CCM Abutment System

K173120 · Innobiosurg Co., Ltd. · NHA · Mar 16, 2018 · Dental

Device Facts

• Record ID: K173120
• Device Name: CCM Abutment System
• Applicant: Innobiosurg Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Story

CCM Abutment System consists of Co-Cr-Mo alloy UCLA abutments, burn-out core cylinders/caps, and titanium alloy abutment screws; used with dental implants to support prosthetic restorations (crowns, bridges, overdentures). Device is non-sterile, intended for single use, and requires steam sterilization by the clinician. Abutments are straight (zero angulation) and designed for delayed loading. Clinicians (dentists/specialists) use the system in surgical/restorative procedures; the plastic component is burned out during casting. Output is a custom-fabricated final abutment providing structural support for the prosthesis, restoring chewing function for the patient.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -3, -5, -10, and -11. Galvanic reaction testing conducted between Co-Cr alloy and Ti Gr.5. End-user steam sterilization validation leveraged from predicate K140806 due to identical materials, manufacturing, and packaging.

Technological Characteristics

Materials: Co-Cr-Mo alloy and Poly Diacetate (burn-out components), Ti-6AL-4V Eli (screws). Principle: Screw-retained dental abutment. Dimensions: Various diameters (4.0-6.0mm) and lengths (8.5-17mm). Connectivity: None. Sterilization: Non-sterile, steam sterilization required by user. Software: None.

Indications for Use

Indicated for partially or fully edentulous patients requiring dental implant abutments for single or multiple-unit restorations, including cement-retained, screw-retained, or fixed bridgework. Contraindicated for immediate loading.

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

• IBS Implant System (K153350)

Reference Devices

• IBS Implant System (K140806)
• IBS Implant System II (K162099)
• s-Clean OneQ-SL Narrow Implant System (K161244)

Submission Summary (Full Text)

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March 16, 2018

InnoBioSurg Co., Ltd. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K173120

Trade/Device Name: CCM Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 14, 2018 Received: February 14, 2018

## Dear April 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K173120

Device Name CCM Abutment System

#### Indications for Use (Describe)

The CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including, cement retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

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)

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# 510(k) Summary

#### Submitter

InnoBioSurg Co., Ltd. Bo-reum Yoo 44-19, Techno 10-ro, Yuseong-gu, Daejeon, 34027 Republic of Korea Email: [e-mail] Tel. [phone] Fax. [phone]

### Official Correspondent

Withus Group Inc April Lee 106 Superior Irvine CA 92620 USA Email: [e-mail] Phone: [phone] Fax: [phone]

## Device Information

- Trade Name: CCM Abutment System
- Common Name: Dental Abutment System
- . Classification Name: Endosseous dental implant abutment
- Product Code: NHA
- . Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II
- Date prepared: 03/16/2018

## Primary Predicate

K153350, IBS Implant System by Innobiosurg Co., Ltd.

## Reference Predicates

- K140806,IBS Implant System by Innobiosurg Co., Ltd
- K162099, IBS Implant System II by Innobiosurg Co., Ltd.
- K161244, s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd.

## Device Description

CCM Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. CCM Abutment System consists of UCLA Abutment and titanium abutment screws. All subject abutments are intended to be cast at zero angulations and placed on dental implant bodies which do not require angle correction.

## UCLA Abutment

UCLA Abutments are pre-manufactured prosthetic abutments directly connected to the endosseous dental implant intended for permanent restoration, for either single or multiple tooth screw retained restorations. The lower part of the abutment which connects directly to the implant is made of Co-Cr-Mo alloy, and the upper part is made of plastic (Poly Diacetate). The plastic part is dissolved once the casting is done. The abutment screw is connected to the implant by a prosthetic screw, supplied with the abutment, and made of Ti-6AL-4V Eli. UCLA Abutments are intended for no angulation and straight implantation only. The abutments are supplied non-sterile, to be steam sterilized by the user according to the labeling, and intended for single use.

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## Multi-unit CCM Cylinder

Multi-unit CCM Cylinders are used in conjunction with screw retained type Abutment to provide support for screw type final prosthesis, and for fabrication of custom abutment for screw retained restorations.

The subject device is compatible with the following Implants:

| K number | Compatible Implants |
|----------|---------------------|
| K140806 | IBS Implant system |
| K152520 | Magicore System |
| K153350 | IBS Implant System |

The CCM Abutment system is provided non-sterile and packaged separately. The abutments should be sterilized before use. Abutment screw (OIAS400) was cleared from K140806.

The UCLA abutments, Burn out core cylinder and cap are not intended to be cast at angulation or placed to provide angular correction. Plastic sleeve of UCLA Abutment can replace the Non-precious metal (Co-Cr Alloy). All finished devices are final abutments.

The diameters and lengths of the CCM Abutment System are below:

## 1) UCLA Abutment

The gingival height could be 1-4mm, angulation straight only, length of abutment post of 4-10mm. Assembled torque: 30N·cm

| No | Diameter (Ø) | Cuff | Length | Remark |
|----|--------------|------|--------|-------------|
| 1 | | 1 mm | 14 mm | |
| 2 | 4 mm | 2 mm | 15 mm | |
| 3 | | 3 mm | 16 mm | |
| 4 | | 4 mm | 17 mm | |
| 5 | | 1 mm | 14 mm | |
| 6 | 4.5 mm | 2 mm | 15 mm | |
| 7 | | 3 mm | 16 mm | |
| 8 | | 4 mm | 17 mm | Hex/Non-Hex |
| 9 | | 1 mm | 14 mm | |
| 10 | 5 mm | 2 mm | 15 mm | |
| 11 | | 3 mm | 16 mm | |
| 12 | | 4 mm | 17 mm | |
| 13 | | 1 mm | 14 mm | |
| 14 | 5.5 mm | 2 mm | 15 mm | |
| 15 | | 3 mm | 16 mm | |
| 16 | | 4 mm | 17 mm | |

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## 2) Burn out core cylinder (Screw type)

No Angulation straight only, length of abutment post of 4-9mm.

#### Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|---------|-------------|
| 1 | 5 mm | 8.5 mm | Hex/Non-Hex |
| 2 | 6 mm | 8.65 mm | |

### 3) Burn out core cap (Cemented type)

No Angulation straight only, length of abutment post of 4-9mm.

## Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|---------|-------------|
| 1 | 5 mm | 9.15 mm | Hex/Non-Hex |
| 2 | 6 mm | 9.15 mm | |

## 4) Burn out core T cylinder (Screw type)

No Angulation straight only, length of abutment post of 4-9mm.

Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|----------|-------------|
| 1 | 5 mm | 10.65 mm | Hex/Non-Hex |
| 2 | 6 mm | 10.8 mm | |

## 5) Burn out core U cylinder (Screw type)

No Angulation straight only, length of abutment post of 4-9mm.

Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|----------|-------------|
| 1 | 5 mm | 12.25 mm | Hex/Non-Hex |
| 2 | 6 mm | 12.4 mm | |

## 6) Burn out core U cap (Cemented type)

No Angulation straight only, length of abutment post of 4-9mm.

Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|----------|-------------|
| 1 | 5 mm | 12.95 mm | |
| 2 | 6 mm | 12.95 mm | Hex/Non-Hex |

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## 7) Multi-unit CCM Cylinder

No Angulation straight only, length of abutment post of 4-9mm.

Assembled torque: 30N·cm

| No | Diameter (Ø) | Length | Remark |
|----|--------------|--------|-------------|
| 1 | 4.8 mm | 12 mm | Hex/Non-Hex |

## Indication for Use

The CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

## Non-Clinical Data:

The subject device was tested to evaluate its substantial equivalence according to the following standards.

- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ● ISO 10993-10:2010 and ISO 10993-11:2006.
- Galvanic Reaction Test between CoCr alloy and non-precious metal ●

Below tests were performed for predicate devices and leveraged for the subject device:

- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ● ST79 referenced in K140806
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.

Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K161244.

The galvanic reaction testing between the CoCr alloy and non-precious dental alloys, Ti Gr.5. was performed for subject device and compatible implants. As the FDA guidance of "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments", corrosion potential of each CoCr alloy and Ti Gr.5 and couple potential for assembled CoCr alloy and Ti Gr.5 were assessed.

The end user sterilization test was performed for predicate device, K140806 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate, K140806.

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

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# Comparison to Predicate Devices:

| UCLA Abutment | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Subject device | Primary Predicate device | Reference Predicate device |
| | CCM Abutment System | IBS Implant system | s-Clean OneQ-SL Narrow Implant System |
| 510k | N/A | K153350 | K161244 |
| Part Name | UCLA Abutment<br>(Hex, Non-Hex) | UCLA Abutment | S-clean CCM Abutment<br>(Narrow) |
| Material | Co-Cr-Mo Alloy<br>Poly Diacetate | Titanium Alloy<br>Poly Diacetate | Co-Cr-Mo Alloy |
| Manufacturer | Innobiosurg Co.,Ltd | Innobiosurg Co.,Ltd | Dentis Co.,Ltd |
| Indications for use | The CCM Abutment System is<br>intended to replace missing<br>teeth to restore chewing<br>function. The CCM Abutment<br>System can be placed in<br>support of single or multiple-<br>unit restorations including;<br>cement retained, screw<br>retained, and terminal or<br>immediate abutment support<br>for fixed bridgework. This<br>system is for one or two stage<br>surgical procedures. This<br>system is intended for delayed<br>loading. | The IBS Implant System is<br>intended to replace missing<br>teeth to restore chewing<br>function. The IBS Implant<br>can be placed in support of<br>single or multiple-unit<br>restorations including;<br>cement retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>immediate abutment support<br>for fixed bridgework. This<br>system is for one or two<br>stage surgical procedures.<br>This system is intended for<br>delayed loading. | The s-Clean One-Q-SL Narrow Implant System<br>(3.0, 3.3mm) may be used as an artificial root<br>structure for single tooth replacement of<br>mandibular central and lateral incisors and<br>maxillary lateral incisors. The implants may be<br>restored immediately<br>1) with a temporary prosthesis that is not in<br>functional occlusion,<br>2) when splinted together as an artificial root<br>structure for multiple tooth replacement of<br>mandibular incisors, or<br>3) for denture stabilization using multiple<br>implants in the anterior mandible and maxilla.<br>The implants may be placed in immediate<br>function when good primary stability has been<br>achieved and with appropriate occlusal loading. |
| Dimension | Ø 4mm, Ø 4.5mm, Ø 5mm, Ø<br>5.5mm (D) X 14,15,16,17 mm<br>(L) | Ø3.5mm, Ø4mm, Ø4.5mm,<br>Ø5mm, Ø5.5mm (D) X<br>14,15,16,17 mm (L) | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L) |

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| Restoration angulations | No Angle | No Angle | No Angle |
|-------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Design | | | |
| Principle of Operation | a screw retained restoration<br>type of abutment using a screw<br>to fix a prosthesis | a screw retained restoration<br>type of abutment using a<br>screw to fix a prosthesis | a screw retained restoration type of abutment<br>using a screw to fix a prosthesis |

| Burn out core cylinder (Hex and Non-Hex) | | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Subject device | Primary Predicate device | Reference Predicate device |
| | CCM Abutment System | IBS Implant system | s-Clean OneQ-SL Narrow Implant System |
| 510k | N/A | K153350 | K161244 |
| Part Name | Burn out core cylinder | UCLA Abutment | S-clean CCM Abutment<br>(Narrow) |
| Material | Co-Cr-Mo Alloy<br>Poly Diacetate | Titanium Alloy<br>Poly Diacetate | Co-Cr-Mo Alloy |
| Manufacturer | Innobiosurg Co.,Ltd | Innobiosurg Co.,Ltd | Dentis Co.,Ltd |
| Indications for use | The CCM Abutment System is<br>intended to replace missing teeth to<br>restore chewing function. The<br>CCM Abutment System can be<br>placed in support of single or<br>multiple-unit restorations<br>including; cement retained, screw<br>retained, and terminal or<br>immediate abutment support for<br>fixed bridgework. This system is<br>for one or two stage surgical | The IBS Implant System is<br>intended to replace missing teeth<br>to restore chewing function. The<br>IBS Implant can be placed in<br>support of single or multiple-unit<br>restorations including; cement<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or immediate abutment<br>support for fixed bridgework.<br>This system is for one or two | The s-Clean One-Q-SL Narrow Implant<br>System (3.0, 3.3mm) may be used as an<br>artificial root structure for single tooth<br>replacement of mandibular central and lateral<br>incisors and maxillary lateral incisors. The<br>implants may be restored immediately<br>1) with a temporary prosthesis that is not in<br>functional occlusion,<br>2) when splinted together as an artificial root<br>structure for multiple tooth replacement of<br>mandibular incisors, or |
| | procedures. This system is<br>intended for delayed loading. | stage surgical procedures. This<br>system is intended for delayed<br>loading. | 3) for denture stabilization using multiple<br>implants in the anterior mandible and<br>maxilla.<br>The implants may be placed in immediate<br>function when good primary stability has<br>been achieved and with appropriate occlusal<br>loading. |
| Principle of<br>Operation | a screw retained restoration type of<br>abutment using a screw to fix a<br>prosthesis | a screw retained restoration type<br>of abutment using a screw to fix a<br>prosthesis | a screw retained restoration type of abutment<br>using a screw to fix a prosthesis |
| Hex | | | |
| Dimension | Ø 5mm, Ø 6mm (D) X 8.5, 8.65<br>mm (L) | Ø3.5mm, Ø4mm, Ø4.5mm,<br>Ø5mm, Ø5.5mm (D) X<br>14,15,16,17 mm (L) | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L) |
| Restoration<br>angulations | No Angle | No Angle | No Angle |
| Design | Image: abutment | Image: abutment | Image: abutment |
| Non-Hex | | | |
| Dimension | Ø 5mm, Ø 6mm (D) X 8.5, 8.65<br>mm (L) | Ø3.5mm, Ø4mm, Ø4.5mm,<br>Ø5mm, Ø5.5mm (D) X<br>14,15,16,17 mm (L) | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L) |
| Restoration<br>angulations | No Angle | No Angle | No Angle |
| Design | Image: abutment | Image: abutment | Image: abutment |
| Burn out core cap | | | |
| Device Name | Subject device | Primary Predicate device | Reference Predicate device |
| | CCM Abutment System | IBS Implant system | s-Clean OneQ-SL Narrow Implant System |
| 510k | N/A | K153350 | K161244 |
| Part Name | Burn out core cap | UCLA Abutment | S-clean CCM Abutment<br>(Narrow) |
| Material | Co-Cr-Mo Alloy<br>Poly Diacetate | Titanium Alloy<br>Poly Diacetate | Co-Cr-Mo Alloy |
| Manufacturer | Innobiosurg Co.,Ltd | Innobiosurg Co.,Ltd | Dentis Co.,Ltd |
| Indications for use | The CCM Abutment System is<br>intended to replace missing teeth<br>to restore chewing function. The<br>CCM Abutment System can be<br>placed in support of single or<br>multiple-unit restorations<br>including; cement retained,<br>screw retained, and terminal or<br>immediate abutment support for<br>fixed bridgework. This system is<br>for one or two stage surgical<br>procedures. This system is<br>intended for delayed loading. | The IBS Implant System is intended<br>to replace missing teeth to restore<br>chewing function. The IBS Implant<br>can be placed in support of single or<br>multiple-unit restorations including;<br>cement retained, screw retained, or<br>overdenture restorations, and<br>terminal or immediate abutment<br>support for fixed bridgework. This<br>system is for one or two stage<br>surgical procedures. This system is<br>intended for delayed loading. | The s-Clean One-Q-SL Narrow Implant<br>System (3.0, 3.3mm) may be used as an<br>artificial root structure for single tooth<br>replacement of mandibular central and lateral<br>incisors and maxillary lateral incisors. The<br>implants may be restored immediately<br>1) with a temporary prosthesis that is not in<br>functional occlusion,<br>2) when splinted together as an artificial root<br>structure for multiple tooth replacement of<br>mandibular incisors, or<br>3) for denture stabilization using multiple<br>implants in the anterior mandible and maxilla.<br>The implants may be placed in immediate<br>function when good primary stability has been<br>achieved and with appropriate occlusal<br>loading. |
| Principle of<br>Operation | a screw retained restoration type<br>of abutment using a screw to fix<br>a prosthesis | a screw retained restoration type of<br>abutment using a screw to fix a<br>prosthesis | a screw retained restoration type of abutment<br>using a screw to fix a prosthesis |
| Hex | | | |
| Dimension | Ø 5mm, Ø 6mm (D) X 9.15 mm<br>(L) | Ø3.5mm, Ø4mm, Ø4.5mm, Ø5mm,<br>Ø5.5mm (D) X 14,15,16,17 mm (L) | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L)…