Dentium NR Line CAD/CAM Abutments

K170384 · Dentium Co., Ltd. · NHA · Aug 17, 2017 · Dental

Device Facts

• Record ID: K170384
• Device Name: Dentium NR Line CAD/CAM Abutments
• Applicant: Dentium Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation. All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Device Story

Dentium NR Line CAD/CAM Abutments are patient-specific dental abutments used for prosthetic rehabilitation. The workflow involves digital design of the abutment, followed by transmission of the design data to a Dentium-validated milling center for fabrication. The final abutment is attached to an endosseous dental implant to support a dental prosthesis. The device is intended for use by dental professionals in a clinical setting. The system facilitates customized prosthetic solutions for patients requiring tooth replacement.

Clinical Evidence

Bench testing only.

Technological Characteristics

CAD/CAM manufactured dental abutments. Materials are consistent with standard dental implant abutment materials (e.g., titanium or zirconia). Designed via CAD software and fabricated at a validated milling center. Class II device.

Indications for Use

Indicated for patients with edentulous or partially edentulous maxilla or mandible requiring prosthetic rehabilitation via endosseous dental implants.

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

• Dentium CAD/CAM Abutments (K152656)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 17, 2017

Dentium Co., Ltd. Sangpil Yoon Regulatory Affairs Specialist 150. Eondong-ro. Giheung-gu Yongin-si, 16985 SOUTH KOREA

Re: K170384

Trade/Device Name: Dentium NR Line CAD/CAM Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 21, 2017 Received: July 25, 2017

Dear Sangpil Yoon:

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K170384

#### Device Name

Dentium NR Line CAD/CAM Abutments

#### Indications for Use (Describe)

Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> 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 [e-mail]

"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."