← Product Code [NHA](/productcode/NHA) · K232220 # SS Abutment System (K232220) _Osstem Implant Co., Ltd. · NHA · Dec 5, 2023 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K232220 ## Device Facts - **Applicant:** Osstem Implant Co., Ltd. - **Product Code:** [NHA](/productcode/NHA.md) - **Decision Date:** Dec 5, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use 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 SS Abutment System consists of various dental abutments (ComOcta Plus, ComOcta Milling, Port, O-ring) and closing screws used to support prosthetic restorations on dental implants. The system is made of titanium alloy (ASTM F136) or Titanium Grade 3/4 (ASTM F67). The ComOcta Milling Abutment is designed for chairside modification by a clinician. The system is used by dental professionals in a clinical setting to connect to an endosseous dental implant fixture. The abutments provide the interface for crowns, bridges, or over-dentures. The device components are provided sterile via gamma irradiation. The system is intended to provide stable support for dental prosthetics, benefiting patients by restoring oral function and aesthetics. ## Clinical Evidence No clinical studies were submitted. Substantial equivalence is supported by non-clinical performance data, including biocompatibility evaluation based on predicate history, mechanical property assessment per ISO 14801, and MRI compatibility assessment based on scientific rationale and published literature. ## Technological Characteristics Materials: Titanium Alloy (ASTM F136), Titanium Grade 3/4 (ASTM F67), POM (Polyoxymethylene). Principle: Endosseous dental implant abutment. Form factor: Various diameters and lengths for specific prosthetic applications. Connectivity: Mechanical connection to dental implant fixture. Sterilization: Gamma irradiation. Software: None. ## Regulatory 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/SS/GS System ([K160670](/device/K160670.md)) ## Reference Devices - Osstem Abutment System ([K182091](/device/K182091.md)) - SS System ([K062051](/device/K062051.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. December 5, 2023 Osstem Implant Co., Ltd. % Peter Lee RA/OA Manager HioSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030 Re: K232220 Trade/Device Name: SS Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 31, 2023 Received: November 2, 2023 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. {2}------------------------------------------------ 3 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, Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232220 Device Name SS Abutment System #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| |
☑ Prescription Use (Part 21 CFR 801 Subpart D)
|
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Implant Co., Lt g-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com ## 510(k) Summary K232220 ### Date: December 5, 2023 ### 1. Company and Correspondent making the submission | - | Submitter's Name | : | Osstem Implant Co., Ltd. | |---|----------------------|---|--------------------------------------------------------------------------------| | - | Address | : | 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan,
48002, Republic of Korea | | - | Contact | : | Ms. Seungju Kang | | - | Phone | : | +82-51-850-2500 | | - | Correspondent's Name | : | Hiossen Inc. | | - | Address | : | 85 Ben Fairless Dr. Fairless Hills, PA 19030 | | - | Contact | : | Mr. Peter Lee | | - | Phone | : | +1-267-759-7031 | #### 2. Proposed Device | - Trade or (Proprietary) Name | : SS Abutment System | |-------------------------------|--------------------------------------| | - Classification Name | : Endosseous dental implant Abutment | | - Regulation Number | : 21 CFR 872.3630 | | - Devce Classification | : Class II | | - Classification Product Code | : NHA | ## 3. Predicated and Reference Devices | Primary Predicate | | |-------------------|------------------------| | K160670 | US/SS/GS System | | Reference Device | | | K182091 | Osstem Abutment System | | K062051 | SS System | ### 4. Indication for use 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. ## 5. Device Description SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a stylized font, with the word "IMPLANT" written in a smaller font below it. The logo is simple and clean, and it is likely used to represent the company and its products. Osstem Implant Co., Ltd. 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 SS Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics. | Device | | Content | |--------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ComOcta Plus Abutment | Description | It is used for making general cement- retained/combination prosthesis and used for thick gingiva or deeply placed implant. | | | Material | Ti-6Al-4V (ASTM F136), TiN Coating | | | Diameter (D) and Length (L) | Ø5.5 x L 5, 6, 7, 7.5, 8, 9.5 | | | | Ø6.0 x L 7.5 | | | | Ø6.5 x L 5, 6, 7, 8, 8.5, 10 | | | | Ø6.8 x L 7.5 | | | | Ø7.0 x L 9.5 | | | | Ø7.2 x L 8.5
Ø7.6 x L 9.5 | | ComOcta Milling Abutment | Description | It is used as cement/combination-retained prosthesis and it is used when the abutment's margin shape needs corrections. This device is intended to be modified chairside by the clinician. | | | Material | Ti-6Al-4V (ASTM F136) | | | Diameter (D) and Length (L) | Ø5.5 x L 14 | | | | Ø6.5 x L 14.35 | | ComOcta Protect Cap | Description | It is made of plastic material and formed with a cover cap to protect porous upper structure. | | | Material | POM | | | Diameter (D) and Length (L) | Ø5.3 x L 6.35, 7.85, 9.35 | | Port Abutment | Description | Port Abutment is used for prosthetic restoration. It is for implant retained overdenture at maxilla/mandible in case of the patient has no teeth. | | | Material | Ti-6Al-4V (ASTM F136), TiN Coating | | | Diameter (D) and Length (L) | Ø6.06 x L 3.5, 4.5, 5.5, 6.5 | | | | | | O-ring Abutment | Description | It is used for overdenture with O-ring attachment. | | | Material | Ti-6Al-4V (ASTM F136) | | | Diameter (D) and Gingiva Height (G/H) | Ø4.3 x G/H 0, 2, 4 | | | | | | | Material | Titanium Gr 3 (ASTM F67) | | | Diameter (D) and Length (L) | Ø4.8 x L 8.2
Ø6.0 x L 8.2 | | | | | | Closing Screw | Description | It is used to protect the exposed platform of the implant during healing period | | | Material | Titanium Gr 4 (ASTM F67) | | Diameter (D) and
Length (L) | $\text{\O}3.5$ x L 6.0
$\text{\O}4.3$ x L 6.4 | | The specifications of the proposed device are as follow; {6}------------------------------------------------ Image /page/6/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, lighter font. The logo is simple and modern, and it is likely used to represent the company's brand. Osstem Implant Co., Ltd 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 Matrix These subject devices are cleared in past 510(k); therefore, indication for use, shape, connection structure, material, surface treatment, manufacturer and etc. are the same with predicated devices except dimension of additional products. | | Subject Device | Primary Predicate Device | Remark | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Device Name | ComOcta Plus Abutment | ComOcta Plus Abutment | Same | | 510(k)
Number | - | K160670 | - | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | | Design | Image: Two ComOcta Plus Abutments | Image: Two ComOcta Plus Abutments | Same | | Indication for
Use | 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. | 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. | Same | | Principle 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 | Same | | Diameter (D)
and Length
(L) | Ø5.5 x L 5, 6, 7, 7.5, 8, 9.5
Ø6.0 x L 7.5
Ø6.5 x L 5, 6, 7, 8, 8.5, 10
Ø6.8 x L 7.5
Ø7.0 x L 9.5
Ø7.2 x L 8.5
Ø7.6 x L 9.5 | Ø5.5 x L 6.5, 7.5, 8.5, 9.5
Ø6.5 x L 6.5, 7.5, 8.5, 9.5 | Different | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | | S.E. | Similarities
Proposed ComOcta Plus Abutment has same design, function and indication for
use; and is made with same material with same manufacturing process by same
manufacturer compared to that of the predicate ComOcta Plus Abutment,
K160670. | | | {7}------------------------------------------------ Image /page/7/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, lighter font. The logo is simple and modern. **Osstem Implant Co., Ltd.** OSSTEM Implant Co., Ltd., Ltd., Ltd., 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 | Differences
The diameter Ø5.5 ~ Ø7.6 of proposed device differs from predicate device; but is
included in the dimension range of the predicate device, except for the larger
diameters Ø6.8 ~ Ø7.6. But they are larger than predicate device, so it is
considered to have equal to or greater performance than that of the predicate
device. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The diameter Ø5.5 and Ø6.5 of proposed device are same and there is only
difference in the length 5mm and 6mm which is smaller than the predicate device.
However, proposed device has same design, function, connection and platform etc
as predicate deivce. In addition, since proposed device is straight type and the
distance between the embedding plane and the centre of the hemispherical hoading
member always is 11mm according to the ISO 14801, it has same moment arm. | | As a result, the fatigue of the proposed device is considered to be equal to or
greater than that of the predicate device. Therefore, we don't conduct additional
fatigue testing. | | : Proposed ComOcta Plus Abutment and the predicate device have common in
design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed device is substantially equivalent to the
predicate device. | - | | Subject Device | Predicate Device | Remark | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Device Name | ComOcta Milling Abutment | ComOcta Plus Abutment | Different | | 510(k)
Number | - | K160670 | - | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | | Design | Image: ComOcta Milling Abutment | Image: ComOcta Plus Abutment | Different | | Indication for
Use | 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. | 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. | Same | | Principle of
Operation | As general cement retained
restoration, it is connected with | As general cement retained
restoration, it is connected with | Same | {8}------------------------------------------------ Image /page/8/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, sans-serif font. The logo is simple and modern. **Osstem Implant Co., Ltd.** Osstem Implant Co., و Ltd. 66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com | | fixture and cemented crown on
the abutment | fixture and cemented crown on
the abutment | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------| | Diameter (D)
and Length
(L) | Ø5.5 x L 14
Ø6.5 x L 14.35 | Ø5.5 x L 6.5, 7.5, 8.5, 9.5
Ø6.5 x L 6.5, 7.5, 8.5, 9.5 | Different | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | | S.E. | Similarities
Proposed ComOcta Milling Abutment has same function and indication for use;
and is made with same material with same manufacturing process by same
manufacturer compared to that of the predicated ComOcta Plus Abutment,
K160670.

Differences
The length 14mm and 14.35mm of proposed device is not included in dimension
range of predicate device. However, the diameter range of proposed device is
same as predicate device, and since the proposed device is compatible with the
same implant as predicate device, it has same design, function, connection and
platform etc as predicate deivce. In addition, since proposed device is straight type
and the distance between the embedding plane and the centre of the hemispherical
hoading member always is 11mm according to the ISO 14801, it has same
moment arm.

As a result, the fatigue of the proposed device is considered to be equal to or
greater than that of the predicate device. Therefore, we don't conduct additional
fatigue testing.

The ComOcta Milling Abutment can be modified chairside by hand, to a
minimum post height 4mm, and a gingival height between 1mm and 3mm, with
no angulation allowed. These dimensions are not significantly different compared
to the predicate device and do not present a new worst case for performance
testing. In addition, proposed ComOcta Milling Abutment and the predicate
ComOcta Plus Abutment have common in design, function, indications for use,
material, manufacturing process, manufacturer, etc.; therefore, the proposed | | | | | Subject Device | Predicate Device | Remark | |------------------|-------------------------|-------------------------|-----------| | Device Name | ComOcta Protect Cap | ComOcta Retraction Cap | Different | | 510(k)
Number | - | K160670 | - | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | {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 a smaller, gray font below it. There is a small circle to the right of the word "OSSTEM". **sstem Implant Co., Ltd.** Osstem Implant Co., و Ltd. 66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com | Design | Image: cap | Image: cap | Different | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Indication for
Use | 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. | 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. | Same | | Principle of
Operation | ComOcta Protect Cap is
temporary connected with
ComOcta abutment for minimize
foreign body sensation by the
patient | ComOcta Retraction Cap is
temporary connected with
ComOcta abutment for minimize
foreign body sensation by the
patient and accurate margin
impression function when taking
impression directly from a
ComOcta abutment. | Same | | Diameter (D)
and Length
(L) | Ø5.3 x L 6.35, 7.85, 9.35 | Ø6.4 x L 6.25, 7.75, 9.25
Ø7.7 x L 6.1, 7.6, 9.1 | Different | | Material | POM | POM | Same | | | Similarities
Proposed ComOcta Protect Cap has same function, indication for use; and is made
with same material with same manufacturing process by same manufacturer
compared to that of the predicated ComOcta Retraction Cap, K160670.

Differences
The diameter Ø5.3 of proposed device is smaller than that of predicate device and
the length 6.35 ~ 9.35mm of proposed device differs from predicate device.
Although there are differences in dimension range and feature, proposed device
has same compatible device, ComOcta Abutment, and principle of operation with
predicate device. In addition, proposed device is made of POM
(Polyoxymethylene) which is same raw material of predicate device.

... Proposed ComOcta Protect Cap and the predicated device have common in
design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed device is substantially equivalent to the
predicated device. | | | | | Subject Device | Reference Device | Remark | |-------------|----------------|------------------|--------| | Device Name | Port Abutment | Port Abutment | Same | {10}------------------------------------------------ Image /page/10/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, sans-serif font. The logo is simple and modern. Osstem Implant Co., Ltd.. 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 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)
Number | - | K182091 | - | |-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | | Design | Image: Prosthetic system | Image: Abutment System | Same | | Indication for
Use | 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. | The Osstem Abutment System is
intended for use with a dental
implant to provide support for
prosthetic restorations such as
crowns, bridges, or overdentures. | Same | | Principle of
Operation | Using making implant retained
overdenture at maxilla/mandible. | Using making implant retained
overdenture at maxilla/mandible. | Same | | Diameter (D)
and Length
(L) | $Ø$ 6.06 x L 3.5, 4.5, 5.5, 6.5 | $Ø$ 4.8 x L 2.5, 3.5, 4.5, 5.5, 6.5 | Different | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | | S.E. | Similarities
Proposed Port Abutment has same design, function and indication for use; and is
made with same material with same manufacturing process by same manufacturer
compared to that of the reference device Port Abutment, K182091.
Differences
The only difference is that the proposed device has a diameter $Ø$ 6.06 compared to
the reference device diameter $Ø$ 4.8. However, added diameter is bigger than
reference device and the lengths 3.5~6.5mm is same as the range of reference
device. In addition, proposed device is straight type and is not received single load
because this is used for making overdenture that means load is dispersed to the
full denture. Therefore, we don't consider additional fatigue testing.
. . Proposed Port Abutment and the predicate device have common in design,
function, indications for use, material, manufacturing process, manufacturer, etc.;
therefore, the proposed device is substantially equivalent to the predicate device. | | | | | Subject Device | Reference Device | Remark | |---------------|-------------------------|-------------------------|--------| | Device Name | O-ring Abutment | O-ring Abutment | Same | | 510(k) Number | - | K062051 | - | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. The logo is simple and modern. **Osstem Implant Co., Ltd.** Osstem Implant Co., و Ltd. 66-16, Bansong-ro 513beon-gil, Haundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com | Design | Image: Prosthetic system design 1 | Image: Prosthetic system design 2 | Same | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Indication for
Use | 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. | SS system in indicated 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. SS
System is for single stage surgical
procedures | Same | | Principle of
Operation | Using making stud type
overdenture prosthetics. | Using making stud type
overdenture prosthetics. | Same | | Diameter (D)
and Gingiva
Height (G/H) | $Ø4.3$ x G/H 0, 2, 4 | $Ø3.5$ x G/H 0, 2, 4 | Different | | Material | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Same | | S.E. | Similarities
Proposed O-ring Abutment has same design, function and indication for use; and
is made with same material with same manufacturing process by same
manufacturer compared to that of the reference O-ring Abutment, K062051.
Differences
The only difference is that the proposed device has a diameter $Ø4.3$ compared to
the reference device diameter $Ø3.5$ . However, added diameter is bigger than
reference device and the gingiva height 0~4mm is same as the range of predicate
device. In addition, proposed device is straight type and is not received single load
because this is used for making overdenture that means load is dispersed to the
full denture. Therefore, we don't consider additional fatigue testing.
. . Proposed O-ring Abutment and the predicate device have common in design,
function, indications for use, material, manufacturing process, manufacturer, etc.;
therefore, the proposed device is substantially equivalent to the predicate device. | | | | | Subject Device | Reference Device | Remark | | Device Name | Closing Screw | Closing Screw | Same | | 510(k) Number | - | K062051 | - | | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Same | | Design | Image: dental implant… --- **Source:** [https://fda-staging.innolitics.com/device/K232220](https://fda-staging.innolitics.com/device/K232220) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com