510(k) · Cleared
ClearedTBR Idea Conic/Conic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sudimplant SA · DZE Implant, Endosseous, Root-Form
Cleared on Feb 16, 2006 as substantially equivalent to K031475 (Implant Innovations, Inc., 2003) and 3 other predicates after a 307-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it.
- Decided
- Feb 16, 2006
- Review
- 307 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K925765 (1993). 26 ancestors in all, the oldest K874590 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 4 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 3 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 2 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 1 generation backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- This deviceK050956 TBR Idea Conic/ConicSudimplant SA · 2006
- Descendant · cites it directly · 0 of its ownK073622 Easy Grip Dental Implant SystemT.F.I. System S.R.L · 2008
- Descendant · cites it directly · 0 of its ownK070935 T.B.R. ZirconnectSudimplant SA · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −3 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −2 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −1 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| 0 (this device) | K050956 | TBR Idea Conic/Conic | Sudimplant SA | 2006 | — |
| +1 | K073622 | Easy Grip Dental Implant System | T.F.I. System S.R.L | 2008 | — |
| +1 | K070935 | T.B.R. Zirconnect | Sudimplant SA | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1….3640) and Endlosseous dental implant abutment (21 CFR 872.3630) Legally marketed device (predicate devices): *3i Osseotite Certain NT (K031 475) *Bio-Lok Silhouette & Silhouette IC (K032454) *Zimmer Dental (formerly Sulzer Dental) Tapered Screw-Vent (KOl13… | 2003 |
| * | K032454 | Silhouette (TM) IC or Silhouette (TM) & Laser-Lok (TM)Summary page 1…abutment (21 CFR 872.3630) Legally marketed device (predicate devices): *3i Osseotite Certain NT (K031 475) *Bio-Lok Silhouette & Silhouette IC (K032454) *Zimmer Dental (formerly Sulzer Dental) Tapered Screw-Vent (KOl13227,K1(11028) Description of the device: The T.B.R… | 2004 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 2…ic Silhouette Tapered Osseotite Screw-Vent Certain NT 510(k) number K(032454 K013227 1031475 K01 1028 Type Self-Tapping… | 2001 |
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 2…Screw-Vent Certain NT 510(k) number K(032454 K013227 1031475 K01 1028 Type Self-Tapping Self-Tapping Self-Tapping Self-Tapping… | 2001 |
What descends from it? (2)
2 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 13 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K073622 (T.F.I. System S.R.L, 2008) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K031475.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The T.B.R.® ide@ conic endosseous dental implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050956: TBR Idea Conic/Conic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050956
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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