510(k) · Cleared
ClearedAngulated Abutment, Complete,Titanium Sdca 102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 27, 1992 after a 632-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 178 later devices descend from it.
- Decided
- Aug 27, 1992
- Review
- 632 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
178 later devices descend from it, 3 citing it directly.
- This deviceK905434 Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc. · 1992
- Descendant · cites it directly · 176 of its ownK962647 Angled AbutmentStraumann USA · 1996
- Descendant · cites it directly · 175 of its ownK994119 Synocta Angled AbutmentsStraumann USA · 2000
- Descendant · 2 generations on · 164 of its ownK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
- Descendant · 3 generations on · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
- Descendant · 4 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- K962647Angled AbutmentStraumann USA · 1996 · cites it directly176descendants
- K994119Synocta Angled AbutmentsStraumann USA · 2000 · cites it directly175descendants
- K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsStraumann Manufacturing, Inc. · 2008 · 2 generations on164descendants
- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · 3 generations on115descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 4 generations on89descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905434 | Angulated Abutment, Complete,Titanium Sdca 102 | Nobelpharma USA, Inc. | 1992 | — |
| +1 | K962647 | Angled Abutment | Straumann USA | 1996 | — |
| +1 | K994119 | Synocta Angled Abutments | Straumann USA | 2000 | — |
| +2 | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004… | Straumann Manufacturing, Inc. | 2008 | — |
| +3 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
| +4 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 17 | 0 |
| 2022 | 16 | 0 |
| 2023 | 20 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (178)
See all 1783 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?
- Of its descendants, K962647 (Straumann USA, 1996) has gone furthest, with 176 descendants of its own.
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 | — |
https://510kreport.com/device/K905434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905434: Angulated Abutment, Complete,Titanium Sdca 102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905434
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026