TI-BASE ABUTMENT, 1 CONNECT ABUTMENT

K111935 · Nt-Trading GmbH and CO KG · NHA · Feb 17, 2012 · Dental

Device Facts

• Record ID: K111935
• Device Name: TI-BASE ABUTMENT, 1 CONNECT ABUTMENT
• Applicant: Nt-Trading GmbH and CO KG
• Product Code: NHA · Dental
• Decision Date: Feb 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation.

Device Story

Ti-Base and 2-CONnect are premanufactured dental abutments; function as prosthetic interfaces between endosseous dental implants and final restorations. Ti-Base supports single/multiple tooth cement-retained prostheses; 2-CONnect supports bridges and bars. Compatible with various commercial dental CAD/CAM systems (e.g., 3Shape, Exocad, Dental Wings) for custom milling of zirconium components. Operated by dental professionals in clinical settings. Device provides structural support for prosthetic rehabilitation; improves functional and aesthetic outcomes for edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing performed according to ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous implants) to demonstrate compatibility with intended implant systems.

Technological Characteristics

Materials: Ti-6Al-4V titanium alloy. Components: Abutment and screw (Ti-Base); Abutment, screw, and titanium cap (2-CONnect). Connectivity: Compatible with third-party dental CAD/CAM systems. Sterilization: Not specified. Form factor: Custom-milled zirconium-compatible abutments.

Indications for Use

Indicated for partially or completely edentulous patients requiring prosthetic restoration support. Ti-Base abutments support single and multiple tooth prostheses (cement-retained) in the mandible or maxilla. 2-CONnect abutments support bars and bridges in multiple tooth restorations. Compatible with specific Nobel Biocare, Biomet 3i, Straumann, Zimmer, Astra Tech, and Dentsply-Friadent implant systems.

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

• Sirona Dental Systems Sirona Dental CAD/CAM System (K100152)
• Atlantis™ Straumann Bone Level Abutment (K083871)
• Atlantis™ Abutment for Nobel Active Implant (K093483)
• Biomet 3I Dental Abutments And Restorative Components (K072642)
• synOcta® Prosthetics (K990342)
• P.004 Abutments (K080239)
• NobelActive™ Multi Unit Abutment (K072570)

Submission Summary (Full Text)

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| | 510(k) Summary | K111935 | FEB 17 2012 | |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|--|
| Submitter Name:<br>Submitter Address: | NT-Trading GmbH & Co. KG<br>Essostrasse 16<br>76187 Karlsruhe<br>Germany | | | |
| Phone Number:<br>Fax Number: | [phone]<br>[phone] | | | |
| Contact Person: | Dirk Jahn | | | |
| Date Prepared: | June 29, 2011 | | | |
| Device Trade Name: | Ti-Base Abutment<br>2-CONnect Abutment | | | |
| Common Name: | Dental Abutments | | | |
| Classification Name,<br>Number &<br>Product Code: | Abutment, Implant, Dental, Endosseous<br>872.3630<br>NHA | | | |
| Predicate Devices: | (K100152) Sirona Dental Systems Sirona Dental CAD/CAM System, (K083871)<br>Atlantis™ Straumann Bone Level Abutment, (K093483) Atlantis™ Abutment for<br>Nobel Active Implant, (K072642) Biomet 3I Dental Abutments And Restorative<br>Components, (K990342) synOcta® Prosthetics, (K080239) P.004 Abutments,<br>(K072570) NobelActive™ Multi Unit Abutment | | | |
| Device Description and<br>Statement of Intended Use | The Ti-Base Abutment is a premanufactured prosthetic component supplied in two<br>parts, the abutment and screw, for fixation onto dedicated endosseous dental<br>implants and is intended for use as an aid in prosthetic rehabilitation. | | | |
| | The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment<br>to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment<br>screw). The cap on top fits exactly to the abutment-geometry and does not have a<br>rotation fixation, so it is easier to work with (not indicated for single crowns but strictly<br>for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation. | | | |
| | The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available<br>dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems<br>must be validated by the user. | | | |
| | Indication for use:<br>Ti-Base Abutments: The devices covered by this submission are abutments which<br>are placed into a dental implant to provide support for a prosthetic restoration. | | | |
| | The Ti-Base abutments are intended for use to support a prosthetic device in a<br>partially or completely edentulous patient. It is intended for use to support single and<br>multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement<br>retained to the abutment. The abutment screw is intended to secure the abutment to<br>the endosseous implant. | | | |
| | The Ti-Base abutments are indicated for use with the following implant systems: | | | |

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| | Nobel Biocare® Replace Select® Nobel Biocare NobelActive™ Biomet 3i® Osseotite® Biomet 3i® Osseotite® Certain® Nobel Biocare Branemark® Straumann® synOcta® Straumann® Bone Level® Zimmer® Tapered Screw-vent® Astra Tech OsseoSpeed® Dentsply-Friadent® Frialit® |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2-CONnect Abutments: 2-CONnect abutment is indicated for use to provide support<br>for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can<br>be used in multiple tooth restorations. The 2-CONnect abutment can be used<br>together with cemented bridges and bar constructions for functional and aesthetical<br>reconstruction.<br>The 2-CONnect abutments are indicated for use with the following implant systems: Nobel Biocare® Replace Select® Straumann® synOcta® Straumann® BoneLevel® |
| Summary of Technological<br>Characteristics | The proposed Ti-Base abutments and 2-CONnect abutments are substantially<br>equivalent to the currently cleared devices. They are substantially equivalent in<br>intended use, material and connection interfaces to the implants are identical for each<br>individual diameter and connection type. Comparison Demonstrating Substantial<br>Equivalence follows at the end of this section.<br><br>Testing Summary |
| | In order to demonstrate compatibility of Ti-Base and 2-CONnect abutments to each<br>implant system, fatigue testing was performed according to ISO 14801 Dentistry-<br>Implants-Dynamic fatigue test for endosseous implants. Testing was performed on<br>the abutments in this submission with the implants that they are intended to fit. See<br>section 18. |
| Conclusion | The information discussed above demonstrates that the NT-Trading Ti-Base Dental<br>Abutments and 2-CONnect Abutments are substantially equivalent to the predicate<br>devices. |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information. |

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Submitter:
NT-Trading GmbH & Co. KG

## Summary of Technical Characteristics

| Feature | 510(k) Number | Manufacturer | Classification #<br>& Product Code | Intended Use | | | | | | | | | | | | | |
|-------------------------------------------------------------------|---------------|-------------------------------------|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Ti-Base and 2-CONnect | K100152 | Nt-Trading GmbH<br>& Co. KG | 872.3630<br>NHA | Ti-Base<br>Abutments: The<br>devices covered by<br>this submission are<br>abutments which<br>are placed into a<br>dental implant to<br>provide support for<br>a prosthetic<br>restoration.<br><br>The Ti-Base<br>abutments are<br>intended for use to<br>support a<br>prosthetic device in<br>a partially or<br>completely<br>edentulous patient.<br>It is intended for<br>use to support<br>single and multiple<br>tooth prosthesis, in<br>the mandible or<br>maxilla. The<br>prosthesis can be<br>cement retained to<br>the abutment. The | | | | | | | | | | | | | |
| Sirona Dental<br>Systems Sirona<br>Dental CAD/CAM<br>System | K083871 | Sirona Dental<br>Systems GmbH | 872.3630<br>NHA | The Sirona Dental<br>CAD/CAM System<br>is intended for use<br>in partially or fully<br>edentulous<br>mandibles and<br>maxillae in support<br>of single or<br>multiple-unit<br>cement retained<br>restorations.<br><br>The system<br>consists of three<br>major parts:<br>TiBase, InCoris<br>mesostructure, and<br>CAD/CAM<br>software.<br><br>Specifically, the<br>InCoris<br>mesostructure and<br>TiBase<br>components make<br>up a two-piece<br>abutment which is<br>used in conjunction<br>with endosseous<br>dental implants to<br>restore the function | | | | | | | | | | | | | |
| Atlantis ™<br>Straumann<br>Bone Level<br>Abutment | K083871 | Astra Tech Inc. | 872.3630<br>NHA | The devices<br>covered by this<br>submission are<br>abutments which<br>are placed into a<br>dental implant to<br>provide support<br>for a prosthetic<br>reconstruction.<br><br>The Atlantis<br>Abutment is<br>intended for use<br>with an<br>endosseous<br>implant to<br>support a<br>prosthetic device<br>in a partially or<br>completely<br>edentulous<br>patient. It is<br>intended for use<br>to support single<br>and multiple<br>tooth prosthesis,<br>in the mandible<br>or maxilla. The<br>prosthesis can | | | | | | | | | | | | | |
| Atlantis ™™<br>Abutment for<br>Nobel Active<br>Implant | K093483 | Astra Tech Inc. | 872.3630<br>NHA | The Atlantis<br>Abutment is<br>intended for use<br>with an<br>endosseous<br>implant to<br>support a<br>prosthetic device<br>in a partially or<br>completely<br>edentulous<br>patient. It is<br>intended for use<br>to support single<br>and multiple<br>tooth prosthesis,<br>in the mandible<br>or maxilla. The<br>prosthesis can<br>be cement<br>retained to the<br>abutment. The<br>abutment screw<br>is intended to<br>secure the<br>abutment to the<br>endosseous<br>implant. | | | | | | | | | | | | | |
| Biomet 3i<br>Dental<br>Abutments And<br>Restorative<br>Components | K072642 | Biomet 3i, Inc. | 872.3630<br>NHA | BIOMET 3i<br>Dental<br>Abutments and<br>Overdenture<br>Bars are<br>intended for use<br>as an accessory<br>to endosseous<br>dental implants<br>to support a<br>prosthetic device<br>in a partially or<br>edentulous<br>patient. These<br>are intended for<br>use to support<br>single and<br>multiple tooth<br>prostheses, in<br>the mandible or<br>maxilla. The<br>prostheses<br>can be screw or<br>cement retained<br>to the abutment. | | | | | | | | | | | | | |
| synOcta®<br>Prosthetics | K990342 | Straumann®<br>USA | 872.3630<br>NHA | ITI Dental<br>implants are<br>intended to be<br>placed in the<br>maxillary and/or<br>mandibular<br>arch to support<br>crowns, bridges<br>or overdentures<br>in edentulous<br>or partially<br>edentulous<br>patients. The<br>prosthetic<br>accessories to<br>dental implants<br>are used either<br>in the process<br>of fabricating<br>the prosthetic<br>restoration for<br>the implant or<br>as part of the<br>prosthetic<br>restoration. | | | | | | | | | | | | | |
| P.004<br>Abutments | K080239 | Straumann®<br>Manufacturing,<br>Inc | 872.3630<br>NHA | Abutments are<br>placed into<br>dental implants<br>to provide<br>support for<br>prosthetic<br>restorations<br>such as<br>crowns,<br>bridges and<br>overdentures.<br>Abutments can<br>be used in<br>single tooth<br>replacements<br>and multiple<br>tooth<br>restorations.<br>The subject<br>abutments are<br>for permanent<br>screw-retained<br>bridges and<br>bar-retained<br>implant-borne<br>dentures.<br>Permanent<br>copings are<br>intended to | | | | | | | | | | | | | |
| Nobel Active™<br>Multi Unit<br>Abutment | K072570 | Nobel Biocare®<br>AB | 872.3630<br>NHA | Nobel Biocare's<br>Multi-Unit is a<br>premanufactured<br>prosthetic<br>component<br>directly<br>connected to<br>endosseous<br>dental implants<br>and is<br>intended for use<br>as an aid in<br>prosthetic<br>rehabilitation. | | | | | | | | | | | | | |

Section 5.0: 510(k) Summary

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Submitter:
NT-Trading GmbH & Co. KG

Section 5.0: 510(k) Summary

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Submitter:
NT-Trading GmbH & Co. KG

Dental Abutments
Premarket Notification: Traditional 510(k)

| used in multiple<br>tooth restorations.<br>The 2-CONnect<br>abutment can be<br>used together with<br>cemented bridges<br>and bar<br>constructions for<br>functional and<br>aesthetical<br>reconstruction.<br>The 2-CONnect<br>abutments are<br>indicated for use<br>with the following<br>implant systems:<br>• Nobel Biocare®<br>• Replace Select®<br>• Straumann®<br>synOcta®<br>• Straumann®<br>BoneLevel® | Same | Same | Same | Same | Same | Same | Same | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|----------------|-----------------------------|----------------|
| Abutment<br>Diameter min.<br>Diameter max.<br>Abutment Height | 3.5 mm<br>6.5 mm<br>Ti-Base: 4 mm<br>2-CONnect: 2.3 / 4.3 mm | Same | Same | 4/ 5.5 mm | 6.6 mm | 7.0 | 1.5 / 6.0 | 1.5 / 6.0 | 1.0 / 5.5 mm |
| Mode of Action | Screw-retained or<br>cement retained | Screw-retained or<br>cement retained | Screw-retained<br>or cement<br>retained | Screw-retained<br>or cement<br>retained | Screw-retained<br>or cement<br>retained | Screw-retained<br>or cement<br>retained | Screw retained | Screw retained | Screw retained |
| Reusable | No | No | No | No | No | No | No | No | No |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6A1- 4V ELI | Ti-6Al-4V | Ti-6Al-4V | Titanium,<br>Titanium alloy | Titanium Alloy |

For the reasons stated above, we believe a determination of substantial equivalence between the Ti-Base and 2-CONnect and these predicate
devices is appropriate.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

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

NT-Trading GmbH & Company AG C/O Mr. William Greenrose President Oserve America, Inc. 220 River Road Claremont, New Hampshire 03743

FEB 1 7 2012

Re: K111935

Trade/Device Name: Ti-Base for Individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges and Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 28, 2011 Received: February 14, 2012

Dear Mr. Greenrose:

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 – Mr. Greenrose

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. or the Fet of all, I outh 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 (reporting of medical as not to 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), n you desire specific as for JAboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1580 htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Thiso, preace now as a 807.97). For questions regarding the reporting of premainer wonter the MDR regulation (21 CFR Part 803), please go to auverse events under the NDR rogalasate('/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 Touring 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh foc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): | K111935 |
|---------------------------|---------|
|---------------------------|---------|

Ti-Base for individual milled Zirconium Abutment, 2-CONnect Abutment for Bridges Device Name: and Bars

Indications For Use:

Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.

The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Ti-Base abutments are indicated for use with the following implant systems:

- Nobel Biocare® Replace Select® .
- Nobel Biocare NobelActive TM .
- Biomet 3i® Osseotite® .
- Biomet 3i® Osseotite® Certain® .
- Nobel Biocare Branemark® ●
- Straumann® synOcta® .
- Straumann® Bone Level® .
- Zimmer® Tapered Screw-vent® .
- Astra Tech OsseoSpeed® .
- Dentsply-Friadent® Frialit® .

2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:

- Nobel Biocare® Replace Select® .
- Straumann® synOcta® .
- Straumann® BoneLevel® .

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: