510(k) · Cleared
ClearedSynocta Angled Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Mar 17, 2000 as substantially equivalent to K990342 (Straumann USA, 1999) and 2 other predicates after a 102-day review. Its family tree reaches back 2 generations to 1992. 175 later devices descend from it.
- Decided
- Mar 17, 2000
- Review
- 102 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K905434 (1992). 6 ancestors in all, the oldest K894844 (1990). 175 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK905434 Angulated Abutment, Complete,Titanium Sdca 102Nobelpharma USA, Inc. · 1992
- 1 generation backK962647 Angled AbutmentStraumann USA · 1996
- This deviceK994119 Synocta Angled AbutmentsStraumann USA · 2000
- Descendant · cites it directly · 164 of its ownK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
- Descendant · 2 generations on · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 64 of its ownK111935 TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsStraumann Manufacturing, Inc. · 2008 · cites it directly164descendants
- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · 2 generations on115descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
- K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012 · 2 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905434 | Angulated Abutment, Complete,Titanium Sdca 102 | Nobelpharma USA, Inc. | 1992 | — |
| −1 | K962647 | Angled Abutment | Straumann USA | 1996 | — |
| 0 (this device) | K994119 | Synocta Angled Abutments | Straumann USA | 2000 | — |
| +1 | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004… | Straumann Manufacturing, Inc. | 2008 | — |
| +2 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K111935 | TI-Base Abutment, 1 Connect Abutment | Nt-Trading GmbH and CO KG | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 | 10 | 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), 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? (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 |
|---|---|---|---|
| * | K990342 | Synocta ProstheticsSummary page 1…on Name: Accessories to Endosseous Dental Implant (21 CFR 872.3640) Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI® synOcta® Abutment (K990342) ITI® Angled Abutment (K962647) Calcitek Angled Abutment (K number unknown) Nobel Biocare Angled Abutment (K905434) Implant I… | 1999 |
| * | K962647 | Angled AbutmentSummary page 1…us Dental Implant (21 CFR 872.3640) Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI® synOcta® Abutment (K990342) ITI® Angled Abutment (K962647) Calcitek Angled Abutment (K number unknown) Nobel Biocare Angled Abutment (K905434) Implant Innovations Angled Abutment (K nu… | 1996 |
| * | K905434 | Angulated Abutment, Complete,Titanium Sdca 102Summary page 1…Claimed (Predicate Devices) ITI® synOcta® Abutment (K990342) ITI® Angled Abutment (K962647) Calcitek Angled Abutment (K number unknown) Nobel Biocare Angled Abutment (K905434) Implant Innovations Angled Abutment (K number unknown) Description of the Device The subject device of this 510(k) is the ITI®… | 1992 |
| * | — | Calcitek Angled Abutment Named without a submission number | |
| * | — | Implant Innovations Angled Abutment Named without a submission number |
What descends from it? (175)
See all 1755 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings | 2008 | 164 |
| K172668 | W Zirconia Implants | 2018 | 4 |
| K013891 | Synocta Angled Abutments for the Iti Wide Neck Implant | 2002 | 2 |
| K070533 | Bti Endosseous Dental Implant Angled Abutments | 2007 | 0 |
| K040205 | Intra-Lock International Angled Prosthetic Abutments | 2004 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K080239 (Straumann Manufacturing, Inc., 2008) has gone furthest, with 164 descendants of its own.
- 13 other devices also cite its predicate K990342.
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 synOcta® angled abutments are indicated for use in cases where the placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations.
The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.
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/K994119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994119: Synocta Angled Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994119
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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