# K090081: Talladium International Implantology Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Talladium Espana, SL
- Decided: Jun 22, 2010 after 526 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar, Implant Innovations, Inc. (2004) Summary page 1.
- K925769: Branemark System Abutments Complete, Nobelpharma USA, Inc. (1993) Summary page 1.
- K990342: Synocta Prosthetics, Straumann USA (1999) Summary page 1.
- K041295: RN Synocta Ucla Gold Abutment for the Straumann Dental Implant, Institut Straumann AG (2004) Summary page 1.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 1.
- K020096: Esthetic Ease Abutments for the Iti Dental Implant System, Institut Straumann AG (2002) Summary page 1.
- K060880: Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1, Zimmer Dental, Inc. (2006) Summary page 1.
- K071439: Zimmer Patient-Specific Abutment, Internal Hex, Titanium, Zimmer Dental, Inc. (2007) Summary page 1.
- K053355: Bti Interna Dental Implant System, B.T.I. Biotechnology Institute, Sl. (2006) Summary page 1.
- K073345: Certain Contoured Margin Ceramic Abutment, Biomet 3i, Inc. (2008) Summary page 1.

## 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, internal conical, and other internal (e.g., multi-lobed) implants. A dynamic abutment is available to correct the angulation of an implant if necessary (limiting the angulation of the dynamic abutments to 200 off of the long axis of the implant). The Talladium abutments have been tested with the following implant systems: * Group I, 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 RIP Talladium abutments are compatible with the following implants: 3i Implant Innovations Biomet, Innova, Life-Core, Nobel Biocare, Implamed, Zimmer, IMZ, Bti, Kiockner external hexagon implants; Straumann and Nobel Biocare conical implants; Zimmer, BioHorizons and Blue Sky Rio internal hexagonal implants; and Nobel Biocare and Blue Sky Bjo Trilobe platform internal connections.

Source page: https://510kreport.com/device/K090081
Methodology: https://510kreport.com/methodology