(336 days)
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.
This document is a 510(k) Premarket Notification of the OSSTEM Implant System - Abutment, indicating it is a dental device and not an AI/ML medical device. Therefore, the information requested in the prompt, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria, cannot be fully provided from this document.
The document discusses the substantial equivalence of the OSSTEM Implant System - Abutment to predicate devices. This typically involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, design comparisons, and performance testing for mechanical properties and biocompatibility, rather than clinical studies or performance against defined efficacy metrics tied to patient outcomes.
However, I can extract information related to the device and the type of testing performed that is relevant to its acceptance for market.
Here's a breakdown based on the provided text, addressing the points of your prompt where applicable, and highlighting what's not present due to the nature of the device:
Device Description: The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutments, components, and Abutment Screws.
Acceptance Criteria and Device Performance (General):
For this type of device, "acceptance criteria" revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. This means proving the new device is as safe and effective as the predicate. The performance is assessed through:
- Material composition: Comparing the materials used (e.g., Titanium Alloy, Zirconia, PEEK, PC, POM).
- Design and dimensions: Comparing the shapes, diameters, and lengths.
- Intended use: Confirming the device serves the same purpose.
- Technological characteristics: Ensuring the fundamental mechanism of action is similar.
- Nonclinical testing: Biocompatibility, sterilization validation, and mechanical properties.
Table of Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) for a non-AI/ML device):
| Acceptance Criteria Category | Specific Criteria (Inferred for a Dental Abutment) | Reported Device Performance (as demonstrated by comparison to predicates) |
|---|---|---|
| Intended Use | Must be for use with dental implants to support prosthetic restorations. | Identical to predicate devices for all components. (e.g., page 7: "Indication for use of subject device is slight differences in phrase with predicate but fundamental Indication is same") |
| Materials | Must use materials with established biocompatibility and mechanical properties for dental implants. | Identical to predicate devices (e.g., Titanium Alloy (Ti-6Al-4V), Zirconia, PEEK, PC, POM), or demonstrating equivalence if slight variations exist. (e.g., page 7: "Material: Zirconia, Identical"; page 8: "Material: Titanium Alloy PEEK, Identical") |
| Design/Dimensions | Must be geometrically compatible with specified implant systems and suitable for intended restorations. | Substantially Equivalent or Identical designs and dimensions. Some new dimensions are added but fall within accepted ranges, or minor cosmetic/functional modifications are made that do not raise new safety/effectiveness questions. (e.g., page 7 "Connection structure is different (Hex and Non-Hex) but Design is Substantial Equivalence"; page 8 "Diameter 4.0mm is added"; page 9 "Design is Substantial Equivalence With highlighted predicate with red Box") |
| Technological Characteristics | Must function physically in a manner similar to predicate dental abutments (e.g., cement-retained, screw-retained). | Identical to predicate devices (e.g., page 7 "Use for making general cement-type prosthesis. Identical"; page 8 "Cement retained restoration. Capable of altering/removing shape of plastic material. Two piece (Abutment + Screw) Identical") |
| Biocompatibility | Must be biocompatible, as per ISO 10993 standards. | Relying on identical materials and manufacturing processes as previously cleared predicate devices. "Therefore, no additional testing is necessary." (page 11) |
| Sterilization | Must be able to be sterilized to an appropriate Sterility Assurance Level (SAL). | For Custom Healing Abutment, leveraged data from predicate device (ISO 11137-1, -2, -3 and shelf life testing). For other non-sterile devices, steam sterilization validation conducted per ISO 17665-1 and -2. (page 11) |
| Mechanical Performance | Must withstand normal forces and maintain integrity in the oral cavity. Generally, this would be mechanical testing. | The document does not explicitly detail the mechanical performance results in a table format, but states that the device is "substantially equivalent in design, function and intended use" to predicates. This implies mechanical performance is considered equivalent due to material and design similarity, and potentially prior testing on the predicate devices. The listed nonclinical tests (like "tensile test (ASTM F882), seal peel test (ASTM F88/EN868-5), burst test (ASTM F1140), dye penetration (ASTM F1929), bubble test (ASTM F2096)") mentioned under sterilization validation are related to packaging and sterility, not the inherent mechanical strength of the abutment itself, which would be covered by separate mechanical testing for dental implants if required for initial approval. For this 510(k), they rely on the substantial equivalence premise. |
Here's how the remaining points of your prompt are addressed:
-
Sample sized used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of an AI/ML algorithm's test set. The "testing" here refers to nonclinical lab tests and comparison to predicates.
- Data provenance: Not directly applicable. The "data" are internal company reports demonstrating compliance with standards or comparisons to their own previously cleared devices. The manufacturer is OSSTEM Implant Co., Ltd. and their correspondent is HIOSSEN Inc., based in Republic of Korea and Pennsylvania, USA, respectively. The data are typically generated in a prospective manner for regulatory submission (i.e., tests are performed specifically for the submission).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device, not an AI/ML algorithm requiring ground truth from experts for image interpretation or diagnosis.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to consolidating expert opinions for ground truth in AI/ML performance studies.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done, as this is not an AI/ML device. The document explicitly states: "No clinical studies are submitted." (page 12)
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this device, "ground truth" is embodied by established engineering specifications, material properties, and performance benchmarks for dental implants, which are verified through nonclinical laboratory testing against international standards (e.g., ISO, ASTM) and comparison to predicate device characteristics.
-
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of conventional physical device.
-
How the ground truth for the training set was established:
- Not applicable. (See #7).
Summary of Acceptance:
The device's acceptance (clearance) by the FDA is based on demonstrating substantial equivalence to existing predicate devices (listed in section 3 and 6) in terms of:
- Indications for Use: Identical.
- Technological Characteristics: Very similar, with minor differences in design/dimensions that do not raise new safety/effectiveness concerns.
- Materials: Identical.
- Performance (Nonclinical): Biocompatibility is leveraged from predicate devices; sterilization validated according to relevant ISO standards.
The document explicitly states: "No clinical studies are submitted." This reinforces that the acceptance was based on nonclinical testing and comparison to predicates, as is common for many Class II medical devices in the 510(k) pathway.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2017
OSSTEM Implant Co., Ltd. c/o Mr. David Kim Manager HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030
Re: K161689
Trade/Device Name: OSSTEM Implant System - Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 21, 2017 Received: April 21, 2017
Dear Mr. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Image /page/1/Picture/8 description: The image contains a signature of a person named Tina Kiang. The signature is written in cursive and is accompanied by a dash and the letter 's' below the last name. The signature is placed over a light blue watermark of the letters 'FDA'.
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
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Image /page/2/Picture/1 description: This image contains the logo and contact information for OSSTEM Implant Co., Ltd. The logo features the company name in bold, black letters, with the word "OSSTEM" in orange on the left. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea. The image also includes the telephone number (+82 51 850-2500), fax number (+82 51 850-4341), and website address (www.osstem.com).
Indications for Use Statement
161689 510(k) Number K
Device Name: OSSTEM Implant System - Abutment
Indication for use:
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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)
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OSSTEM
IMPLANT
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: May 19, 2017
- Submitter's Name:
- Address:
- Contact:
- Phone:
- Correspondent's Name:
- Address:
- Contact:
- Phone:
-
- Device:
Trade or (Proprietary) Name: Common or usual name: Classification Name: Regulation Number: Device Classification: Subsequent Product Code:
OSSTEM Implant Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002 Republic of Korea Mr. Hee Kwon Son +82 51 850 2575
HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 DAVID KIM 267 759 7031
OSSTEM Implant System - Abutment Dental Abutment Endosseous dental implant abutment 21CFR872.3630 Class II NHA
-
- Predicate Device:
Substantial equivalence is claimed to the following devices:
- Predicate Device:
Primary Predicate K130662, ET Prosthetic System, OSSTEM IMPLANT CO., LTD
Reference predicate K120847, ET SS Implant System, OSSTEM IMPLANT CO., LTD K081786, Ziocera & Convertible System, OSSTEM IMPLANT CO., LTD K121585, TS Implant System, OSSTEM IMPLANT CO., LTD K063861, GS System, OSSTEM IMPLANT CO., LTD K110308, Prosthrtic System K100245, HS, HG Prosthetic System K140507, Hiossen Prosthetic system K062051, SS System
-
- Description:
The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.
- Description:
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Image /page/4/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and black. The word "OSSTEM" is in orange, and the word "IMPLANT" is in black. The logo is simple and modern.
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
The OSSTEM Implant System - Abutment 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 OSSTEM Implant System - Abutment is substantially equivalent in design, function and intended use to the Predicate Devices as above.
This submission includes straight abutments only that are not intended for any divergence/implant body angulation correction. The abutments are to be used with the TS SA Fixtures cleared in K121995.
| Items | Content | ||
|---|---|---|---|
| 1) | Transfer Abutment | Material | Titanium Alloy (Ti-6Al-4V) |
| Diameter (mm) | 4.6, 5.0, 6.0, 7.0 | ||
| Length(mm) | 7.5, 8.5, 9, 9.1, 9.5, 10, 10.1, 10.5, 10.6, 11, 11.1,11.5, 11.6, 12, 12.1, 12.5, 12.6, 13, 13.1, 13.5,13.6, 14, 14.5, 14.6 | ||
| Angulation | - | ||
| DeviceDescription | Used for making general cement-type prosthesis. | ||
| 2) | ZioCera Abutment | Material | Zirconia |
| Diameter (mm) | 4.5, 5.5, 6.5 | ||
| Length(mm) | 12.3, 12.7, 12.75, 13, 14.2, 14.4, 14.5, 14.75, 14.8 | ||
| Angulation | - | ||
| DeviceDescription | Used for making general cement-type prosthesis. | ||
| 3) | Quick TemporaryAbutment | Material | Titanium Alloy(Ti-6Al-4V) +PEEK (Polyetherethereketone) |
| Diameter (mm) | 4, 4.5 | ||
| Length(mm) | 11.5 | ||
| Angulation | - | ||
| DeviceDescription | Used temporary until final prosthesis is made. | ||
| 4) | FreeForm STAbutment | Material | Titanium Alloy (Ti-6Al-4V) |
| Diameter (mm) | 4.0, 5.0, 5.5, 6.0, 7.0 | ||
| Length(mm) | 14, 14.5, 14.6 | ||
| Angulation | - | ||
| DeviceDescription | Used for making general cement-type prosthesis.Used when an abutment's path must be altered or aprosthetic's margin area must be customized. | ||
| 5) | Multi Abutment | Material | Titanium Alloy (Ti-6Al-4V) |
| Diameter (mm) | 4.8 | ||
| Length(mm) | 8.3,8.7, 9.3, 9.7, 10.3, 10.7, 11.3, 11.7, 12.3, 12.7 | ||
| Angulation | - | ||
| DeviceDescription | Used for edentulous mandible or maxilla to makefull denture. | ||
| Material | Titanium Alloy (Ti-6Al-4V) | ||
| 6) | Stud Abutment | Diameter (mm) | 3.5 |
| Length(mm) | 9.35, 9.75, 10.35, 10.75, 11.35, 11.75, 12.35, 12.75, 13.35, 13.75, 14.35, 14.75 | ||
| Angulation | - | ||
| Device Description | Used in creating stud type overdenture prosthetics. | ||
| Material | |||
| 7) | Rigid Protect Cap | Diameter (mm) | 4.4, 5.0, 5.5, 6.6, 7.4 |
| Length(mm) | 5.5, 5.7, 5.8, 5.9, 7.0, 7.2, 7.3, 8.5, 8.7, 8.8 | ||
| Angulation | - | ||
| Device Description | Used for the protection of the Rigid Abutment in the oral cavity. | ||
| Material | POM (Polyoxymethylene) | ||
| Diameter (mm) | 4.8, 6.0, 6.6, 7.7, 8.7 | ||
| 8) | Rigid Retraction Cap | Length(mm) | 5.5, 7.0, 8.5 |
| Angulation | - | ||
| Device Description | Used for the protection of the Rigid Abutment on the oral cavity. | ||
| Material | PEEK ( Polyetherethereketone) | ||
| Diameter (mm) | 7.05 | ||
| 9) | Custom Healing Abutment | Length(mm) | 7, 7.5, 9, 9.5, 11, 11.5 |
| Angulation | - | ||
| Device Description | Used to make a soft tissue shape before setting up prosthetics. | ||
| Material | Titanium Alloy (Ti-6Al-4V) | ||
| Diameter (mm) | 4.0, 4.6, 5.0, 6.0, 7.0 | ||
| Rigid Abutment | Length(mm) | 10, 10.4, 11, 11.4, 11.5, 11.9, 12, 12.4, 12.5, 12.9, 13, 13.4, 13.5, 13.9, 14, 14.4, 14.5, 14.9, 15, 15.4, 15.5, 15.9, 16, 16.4, 17, 17.4 | |
| 10) | Angulation | ||
| DeviceDescription | |||
| Material | |||
| Diameter (mm) | |||
| Temporary Abutment | Length(mm) | 13, 13.5, 13.6, 15, 15.5, 15.6 | |
| 11) | Angulation | ||
| Device Description | |||
| Material | |||
| Diameter (mm) | |||
| 12) | O-ringRetainer Cap Set | Length(mm) | Retainer Cap: 3.9/ O-Ring: 1.5mm |
| Angulation | |||
| Device Description | |||
| Material | |||
| Diameter (mm) | |||
| 13) | O-ring Retainer Set | Length(mm) | |
| Angulation | - | ||
| Device | Used for making stud-type overdenture. | ||
| Description | Retainer + O-ring | ||
| Material | Acrylonitrile & Butadiene Polymer | ||
| Diameter (mm) | 4.6 | ||
| 14) | O-ring Set | Length(mm) 1.5 | |
| Angulation | - | ||
| Device | Used for making stud-type overdenture. | ||
| Description | |||
| Material | Titanium Alloy (Ti-6Al-4V) | ||
| Diameter (mm) | 2.0, 2.05, 2.2, 2.3, 2.5 | ||
| 15) | Abutment Screw | Length(mm) 3.35, 5.6, 7.5, 8.35, 9.6, 10.2 | |
| Angulation | - | ||
| Device | Used to connect an abutment with fixture. | ||
| Description |
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Image /page/5/Picture/0 description: The image shows 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, italicized font. To the right of the word "OSSTEM" is a small superscript symbol.
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Image /page/6/Picture/1 description: The image shows 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, italicized font. 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
The OSSTEM Implant System - Abutment is compatible with TS Fixture System, K121995.
TS Fixture System (TSII SA Fixture, TSIII SA Fixture, TSIII Ultra-Wide Fixture) has two types of connection, Mini type and Regular type that are same as OSSTEM Implant System - Abutment connection structure as below dimension table.
| TS Fixture System(K121995) | Design | NominalDiameter | Diameter | Connection |
|---|---|---|---|---|
| TSII SA Fixture | Image: TSII SA Fixture | 3.5 | 3.5mm | Mini |
| 4.0 | 4.2mm | Regular | ||
| 4.5 | 4.4mm | Regular | ||
| 5.0 | 4.9mm | Regular | ||
| TSIII SA Fixture | Image: TSIII SA Fixture | 3.5 | 3.75mm, 3.77mm | Mini |
| 4.0 | 4.2mm, 4.25mm | Regular | ||
| 4.5 | 4.6mm, 4.63mm, 4.65mm | Regular | ||
| 5.0 | 5.05mm, 5.08mm, 5.1mm | Regular | ||
| TSIII SA Ultra-WideFixture | Image: TSIII SA Ultra-Wide Fixture | 6.0 | 5.92mm, 5.95mm, 6.0mm | Regular |
| 7.0 | 6.8mm | Regular |
- Indications for Use:
The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
-
- Substantial Equivalence Matrix:
Proposed devices in the this submission were all predicated by 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are
- Substantial Equivalence Matrix:
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Image /page/7/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, along with the company's address, phone number, fax number, and website. The address is 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.
the same with predicated devices except dimension of additional products and new compatibility with TS SA Fixtures – K121995.
Refer to the difference of additional products for detail as below table.
- Substantial Equivalence Matrix
| Part Name | ZioCera Abutment | ZioCera Abutment | Identity |
|---|---|---|---|
| Proposed | Predicate | ||
| 510K | - | K081786 | |
| Material | Zirconia | Zirconia | Identical |
| Design | Image: ZioCera Abutment Proposed | Image: ZioCera Abutment Predicate | Connectionstructure isdifferent (Hex andNon-Hex) butDesign isSubstantialEquivalence |
| DimensionDiameter (mm) | 4.5, 5.5, 6.5 | 4.5, 5.5, 6.5 | Diameter isidentical |
| Length of post(mm) | 7 | 7 | Identical |
| Indication foruse | The OSSTEM Implant System -Abutment is intended for usewith a dental implant to providesupport for prostheticrestorations such as crowns,bridges, or overdentures. | Ziocera & Convertible Systemsare intended for use as an aid inprosthetic restoration. | Indication for useof subject deviceis slightdifferences inphrase withpredicate butfundamentalIndication is same |
| TechnologicalCharacteristics | Use for making general cement-type prosthesis. | Use for making general cement-type prosthesis. | Identical |
| SE | ZioCera Abutment has cleared with K081786, Ziocera & Convertible System. ThereforeZioCera Abutment is resubmitted to add Hex type ZioCera AbutmentProposed ZioCera Abutment are exactly same with predicate ZioCera abutment exceptconnection structure (diameter and Length of post are also same)We state ZioCera Abutment is substantial Equivalence from predicate, ZioCera Abutment(K081786) |
| Proposed Device | Predicate Device | Identity | |
|---|---|---|---|
| Part Name | Quick Temporary Abutment | Quick Temporary Abutment | |
| 510K | - | K121585 | |
| Material | Titanium AlloyPEEK | Titanium AlloyPEEK | Identical |
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Image /page/8/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. There is a superscript "6" next to the word "OSSTEM".
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Identical |
|---|---|---|---|
| Description(Intended for use) | used to make temporaryprosthesis | used to make temporary prosthesis | Identical |
| Dimension(Diameter) | 4mm, 4.5mm | 4.5mm, 5.5mm | Diameter4.0mm isadded |
| Connection | Internal Hex Connection | Internal Hex Connection | Identical |
| TechnologicalCharacteristics | Cement retained restoration.Capable of altering/removingshape of plastic material.Two piece (Abutment + Screw) | Cement retained restoration.Capable of altering/removingshape of plastic material.Two piece (Abutment + Screw) | Identical |
| Indication for use | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | The TS Implant System isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and final or temporaryabutment support for fixedbridgework. It is intended fordelayed loading. The abutment isintended for use with a dentalimplant fixture to providesupport for prostheticrestorations such as crowns,bridges, or overdenture. | PhrasehighlightedIs Identical |
| Design | Image: Abutment | Image: Abutment | Shape ofPlasticsection(PEEK) isdifferent.Connectionstructure issame |
| SE | The Quick Temporary Abutment had been cleared with K121585 but it is beingresubmitted to add revised shape therefore Quick Temporary Abutment and Predicatedevices have same function, material, Connection structure, characteristic and intended useWe state Quick Temporary Abutment is substantial Equivalence from predicate, QuickTemporary Abutment (K121585). |
| Part Name | Proposed Device | Predicate Device | Identity |
|---|---|---|---|
| FreeForm ST Abutment | FreeForm ST Abutment | ||
| 510K | - | K120847 | |
| Material | Titanium Alloy (Ti-6Al-4V),ASTM F 136 | Titanium Alloy (Ti-6Al-4V),ASTM F 136 | Identical |
| Manufacturer | OSSTEM Implant Co., Ltd. | OSSTEM Implant Co., Ltd. | Identical |
| Description | Use for the path adjustment of | Use for the path adjustment of | Identical |
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Image /page/9/Picture/0 description: The image shows the alphanumeric string "K161689" in a clear, sans-serif font. The characters are uniformly sized and spaced, creating a balanced visual appearance. The string is presented in a straightforward manner, without any additional graphical elements or stylistic enhancements.
Image /page/9/Picture/1 description: The image contains the logo for Osstem Implant. The logo is in two lines, with the word "OSSTEM" in orange on the top line and the word "IMPLANT" in gray on the bottom line. There is a small orange circle with a white number 6 in the upper right corner of the logo.
| (Intended for use) | abutment or customization ofprosthetic margin. | abutment or customization ofprosthetic margin. | |
|---|---|---|---|
| Indication for use | The OSSTEM Implant System- Abutment is intended for usewith a dental implant toprovide support for prostheticrestorations such as crowns,bridges, or overdentures. | The ET/SS Implant System isindicated for use in partially orfully edentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and final ortemporary abutment support forfixed bridgework. It is intendedfor delayed loading. Theabutment is intended for usewith a dental implant fixtureto provide support forprosthetic restorations such ascrowns, bridges, oroverdenture. | Phrase highlightedIs Identical |
| TechnologicalCharacteristics | Use for making general cement-type prosthesis. | Use for making general cement-type prosthesis. | Identical |
| Dimension(Diameter) | 5 | 4.0, 5.0, 5.5, 6.0, 7.0 | Diameter 5mm isincluded dimensionrange of predicate |
| Lenth of post(mm) | 9, 10.5 | 9, 10.5 | Identical |
| Connection | Internal Hex Connection | Internal Hex Connection | Identical |
| Design | Image: Two abutments | Image: Three abutments with the first one highlighted with a red box | Design isSubstantialEquivalenceWith highlightedpredicate with redBox |
| SE | No changes in function and intended useDiameter and length of post are also included dimension range of predicateWe state FreeForm ST Abutment is substantial Equivalence with predicate, FreeForm STAbutment (K120847) |
| Part Name | Rigid Protect Cap | Rigid Protect Cap | Identity |
|---|---|---|---|
| Proposed | Predicate | ||
| 510K | - | K100245 | |
| Material | PC (PolyCarbonate Polymer) | PC (PolyCarbonate Polymer) | Identical |
| Design | Image: Rigid Protect Cap | Image: Rigid Protect Cap | Identical |
| Dimension(Diameter) | 4.4, 5.0, 5.5, 6.6, 7.4 | 4.4, 5.0, 5.4, 6.6, 7.4 | 5.4mm diameter ischanged to 5.5mm |
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Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a superscript "6" next to the word "OSSTEM".
| Intended foruse | Use for the protection of the rigidabutment in the oral cavity | Use for the protection of the rigidabutment in the oral cavity | Identical |
|---|---|---|---|
| S.E | No changes in function and intended useRigid Protect Cap is substantial Equivalence with predicate, Rigid Protect Cap |
| Part Name | Multi Abutment | Multi Abutment | Identity |
|---|---|---|---|
| Proposed | Predicate | ||
| 510K | - | K130662 | |
| Material | Titanium Alloy (TiN coating) | Titanium Alloy (TiN coating) | Identical |
| Design | Image: Multi Abutment Proposed | Image: Multi Abutment Predicate | Identical |
| Dimension(Diameter) | 4.8 | 4.8 | Identical |
| Intended for use | Using for edentulous mandible ormaxilla.Usually use to make full dentureScrew Retained Restoration | Using for edentulous mandible ormaxilla.Usually use to make full dentureScrew Retained Restoration | Identical |
| S.E | No changes in function and intended useTherefore Multi Abutment is substantial Equivalence with predicate, Multi Abutment |
| Product name | Identity | ||
|---|---|---|---|
| Transfer Abutment | - Transfer Abutment has cleared with K130662- Only article numbering change.- No other modifications (e.g. coating changes, design changes, additionof other models, etc.) | ||
| Stud Abutment | - Stud Abutment has cleared with K110308.- Only article numbering change.- No other modifications (e.g. coating changes, design changes, additionof other models, etc.) | ||
| Rigid Retraction Cap | - Rigid Retraction Cap has cleared with K100245.- Only article numbering change.- No other modifications (e.g. design changes, addition of other models,etc.) | ||
| Custom Healing Abutment |
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Image /page/11/Picture/1 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.
6-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea 'el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
| Rigid Abutment | - Rigid Abutment has cleared with K130662.- Only article numbering change.- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
|---|---|
| Temporary Abutment | - Temporary Abutment has cleared with K110308.- Only article numbering change.- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| O-ring Retainer Cap SetO-ring Retainer SetO-ring Set | - O-ring Retainer Cap Set, O-ring Retainer Set and O-ring Set has cleared with K140507.- Only article numbering change.- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
| Abutment Screw | - The Abutment Screw has a cleared with 510(k), K110308 and K081786.- Only article numbering change.- No other modifications (e.g. coating changes, design changes, addition of other models, etc.) |
7. Summary of nonclinical testing:
The following nonclinical testing data were provided or relied upon in support of the substantial equivalence determination.
Biocompatibility
As the material of construction, manufacturing process, chemical composition, and body contact are same as the predicate devices, ET Prosthetic System, OSSTEM Implant Co., Ltd., K130662; ET SS Implant System, OSSTEM Implant Co., Ltd., K120847; Ziocera & Convertible System, OSSTEM Implant Co., Ltd., K081786; TS Implant System, OSSTEM Implant Co., Ltd., K121585; GS System, OSSTEM Implant Co., Ltd., K063861; Prosthetic System, K110308; HS, HG Prosthetic System, K100245; and Hiossen Prosthetic System, K140507. Therefore, no additional testing is necessary. .
Sterilization Validation
For Custom Healing Abutment, it is same in material, dimension, and manufacturer with predicated Custom Healing Abutment in Hiossen Prosthetic System, K140507; and result of the sterilization validation report is leveraged that was conducted according to ISO 11137-1. ISO 11137-2 and ISO 11137-3, as well as the shelf life testing which was leveraged from K062051: tensile test (ASTM F882), seal peel test (ASTM F88/EN868-5), burst test (ASTM F1140), dye penetration (ASTM F1929), bubble test (ASTM F2096), and sterility testing (ISO 11737-2). Therefore, no additional testing is required.
Except for Custom Healing Abutment, the rest are non-sterile devices and steam sterilization validation was conducted according to ISO 17665-1 and ISO 17665-2.
8. Summary of clinical testing:
No clinical studies are submitted.
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Image /page/12/Picture/1 description: The image shows the logo for Osstem Implant. The logo is comprised of the word "OSSTEM" in orange, stacked on top of the word "IMPLANT" in gray. A small orange superscript "6" is located to the right of the word "OSSTEM".
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- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification OSSTEM CO., LTD. concludes that OSSTEM Implant System - Abutment is substantially equivalent to the predicate devices as described herein.
- Conclusions:
§ 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.)