130662)
SS System (K062051)
US.SS.GS System (K073247)
NP Cast Abutment System (K121843)
HU.HS.HG Prosthetic System (K081575)
Multi Angled Abutment with carrier (K132067)

Reference Devices

GSII RBM Fixture of GS Fixture System (K072896)

Related Devices

K130662 — ET PROSTHETIC SYSTEM · Osstem Implant Co., Ltd. · Jan 10, 2014
K161689 — OSSTEM Implant System - Abutment · Osstem Implant Co., Ltd. · May 22, 2017
K221684 — Osstem Abutment System · Osstem Implant Co., Ltd. · Sep 8, 2022
K081101 — SPECTRA-SYSTEM ABUTMENTS 2008 · Implant Direct, LLC · Jan 14, 2009
K222636 — ET Abutment System · Hiossen, Inc. · Apr 28, 2023

Submission Summary (Full Text)

{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 1. 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 | - 2. 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 | - 3. Predicate Device: Primary Predicate K062030 US System, OSSTEM IMPLANT CO.,LTD 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 | {6}------------------------------------------------ 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…