510(k) · Cleared
ClearedSpi Titanium Base for Cad/Cam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thommen Medical AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 20, 2011 as substantially equivalent to K083496 (Altatec GmbH, 2009) and 4 other predicates after a 205-day review. Its family tree reaches back 7 generations to 1990. 83 later devices descend from it.
- Decided
- Apr 20, 2011
- Review
- 205 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K894595 (1990). 77 ancestors in all, the oldest K820013 (1982). 83 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- This deviceK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- Descendant · cites it directly · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · cites it directly · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
- Descendant · 2 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
- Descendant · 3 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · cites it directly45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 2 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · cites it directly30descendants
- K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 2 generations on29descendants
- K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| 0 (this device) | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| +1 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +2 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +1 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
| +2 | K122295 | Core 3D Abutment System for Digital Prosthetic Solutions | Core 3D Protech, S.L. | 2013 | — |
| +3 | K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 11 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 8 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (5)
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 |
|---|---|---|---|
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 2…en determined by FDA to be substantially equivalent to pre-amendment devices: Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553; FRIADENT GmnbH, FRIADENT PLUS Dental Implant Syste… | 2009 |
| * | K073553 | Camlog Implant System AbutmentsSummary page 2…es: Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments, cleared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553; FRIADENT GmnbH, FRIADENT PLUS Dental Implant Systems, cleared under K040 170; Implant Innovations, Inc., 3i Patient-Spec… | 2008 |
| * | K040170 | Friadent Plus Dental Implant SystemsSummary page 2…ared under K083496, Altatec GmbH, CAMLOG Implant System Abutments, cleared under K073553; FRIADENT GmnbH, FRIADENT PLUS Dental Implant Systems, cleared under K040 170; Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars, cleared under K032263; and Syb… | 2004 |
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 2…FRIADENT PLUS Dental Implant Systems, cleared under K040 170; Implant Innovations, Inc., 3i Patient-Specific Dental Abutments and Overdenture Bars, cleared under K032263; and Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297. The subject device aind the pred… | 2004 |
| * | K083297 | Pitt-Easy Dental Implant SystemSummary page 2…Patient-Specific Dental Abutments and Overdenture Bars, cleared under K032263; and Sybron Implant Solutions GmbH, Pitt-Easy Dental Implant System, cleared under K083297. The subject device aind the predicate devices are all made of commercially pure titanium or titanium alloy. The subject and pre… | 2009 |
What descends from it? (83)
See all 834 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 77 ancestors have a recall of any class.
- Of its descendants, K103691 (BioHorizons Implant Systems, Inc., 2011) has gone furthest, with 45 descendants of its own.
- 11 other devices also cite its predicate K083496.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Thommen Titanium Base for CAD/CAM abutments are intended to be used in conjunction with Thommen implants and the 3M ESPE LavaTM System in the maxillary and/or mandibular arch to provide support for crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102804: Spi Titanium Base for Cad/Cam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102804
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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