DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS

K141457 · Dentium Co., Ltd. · NHA · Nov 12, 2014 · Dental

Device Facts

• Record ID: K141457
• Device Name: DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
• Applicant: Dentium Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Device Story

Dentium Implantium and SuperLine Abutments are prosthetic components used in dental implant procedures; they serve as the interface between an endosseous dental implant fixture and the final dental restoration. The device line includes angled screw abutments, cover screws, and various cylinders (titanium, gold, metal). These components are supplied non-sterile and must be autoclaved by the clinician prior to use. The abutments feature a universal conical connection designed to mate securely with Dentium Implantium/SuperLine fixtures. By providing a stable connection, these abutments facilitate the attachment of prosthetic teeth, aiding in the restoration of oral function and aesthetics for the patient. The device is used in a clinical setting by dental professionals.

Clinical Evidence

Bench testing only. Performance evaluated via ISO 14801 static compressive and fatigue testing (passed 5,000,000 cycles without fracture, cracks, or severe distortion). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, systemic toxicity, pyrogenicity, sensitization, and intracutaneous reactivity, confirming materials are nontoxic and non-sensitizing. Additional testing included corrosion and adaptation accuracy.

Technological Characteristics

Materials: Pure Ti-G4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136), Grade 2 Titanium (ASTM F67-00), Gold Alloy, Cobalt-28 Chromium-6 Molybdenum Alloy (ASTM F799). Features: Universal conical connection, angled (15°-30°) and straight configurations, hex/non-hex options. Sterilization: Autoclave (supplied non-sterile).

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. No specific age or gender restrictions provided.

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

• Implantium (K041368)
• Implantium Abutments (K052823)
• Implantium Prosthetics (K052957)
• SimpleLine II Abutment System (K112045)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12,2014

Dentium Company Limited C/O Ms. Sheryl Higgins US Agent 6761 Katella Avenue Cypress, CA 90630

Re: K141457

Trade/Device Name: Dentium Implantium® and SuperLine® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2014 Received: October 15, 2014

Dear Ms. Higgins:

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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Page 2 - Ms. Higgins

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno, DDS, mA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number: K141457

Dentium Implantium® / SuperLine® Abutments Device Name:

Indications for Use:

Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Prescription Use 区 (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use □ (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

# 1. Company

| | Submitter |
|----------------|-----------------------------------------------------------------------------------------|
| Name | Dentium Co., Ltd. |
| Address | 440, Changnyong-daero, lui-dong, Yeongtong-gu, Suwon-si,<br>Gyeonggi-do, Korea, 443-270 |
| Phone / Fax | [phone] / [phone] |
| Contact person | Sheryl Higgins / US Agent<br>714-226-0229 x107<br>[e-mail] |

## 2. Device Name

| Proprietary name: | Dentium Implantium® / SuperLine® Abutments |
|----------------------|---------------------------------------------------------------|
| Common name: | Abutment, Prosthetic Device |
| Classification name: | Abutment, Implant, Dental, Endosseous<br>NHA, 21 CFR 872.3630 |

#### 3. Predicated Device

k041368 - Dentium Co. Ltd., Implantium k052823 - Implantium Abutments k052957 - Implantium Prosthetics k112045 - SimpleLine II Abutment System

#### 4. Description

Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) k041358. The modified designs proposed in this submission consist of the

COMPANY CONFIDENTIAL

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Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

| Name | Class | Material | Dia<br>(mm) | G/H<br>(mm) | Connection | Angle | Figure | Model Number |
|-----------------------------|-------|---------------------------------------------------------------|------------------|------------------|--------------------|------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Angled<br>Screw<br>Abutment | II | Pure Ti-G4<br>(ASTM F67)<br>TiN Coated | 4.5<br>to<br>5.5 | 1.0<br>to<br>1.5 | Hex and<br>Non-hex | 15°<br>to<br>30° | Image: Angled screw abutment | ASA45151018H<br>ASA45151018N<br>ASA45301018H<br>ASA45301018N<br>ASA55151518H<br>ASA55151518N<br>ASA55301518H<br>ASA55301518N |
| Screw | II | Ti-6Al-4V ELI<br>alloy<br>(ASTM F136) | 1.8<br>to<br>2.3 | n/a | n/a | n/a | Image: Screw | ASASC2023<br>SRS18T |
| Cover<br>Screw | II | Ti-6Al-4V ELI<br>alloy<br>(ASTM F136)<br>Annozided | 3.6 | n/a | n/a | n/a | Image: Cover screw | CS36 |
| Cylinder -<br>Titanium | II | Pure Titanium,<br>Grade 2<br>(ASTM F67-00) | 4.5<br>to<br>5.5 | n/a | Hex and<br>Non-hex | n/a | Image: Titanium cylinder | STC45SG<br>STC45BG<br>STC55SG<br>STC55BG |
| Cylinder -<br>Gold | II | Gold Alloy | 4.5<br>to<br>5.5 | n/a | Hex and<br>Non-hex | n/a | Image: Gold cylinder | SGC45SL<br>SGC45BL<br>SGC55SL<br>SGC55BL |
| Cylinder -<br>Metal | II | Cobalt-28<br>Chromium-6<br>Molybdenum<br>Alloy (ASTM<br>F799) | 4.5<br>to<br>5.5 | n/a | Hex and<br>Non-hex | n/a | Image: Metal cylinder | SGC45CSL<br>SGC45CBL<br>SGC55CSL<br>SGC55CBL |

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#### 5. Indication for Use

Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

## 6. Identification of the Risk

Risk analysis was performed according to ISO 14971:2007, "Medical devices - Application of risk management to medical devices". All risks identified have been mitigated and any residual risk is within acceptable levels.

# 7. Device Characteristics

Dentium Implantium / SuperLine Abutments are supplied in many different shapes and sizes to meet the patient specific needs of our customers. All abutment are made with Dentium's universal conical connection so that thev securely mate with any Dentium Implantium / SuperLine Fixture.

# 8. Performance Testing

Biocompatibility testing on the proposed Implantium & SuperLine Abutments have been completed. Requirements for biological evaluation of the purposed device were based on the ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are nontoxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed:

| -ISO Cytotoxicity | -ISO Systemic toxicity |
|--------------------------------|------------------------|
| -ISO Pyrogenicity | -ISO Sensitization |
| -ISO Intracutaneous reactivity | |

The proposed Implantium & SuperLine Abutments were evaluated using the following performance bench testing to confirm the performance characteristics:

| -ISO Static compressive | -ISO Fatigue |
|-------------------------|----------------------|
| -Corrosion Testing | -Adaptation Accuracy |
| -Modified Surface | |

Static Compressive mean and Fatigue Limit were evaluated per ISO 14801. Fracture or cracks or severe distortion of any parts were not detected at the fatigue limit and passed 5,000,000 cycles.

COMPANY CONFIDENTIAL

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#### 9. Reliance on Standards

All testing was performed in compliance with Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

#### 10. Review

All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Implantium & SuperLine Abutments meet the established specifications necessary for consistent performance according to its intended use.

Implantium & SuperLine Abutments have been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

#### 11. Conclusions

All of the data consistent with the recommendations in the FDA guidance document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments demonstrated that the Dentium Implantium & SuperLine Abutments are substantially equivalent to the predicate device.