3.0 Dynamic TiBase

K162021 · Talladium Espana, SL · NHA · May 4, 2018 · Dental

Device Facts

• Record ID: K162021
• Device Name: 3.0 Dynamic TiBase
• Applicant: Talladium Espana, SL
• Product Code: NHA · Dental
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Story

3.0 Dynamic TiBase is a dental implant abutment used to support multiple tooth prostheses. It functions as an interface between a dental implant and a zirconia superstructure. The device is used in a clinical setting by dental professionals. It features an angulated screw channel, allowing for screw-retained restorations with varying degrees of angulation (0° to 30° depending on the specific implant compatibility). The abutment is manufactured and finalized by Talladium Espana. By providing a stable connection and allowing for angulated access, it facilitates the prosthetic restoration of edentulous spaces, improving functional and aesthetic outcomes for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutment. Materials: Titanium alloy. Features angulated screw channel (0-30 degrees). Connection types: Internal hexagon. Designed for use with zirconia superstructures. Non-sterile, intended for professional use.

Indications for Use

Indicated for partially or fully edentulous patients requiring support for multiple tooth prostheses in the maxilla or mandible.

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.)

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

May 4, 2018

Talladium Espana, SL % Luiz Galdino RA/QA Specialist Luiz Galdino 28102 Alton Way Castaic. California 91384

Re: K162021

Trade/Device Name: 3.0 Dynamic TiBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 4, 2018 Received: April 4, 2018

Dear Luiz Galdino:

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.

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

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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 [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 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number( K162021)

### Device Name

3.0 Dynamic TiBase

#### Indications for Use (Describe)

3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Compatibility of 3.0 Dynamic TiBase®:

| Implant Compatibility | Dynamic TiBase® reference | Trade Name | Implant Diameter (mm) | Abutment Post Height (mm) | Retention Type<br>Single unit = Engaging<br>Multi-Unit = Non-Engaging | Screw Type | Angulation | Abutment Connection |
|-----------------------|---------------------------|-----------------------|-----------------------|---------------------------|-----------------------------------------------------------------------|---------------|------------|---------------------|
| DIO® | IND3OTSHRP/TiA | UF | 4.0 | 4.0 | Multi-unit | Dynamic Screw | 0° to 30° | INTERNAL HEXAGON |
| OSSTEM® | IND3OTSRNP/TiA | TS NARROW<br>PLATFORM | 3.5 | 3.8 | Multi-unit | Dynamic Screw | 0° to 20° | INTERNAL HEXAGON |

All Ti-base abutments, including the designed zirconia superstructure, are intended to be manufactured and finalized by Talladium Espana.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span> <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |

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