TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS

K090081 · Talladium Espana, SL · NHA · Jun 22, 2010 · Dental

Device Facts

• Record ID: K090081
• Device Name: TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS
• Applicant: Talladium Espana, SL
• Product Code: NHA · Dental
• Decision Date: Jun 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. . the the angulation of the dynamic abutments to 20° off of the long axis of the inplant).

Device Story

Talladium abutments are prosthetic components designed to interface with root-form endosseous dental implants. They serve as the connection point between the implant and the final prosthetic restoration (crowns or bridges). The device line includes various connection geometries: external hexagon, conical, internal conical, and multi-lobed. A dynamic abutment variant allows for angulation correction up to 20° relative to the implant's long axis. Manufactured from tilite (a biocompatible base metal alloy), these abutments are intended for use by dental professionals in clinical settings to restore chewing function in partially edentulous patients. The device is placed into the dental implant, providing the necessary support for the prosthetic reconstruction. Clinical benefit is derived from the restoration of dental function and aesthetics.

Clinical Evidence

No clinical data. Evidence consists of bench testing only. Static and dynamic compression bending tests were performed on four representative dental abutment/implant systems per ISO 14801:2007. All samples passed acceptance criteria. Scanning electron microscopy (SEM) was used to evaluate wear, showing negligible to moderate wear comparable to or less severe than similar studies.

Technological Characteristics

Materials: Tilite (biocompatible base metal alloy). Design: Abutments for external hexagon, conical, internal conical, and multi-lobed implant connections. Dynamic abutment allows 20° angulation correction. Testing: Fatigue testing per ISO 14801:2007. Biocompatibility: Cleared for fixed prosthodontic use.

Indications for Use

Indicated for partially edentulous patients requiring prosthetic restoration of dental implants. Abutments provide support for crowns and bridges. Compatible with various implant interfaces including external hexagon, conical, internal conical, and multi-lobed connections. Dynamic abutment option available for angulation correction up to 20°.

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

• 3i Patient-Specific Dental Abutment and Overdenture Bar (K032263)
• Branemark System Abutments Complete (K925769)
• Synocta Prosthesis (K990342)
• RN Synocta UCLA Gold Abutment for the Straumann Dental Implant (K041295)
• Nobelactive Multiunit Abutment (K072570)
• Esthetic Ease Abutments for the ITI Dental Implant System (K020096)
• Zimmer Dental One Piece Tapered Abutment (K060880)
• TA5C1 (K071439)
• BTI Interna Dental Implant System (K053355)
• Certain Contoured Marigin Ceramic Abutment (K073345)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for Talladium International Implantology. The logo features a stylized globe on the left, followed by the word "Talladium" in a large, bold font. Below "Talladium" are the words "International" and "Implantology" in a smaller font, with "Implantology" underlined.

K090081

### 510(k) Summary

Submitted by: Address:

Esteban Xam-Mar Mangrane Talladium España Av. Madrid 17, alt. 1ª 25002 Lleida (Spain)

JUN 2 2 2010

Telephone:

+34.973289580

Date of Summary:

May 14, 2010

Classification Name: Classification Number: Product Code: Trade Name: 510(k) Number:

Endosseous Dental Implant Abutment 872.3630 NHA Talladium International Implantology Abutments K090081

### Legally Marketed Predicate Devices

External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K041295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345

### Device Description

The Talladium abutments are an artificial tooth abutment designed to fit and function on root-form endosseous implants having various abutment interfaces: an external hexagon. conical, internal conical, and other internal connections such as multi-lobed. Talladium also has a dynamic abutment to correct the angulation of an implant if necessary.

Talladium's abutments are intended for use in the treatment of partially edentulous patients in order to restore chewing function. The Talladium abutments are prosthetic abutments that fit a variety of endosseous implants listed below. Talladium's abutments are made from tilite, a biocompatible Base Metal Alloy material that is used in dental restorations.

### Indication for Use/Intended Use

Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, internal conical, and other internal (e.g., multilobed) implants. A dynamic abutment is available to correct the angulation of an implant if necessary (limiting the angulation of the dynamic abutments to 20° off of the long axis of the implant).

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Image /page/1/Picture/0 description: The image shows the logo for Talladium International Implantology. The logo features a stylized globe on the left, followed by the word "Talladium" in a large, bold font. Below "Talladium" are the words "International" and "Implantology" in a smaller font, with "Implantology" underlined.

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The Talladium abutments have been tested with the following implant systems:

- · Group 1, External Hexagon Abutments: 3i Implant Innovations, Biomet
- · Group 2, Conical Abutments: Nobel Biocare Multi-Unit
- Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD .
- · Group 4, Internal Abutments: Nobel Biocare Replace RP

Talladium abutments are compatible with the following implants: 31 Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.

### Performance Standards

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was followed as applicable to this submission. Performance (fatigue) testing according to ISO 14801:2007' has ensured the appropriate design of the Talladium devices.

### Non-Clinical Performance Data

Static and dynamic tests of compression bending were performed for four dental abutment and implant systems, one (the most susceptible) for each type of connection, according to ISO 14801:2007, including the dynamic abutment. All testing passed the acceptance criteria. In addition, scanning electron microscopy (SEM) was performed to examine particle formation of tested pieces. In all cases, SEM testing showed negligible to moderate wear, and wear was comparable or less severe than in similar studies.

The Talladium abutments are composed of tilite with titanium allov. Biocompatibility of this biomaterial has previously been cleared by FDA for use in fixed prosthodontic devices with tissue contact similar to that of the Talladium abutments.

### Basis for Substantial Equivalence

The Talladium Abutments are substantially equivalent in terms of intended use, design, and performance to the predicate devices (see next page). The exact configuration of currently marketed abutments is duplicated in the Talladium abutment series, and nonclinical performance testing (fatigue testing and biocompatibility) was used to validate that performance was acceptable for intended use. Taken together, these factors support the substantial equivalence of Talladium abutments to the predicate devices.

^{1 180 14801:2007.} Dentistry - Implants - Dynamic Fatigue Testing for Endosseus Dental Implants.

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# SUBSTANTIAL EQUIVALENCE TABLE

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| CATEGORY, 510(k) NUMBER | TRADE NAME, MANUFACTURER | DESCRIPTION | SIMILARITIES | DIFFERENCES | SIGNIFICANCE OF DIFFERENCE |
|-------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| External Hexagon<br>K032263 | 3i Patient-Specific<br>Dental Abutment and<br>Overdenture Bar,<br>Implant Innovations Inc.<br>DZE | Series of dental<br>abutments and<br>overdenture bars | Talladium 3i-type<br>abutments are the same<br>shape, design and use as<br>K032263 | No overdenture bars in<br>current 510(k), material<br>not known | None |
| External Hexagon<br>K925769 | Branemark System<br>Abutments Complete,<br>Nobelpharma<br>DZE | Series of abutments | Talladium Branemark-<br>type abutments are the<br>same shape, design and<br>use as K925769 | Material not known | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Conical<br>K990342 | Synocta Prosthesis,<br>Straumann<br>DZE | Series of abutments, and<br>other components | Titanium alloy and<br>other materials | Some materials<br>different | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Conical<br>K041295 | RN Synocta UCLA<br>Gold Abutment for the<br>Straumann Dental<br>Implant, Institut<br>Straumann AG<br>NHA | Series of abutments | Talladium Strauman-<br>type abutments are the<br>same shape, design and<br>use as K041295 | Material not reported | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Conical<br>K072570 | Nobelactive Multiunit<br>Abutment, Nobel<br>Biocare AB<br>NHA | Abutment | Talladium Nobel<br>Biocare-type abutments<br>are the same shape,<br>design and use as<br>K072570 | Material not known | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Internal Conical<br>K020096 | Esthetic Ease<br>Abutments for the ITI<br>Dental Implant System,<br>Institut Straumann AG<br>DZE | System of implants,<br>abutments, surgical<br>parts, and instruments<br>Material: Titanium | Talladium Strauman-<br>type abutments are the<br>same shape, design and<br>use as K020096 | Different material; no<br>implants in current<br>510(k) | Acceptable change<br>because material<br>successfully tested for<br>biocompatibility, fatigue<br>and particle formation |
| Internal Conical<br>K060880 | Zimmer Dental One<br>Piece Tapered<br>Abutment, Models | Zimmer tapered<br>abutments | Talladium Zimmer-type<br>abutments are the same<br>shape, design and use as | None | None |
| CATEGORY, 510(k)<br>NUMBER | TRADE NAME,<br>MANUFACTURER | DESCRIPTION | SIMILARITIES | DIFFERENCES | SIGNIFICANCE OF<br>DIFFERENCE |
| Internal Conical<br>K071439 | TA5C1, Zimmer Dental<br>Inc. | Zimmer Patient-Specific<br>Abutment, Internal Hex,<br>Titanium, Zimmer<br>Dental Inc. | Titanium alloy, called<br>"patient-specific" | None known | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Internal Abutments<br>K053355 | DZE<br>BTI Interna Dental<br>Implant System, BTI<br>Biotechnology Institute,<br>SL | System of implants and<br>abutments | Talladium BTI-type<br>abutments are the same<br>shape, design and use as<br>K053355 | Material not reported,<br>no implants in current<br>510(k) | Talladium material and<br>fatigue testing shows<br>acceptable performance |
| Internal Abutments<br>K073345 | DZE<br>Certain Contoured<br>Marigin Ceramic<br>Abutment, Biomet 3i<br>NHA | System of Biomet 3i<br>Certain abutments | Talladium Biomet 3i-<br>type abutments are the<br>same shape, design and<br>use as K073345 | Different material<br>(ceramic) | Acceptable change -<br>because material<br>successfully tested for<br>biocompatibility, fatigue<br>and particle formation |

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Image /page/3/Picture/0 description: The image shows the word "Talladium" in a large, bold, sans-serif font. Below the word "Talladium" is the text "International Implantology" in a smaller font. Below the text is a circular logo that is partially obscured.

ਦੂ ਹੈ। ਇਹ ਸਾਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਹ ਸਾਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ । ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕੀਤੀ ਹੈ। ਇਸ ਦੀ ਇੱਕ ਸਿੰਘ ਦੇ ਸੰਗਲ ਦੀ ਸਾਹਿਤ ਕ

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

Talladium Europe S.L. C/O Ms. Diane Horwitz Mandell Horwitz Consulting LLC 2995 Steven Martin Drive Fairfax, Virginia 22031

## JUN 2 2 2010

Re: K090081

Trade/Device Name: Talladium International Implantology Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 11, 2010 Received: June 16, 2010

Dear Ms. Horwitz:

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. Horwitz

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

The Arts of the Children WDAY

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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K090081

# Indications for Use

510(k) Number (if known): K090081

Device Name: Talladium International Implantology Abutments

Indications For Use:

Talladium abutments are used in connection with the prosthetic restoration of dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. The Talladium abutments fit implants with external hexagon, conical, conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implants. .
the the angulation of the dynamic abutments to 20° off of the long axis of the inplant).

The Talladium abutments have been tested with the following implant systems:

- Group 1, External Hexagon Abutments: 31 Implant Innovations, Biomet .
- . Group 2, Conical Abutments: Nobel Biocare Multi-Unit
- . Group 3, Internal Conical Abutments: Zimmer Screw-Vent SD
- Group 4, Internal Abutments: Nobel Biocare Replace RP .

Talladium abutments are compatible with the following implants:

3 i Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Klockner external hexagon implants; Straumann and Nobel Biocare conical implants; Inc., Inc., Inc., Zimmer, BioHorizons and Blue Sky Bio internal hexagonal implants; and Nobel Biocare and Blue Sky Bio Trilobe platform internal connections.

Prescription Use X (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 IF NEEDED)

Suasan Sunor

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090081

Concurrence of CDRH, Office of Device Evaluation (ODE)