Osstem Abutment System

K182091 · Osstem Implant Co., Ltd. · NHA · Jul 12, 2019 · Dental

Device Facts

Record IDK182091
Device NameOsstem Abutment System
ApplicantOsstem Implant Co., Ltd.
Product CodeNHA · Dental
Decision DateJul 12, 2019
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. · Link Abutment for CEREC The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Device Story

System comprises various titanium alloy and Co-Cr-Mo dental abutments and components; used to connect dental implants to prosthetic restorations (crowns, bridges, overdentures). Components include transfer, angled, temporary, stud, and port abutments, plus cylinders and screws. Link Abutment for CEREC integrates with Sirona CAD/CAM systems for customized restorations. Used in dental clinics by clinicians; CAD/CAM manufacturing occurs in dental laboratories. Provides structural support for prosthetics; enables path adjustment for implants; maintains esthetics during temporary phases. Benefits patients by restoring chewing function and dental esthetics.

Clinical Evidence

No clinical studies submitted. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), steam sterilization validation (ISO 17665-1), mechanical fatigue testing (ISO 14801), and retention testing for dental attachments.

Technological Characteristics

Materials: Titanium Alloy (ASTM F136), Titanium Gr. 3 (ASTM F67), Co-Cr-Mo Alloy, POM, Nylon, PC. Components include various abutments, cylinders, and screws. Connectivity: Compatible with Sirona CEREC CAD/CAM systems. Sterilization: Provided non-sterile; validated for steam sterilization (ISO 17665-1).

Indications for Use

Indicated for use with dental implants to support prosthetic restorations (crowns, bridges, overdentures). Link Abutment for CEREC indicated for screw-retained or cement-retained single tooth and bridge restorations.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". July 12, 2019 Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K182091 Trade/Device Name: Osstem Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 12, 2019 Received: June 13, 2019 Dear Peter Lee: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality 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" also appearing in orange next to the company name. The contact information includes the company's address, telephone number (+82 51 850 2500), fax number (+82 51 861 4693), and website (www.osstem.com). 510(k) Number: K182091 Device Name: Osstem Abutment System ### Indication for Use: Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. ### · Link Abutment for CEREC The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC. X Prescription Use (21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com # 510(k) Summary # K182091 Date: July 12, 2019 ### 1. Administrative Information | Submitter | OSSTEM IMPLANT Co., Ltd. | |---------------|-------------------------------------------------------------------| | - Address | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 612-070, Korea | | - Contact | Ms. Jungmin Yoo | | - Phone | +82-51-850-2575 | | Correspondent | HIOSSEN Inc. | | - Address | 85 Ben Fairless Dr. Fairless Hills, PA 19030 | | - Contact | Mr. Peter Lee | | - Phone | 267-759-7031 | # 2. Device Name and Classification | Trade or (Propreitary) Name | Osstem Abutment System | |-----------------------------|------------------------------------| | Common or Usual Name | Dental Abutment | | Classification Name | Endosseous dental implant abutment | | Regulation Number | 21 CFR 872.3630 | | Device Classification | Class II | | Product Code | NHA | # 3. Predicate Device | Primary Predicate | | |----------------------|------------------------------------------------------------| | K161689 | OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd. | | Reference Predicates | | | K160670 | ET US SS Prosthetic System | | K160519 | Link Abutment for CEREC, Osstem Implant Co., Ltd. | | K150295 | LOCATOR RTx, Zest Anchors, Inc. | | K140507 | Hiossen Prosthetic System, Osstem Implant Co., Ltd. | | K132067 | Multi Angled Abutment System, Osstem Implant Co., Ltd. | | K120847 | ET/SS Implant System, Osstem Implant Co., Ltd. | | K080594 | MS System (Narrow Ridge), Osstem Implant Co., Ltd. | | K063861 | GS System, Osstem Implant Co., Ltd. | | K062030 | US System, Osstem Implant Co., Ltd. | {4}------------------------------------------------ ### 4. Indication for Use Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. ### · Link Abutment for CEREC The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC. ### 5. Device Description | Manufacturer | Model Name | Connection | Diameter (mm) | |--------------------------|---------------|---------------|----------------------------------------------------------------------------------------------------------------------------| | Osstem Implant Co., Ltd. | TS SA Fixture | Internal Hex | 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63,<br>4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95,<br>6, 6.2, 6.8, 7.1 | | | SS SA Fixture | Internal Octa | 3.75, 4.1, 4.25, 4.45, 4.6, 4.9, 5, 5.05, 5.92,<br>5.95, 5.96, 6, 6.8, 6.93 | | | US SA Fixture | External Hex | 3.6, 4.2, 5.1, 5.2 | | | MS SA Implant | Narrow Ridge | 2.5, 2.9 | Osstem Abutment System is compatible with the following implant systems. Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics. Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above. | Device | Content | | |---------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Transfer Abutment | Description Transfer Abutment is used for prosthetic restoration. It | | | | | is used for making general cement-type prosthesis. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.0, 4.6, 5.0, 6.0, 7.0 | | | Post Height (mm) | 4.0, 5.5, 7.0 | | | Description | Angled Abutment is used for prosthetic restoration. It is used for making general cement-type prosthesis. It is used when a prosthetic's path adjustment is necessary | | Angled Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.0, 4.5, 5.0, 6.0 | | | Post Height (mm) | 8 | | | Angulation | 17° | | Link Abutment for Cerec | Description | Link Abutment for Cerec is used for customized prosthetic restoration. It is indicated for screw-retained single tooth or cement-retained single tooth and bridges restorations. It is compatible with the Sirona CEREC MC X and MC XL prosthetic milling system. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.5 | | | Post Height (mm) | 4.7 | | Temporary Abutment | Description | Temporary Abutment is used for prosthetic restoration. It is used temporarily to maintain esthetic appearance until final prosthesis is made. | | | Material | Titanium Gr.3 (ASTM F67) | | | Diameter (mm) | 4.0, 4.5 | | | G/H (mm) | 1.0, 3.0 | | Multi Angled Abutment | Description | If a few numbers of fixtures were implanted in mandibular bone for making full denture, some of fixture path should be leaned. Multi Angled Abutment is used to adjust path of prosthesis. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.9 | | | Height (mm) | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 | | | Angulation | 17°, 30° | | Multi NP-Cast Cylinder | Description | Multi NP-Cast Cylinder is used for prosthetic restoration. It is used for making screw-retained type prosthesis by casting with non-precious metal alloy; and used with Multi Abutment together. It creates framework of the final prosthesis to be fixed on top of the abutment. | | | Material | Co-Cr-Mo Alloy (Cylinder Body) + POM (Cylinder Sleeve) | | | Diameter (mm) | 5.0 | | | Length (mm) | 7.3 | | Multi Combination Cylinder | Description | Multi Combination Cylinder is used for prosthetic restoration. It is used for making combination-retained type prosthesis with using Multi Abutment together. It | | | | tope of the abutment. | | | Material | Titanium Gr. 3 (ASTM F67) | | | Diameter (mm) | 5.0 | | | Length (mm) | 7.3 | | Convertible Angled Cylinder | Description | Convertible Angled Cylinder is used for prosthetic<br>restoration. It is used for making combination-retaiend<br>type prosthesis by using with Convertible Abutment<br>together. It is used when path adjustment is necessary<br>at 17° axial angle. | | | Material | Titanium Gr. 3 (ASTM F67) | | | Diameter (mm) | 4.2, 5.0, 6.3 | | | Length (mm) | 7.8 | | | Angulation | 17° | | | Description | Stud Abutment is used for prosthetic restoration. It is<br>used for making stud type overdenture prosthetics. | | Stud Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 3.5 | | | Head length (mm) | 2.5 | | O-ring | Description | O-ring is inserted into retainer or retainer cap and<br>serves as a buffer for abutments/implants and denture<br>fixation. | | | Material | NBR (Acrylonitrile & Butadiene Polymer) | | | Diameter (mm) | 3.5 | | | Description | O-ring Retainer Cap is used for making stud-type<br>overdenture. It is inserted and fixed into denture; and is<br>connected with abutment/implants. | | O-ring Retainer Cap | Material | Titanium Gr. 3 (ASTM F67) | | | Diameter (mm) | 3.95 | | | Height (mm) | 2.9 | | | Description | Port Abutment is used for prosthetic restoration. It is<br>for implant retained overdenture at maxilla/mandible in<br>case of the patient has no teeth. | | Port Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 3.5, 3.7, 4.1, 4.8, 5.1 | | | G/H (mm) | 1, 2, 3, 4, 5, 6, 7 | | | Description | Port Angled Abutment is used for prosthetic<br>restoration. It is for implant retained overdenture<br>needed of path compensation at maxilla/mandible in<br>case of the patient has no teeth. | | Port Angled Abutment | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.63, 4.66, 4.68, 4.72, 4.73, 4.74, 4.77, 4.82 | | | Height (mm) | 6.5, 6.8, 7.5, 7.6 | | | Angulation | 10°, 17°, 30° | | Port Angled Abutment Head | Description | Port Angled Abutment Head is used for prosthetic<br>restoration. It is a part that is used to connect with Port<br>Angled Abutment. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 4.6 | | | Height (mm) | 3.7 | | Port Male, Port Extended Male | Description | Port Male and Port Extended Male is used for<br>prosthetic restoration. It is used to be inserted between<br>Port Abutment/Port Angled Abutment and Port Male<br>Cap and takes a role to maintain retention of<br>overdenture. | | | Material | Nylon | | | Diameter (mm) | 4.75 | | | Height (mm) | 1.8 | | Port Male Cap | Description | Port Male Cap is used for prosthetic restoration. It is<br>used to fix Port Male or Port Extended Male by<br>inserted into the denture. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 5.5 | | | Height (mm) | 2.25 | | Port Male Kit | Description | Port Male Kit is used for prosthetic restoration by<br>providing accessories that are used with Port Abutment<br>or Port Angled Abutment, and it is included of Port<br>Male Cap, Port Provisional Male, Port Spacer, and 3<br>different types of Port Male as a set. | | | Set Configuration | Port Male Cap + Port Provisional Male + Port Spacer +<br>Port Male (3ea) | | Abutment Screw | Description | Abutment Screw is used to connect an abutment to the<br>fixture. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 2, 2.05 | | | Length (mm) | 7.5, 9.6 | | Cylinder Screw | Description | Cylinder Screw is used to connect a cylinder to the<br>abutment. | | | Material | Titanium Alloy (Ti-6Al-4V, ASTM F136) | | | Diameter (mm) | 2.2, 2.5 | | | Length (mm) | 4.35, 4.9 | | Esthetic-low Temporary Cylinder | Description | Esthetic-low Temporary Cylinder is used for prosthetic<br>restoration. It is used for making temporary prosthesis<br>before loading final prosthesis. It is used by connected<br>with Multi Abutment, US Multi Angled Abutment or<br>Esthetic-low Abutment to make overdenture and bridge<br>as multiple cases. | | | Material | Titanium Gr. 3 (ASTM F67) | | | Diameter (mm) | 4.8, 5.5 | | | Length (mm) | 12 | | Temporary Cap (Narrow Ridge) | Description | Temporary Cap is used for prosthetic restoration<br>temporarily. It is a component used to protect upper<br>structure while final prosthesis is made. | | | Material | PC (Poly Carbonate) | | Diameter (mm) | 4 | | | Length (mm) | 9.6 | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript "6" next to it. Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript symbol for a registered trademark next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to it. Below the word "OSSTEM", the word "IMPLANT" is written in gray. 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 51 861 4693 www.osstem.com #### 6. Substantial Equivalence Discussion These subject devices are cleared in past 510(k) submissions but submitted to change their identifiers without modifications of dimensions or shape. Link Abutment for Cerec, K160519 Multi Angled Abutment, K132067 Abutment Screw, K132067 The Indications for Use Statements are compared in the tables below. It can be seen that the Indications for Use Statements of the Subject and Primary Predicate devices are identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC. All other reference devices have minor changes in wording, but nothing that affects the intended use or safety and effectiveness of the subject device system. | | Osstem Abutment System | OSSTEM Implant System -<br>Abutment | Link Abutment for CEREC | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | Proposed | Predicated (K161689) | Referenced (K160519) | | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | | Indications for<br>Use Statement | Osstem Abutment System is<br>intended for use with a dental<br>implant to provide support<br>for prosthetic restorations<br>such as crowns, bridges, or<br>overdentures.<br>• Link Abutment for CEREC<br>The Link Abutment for<br>CEREC is titanium alloy<br>abutments placed onto<br>OSSTEM dental implants to<br>provide support for<br>customized prosthetic<br>restorations. Link Abutment<br>for CEREC is indicated for<br>screw-retained single tooth or<br>cement-retained single tooth<br>and bridge restorations. All<br>digitally designed copings<br>and/or crowns for use with<br>the Link abutment for<br>CEREC is to be scanned | The OSSTEM Implant<br>System - Abutment is<br>intended for use with a dental<br>implant to provide support<br>for prosthetic restorations<br>such as crowns, bridges, or<br>overdentures. | The Link Abutment for<br>CEREC is titanium alloy<br>abutments placed onto<br>HIOSSEN dental implants to<br>provide support for<br>customized prosthetic<br>restorations. Link Abutment<br>for CEREC is indicated for<br>screw-retained single tooth or<br>cement-retained single tooth<br>and bridge restorations. All<br>digitally designed copings<br>and/or crowns for use with<br>the Link abutment for<br>CEREC is to be scanned<br>using Sirona CEREC AC or<br>CEREC AF or CEREC AI,<br>designed using Sirona inLab<br>software (Version 3.65) or<br>Sirona CEREC Software<br>(Version 4.2) and<br>manufactured using a Sirona<br>CEREC or inLab MC X or | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the "M" in "OSSTEM." 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com | using Sirona CEREC AC or<br>CEREC AF or CEREC AI,<br>designed using Sirona inLab<br>software (Version 3.65) or<br>Sirona CEREC Software<br>(Version 4.2) and<br>manufactured using a Sirona<br>CEREC or inLab MC X or<br>MC XL milling unit.<br>CAD/CAM<br>manufacturing/milling occurs<br>at dental laboratories per the<br>design limitations of the<br>Sirona CEREC. | MC XL milling unit.<br>CAD/CAM<br>manufacturing/milling occurs<br>at dental laboratories per the<br>design limitations of the<br>Sirona CEREC. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| Except for them, the subject devices are substantially equivalent in indications and design principles to the predicate devices as shown below. | | Transfer Abutment | Transfer Abutment | Remark | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | 510(k) No. | Proposed | Predicated (K161689) | - | | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical | | Design | Image: Transfer Abutment | Image: Transfer Abutment | Identical | | Indications for Use<br>Statement | The Osstem Abutment System<br>is intended for use with a<br>dental implant to provide<br>support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | The OSSTEM Implant System<br>- Abutment is intended for use<br>with a dental implant to<br>provide support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | Identical | | Principle of<br>Operation | Using making for general<br>cement-type prosthesis. | Using making for general<br>cement-type prosthesis. | Identical | | Material | Titanium Alloy<br>(Ti-6Al-4V, ASTM F136) | Titanium Alloy<br>(Ti-6Al-4V, ASTM F136) | Identical | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern. | | D(Ø) | G/H | Post | | D(Ø) | G/H | Post | | | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------|--|------|------------------|--------------|--------------------------------------------------|--| | Dimension (mm) | 4 | 1, 2, 3, 4,<br>5, 6, 7 | 5.5, 7 | | | | | -. Addition of Ø4<br>(New, smallest<br>diameter) | | | | 4.6 | 6, 7 | 5.5, 7 | | 4.6 | 1, 2, 3, 4,<br>5 | 5.5, 7 | -. Addition of Ø4.6<br>(G/H 6, 7mm) | | | | 5 | 6, 7 | 4, 5.5,<br>7 | | 5 | 1, 2, 3, 4,<br>5 | 4, 5.5,<br>7 | -. Addition of Ø5<br>(G/H 6, 7mm) | | | | 6 | 6, 7 | 4, 5.5,<br>7 | | 6 | 1, 2, 3, 4,<br>5 | 4, 5.5,<br>7 | -. Addition of Ø6<br>(G/H 6, 7mm) | | | | 7 | 1, 2, 3, 4,<br>5, 6, 7 | 4 | | | | | -. Addition of Ø7<br>(Post 4mm) | | | | 7 | 6, 7 | 5.5 | | 7 | 1, 2, 3, 4,<br>5 | 5.5 | -. Addition of Ø7<br>(G/H 6, 7mm) | | | S.E. | Similarities<br>Proposed Transfer Abutment has same design, function and indications for use<br>statement; and is made with same material with same manufacturing method by same<br>manufacturer and is generally used for cement-retained restoration compared to that of<br>the predicated Transfer Abutment (K161689).<br>Differences<br>The proposed Transfer Abutment has diameter of 4.0 to 7.0mm that has smallest<br>diameter among the proposed and the predicated Transfer Abutment (K161689).<br>However, the proposed abutment is straight type; therefore, we do not consider<br>additional fatigue testing.<br>.. Except for its size of diameter, proposed Transfer Abutment and the predicated<br>Transfer Abutment have common in design, function, indication for use, material,<br>manufacturing process, manufacturer, etc.; therefore, the proposed Transfer Abutment is<br>substantially equivalent to the predicated Transfer Abutment (K161689). | | | | | | | | | | | Angled Abutment | Angled Abutment | Remark | |----------------------------------|----------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------| | 510(k) No. | Proposed | Predicated (K120847) | - | | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical | | Design | Image: Angled abutment with TiN Coating | Image: Angled abutment with TiN Coating | Identical except for<br>its TiN coating<br>section | | Indications for Use<br>Statement | The Osstem Abutment System<br>is intended for use with a | The abutment is intended for<br>use with a dental implant | Identical | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to it. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name. | | dental implant to provide<br>support for prosthetic<br>restorations such as crowns,<br>bridges, or overdentures. | fixture to provide support for<br>prosthetic restorations such as<br>crowns, bridges, or<br>overdenture. | | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Principle of<br>Operation | Using making general cement-<br>type prosthesis when a<br>prosthetic's path adjustment is<br>necessary. | Using making general cement-<br>type prosthesis when a<br>prosthetic's path adjustment is<br>necessary. | Identical | | Material | Titanium Alloy<br>(Ti-6Al-4V, ASTM F136)…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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