510(k) · Cleared
ClearedTalladium International Implantology Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium Espana, SL · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 22, 2010 as substantially equivalent to K032263 (Implant Innovations, Inc., 2004) and 9 other predicates after a 526-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jun 22, 2010
- Review
- 526 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 9 generations to K894595 (1990). 75 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK090081 Talladium International Implantology AbutmentsTalladium Espana, SL · 2010
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK090081 Talladium International Implantology AbutmentsTalladium Espana, SL · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −1 | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | 1 |
| 0 (this device) | K090081 | Talladium International Implantology Abutments | Talladium Espana, SL | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 1…Talladium International Implantology Abutments 5 10O(k) Number: K090081 Legally Marketed Predicate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K0… | 2004 |
| * | K925769 | Branemark System Abutments CompleteSummary page 1…alladium International Implantology Abutments 5 10O(k) Number: K090081 Legally Marketed Predicate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439… | 1993 |
| * | K990342 | Synocta ProstheticsSummary page 1…ments 5 10O(k) Number: K090081 Legally Marketed Predicate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K… | 1999 |
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 1…0O(k) Number: K090081 Legally Marketed Predicate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345 De… | 2004 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 1…er: K090081 Legally Marketed Predicate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345 Device Desc… | 2007 |
| * | K020096 | Esthetic Ease Abutments for the Iti Dental Implant SystemSummary page 1…ate Devices External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345 Device Description The Talladium abutments are an artificial… | 2002 |
| * | K060880 | Zimmer Dental One Piece Tapered Abutment, Models TAC1, TACW1, TA5C1Summary page 1…es External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, K072570 Internal Conical abutments, e.g., K020096, K060880, K071439 Internal abutments, e.g., K053355, K073345 Device Description The Talladium abutments are an artificial tooth ab… | 2006 |
| * | K071439 | Zimmer Patient-Specific Abutment, Internal Hex, TitaniumSummary page 1…External Hexagon abutments, e.g., K032263, K925769 Conical abutments, e.g., K990342, K04 1295, 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 de… | 2007 |
| * | K053355 | Bti Interna Dental Implant SystemSummary page 1…3, K925769 Conical abutments, e.g., K990342, K04 1295, 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 e… | 2006 |
| * | K073345 | Certain Contoured Margin Ceramic AbutmentSummary page 1…9 Conical abutments, e.g., K990342, K04 1295, 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… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 75 ancestors have a recall of any class.
- 9 other devices also cite its predicate K032263.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
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…
Read the full statement (178 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090081 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090081: Talladium International Implantology Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090081
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026