510(k) · Cleared
ClearedSynocta Prosthetics
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 Jul 20, 1999 as substantially equivalent to K894844 (Straumann Institute, Ltd., 1990) and 1 other predicate after a 166-day review. Its family tree reaches back 1 generation to 1990. 696 later devices descend from it.
- Decided
- Jul 20, 1999
- Review
- 166 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894844 (1990). 2 ancestors in all. 696 later devices descend from it, 14 citing it directly.
- Root · 1 generation backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- This deviceK990342 Synocta ProstheticsStraumann USA · 1999
- Descendant · cites it directly · 575 of its ownK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- Descendant · cites it directly · 535 of its ownK012757 Iti Dental Implant SystemStraumann USA · 2001
- Descendant · cites it directly · 520 of its ownK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- Descendant · cites it directly · 516 of its ownK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- Descendant · 2 generations on · 514 of its ownK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
Showing 5 of 696 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 696 · See all- K013798Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001 · cites it directly575descendants
- K012757Iti Dental Implant SystemStraumann USA · 2001 · cites it directly535descendants
- K022859Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002 · cites it directly520descendants
- K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · cites it directly516descendants
- K033243Iti Synocta Meso AbutmentsStraumann USA · 2003 · 2 generations on514descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| 0 (this device) | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| +1 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| +1 | K012757 | Iti Dental Implant System | Straumann USA | 2001 | — |
| +1 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| +1 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| +2 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 11 | 0 |
| 2007 | 18 | 0 |
| 2008 | 13 | 0 |
| 2009 | 12 | 0 |
| 2010 | 16 | 0 |
| 2011 | 18 | 0 |
| 2012 | 23 | 0 |
| 2013 | 26 | 0 |
| 2014 | 34 | 0 |
| 2015 | 39 | 0 |
| 2016 | 37 | 0 |
| 2017 | 35 | 0 |
| 2018 | 34 | 0 |
| 2019 | 30 | 0 |
| 2020 | 50 | 0 |
| 2021 | 43 | 0 |
| 2022 | 43 | 0 |
| 2023 | 58 | 0 |
| 2024 | 64 | 0 |
| 2025 | 47 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…Dental Implant (21 CFR 872.3640) 3. [ eqally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Abutments, copings, transfer system components (K894844 and K943720) Nobel Biocare’s prosthetic accessories Implant Innovations’ prosthetic accessories Friatec’s prosthetic accessori… | 1990 |
| * | K943720 | Iti Transversal Screwing SystemSummary page 1…ant (21 CFR 872.3640) 3. [ eqally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Abutments, copings, transfer system components (K894844 and K943720) Nobel Biocare’s prosthetic accessories Implant Innovations’ prosthetic accessories Friatec’s prosthetic accessories 4. Descr… | 1995 |
| * | — | Nobel Biocare’s prosthetic accessories Named without a submission number | |
| * | — | Implant Innovations’ prosthetic accessories Named without a submission number | |
| * | — | Friatec’s prosthetic accessories Named without a submission number |
What descends from it? (696)
See all 69614 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013798 | Prosthetic Accessories to the Iti Dental Implant System | 2001 | 575 |
| K012757 | Iti Dental Implant System | 2001 | 535 |
| K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | 2002 | 520 |
| K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | 2002 | 516 |
| K051717 | RN Synocta Temporary Meso Abutment | 2005 | 318 |
| K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | 2007 | 265 |
| K994119 | Synocta Angled Abutments | 2000 | 175 |
| K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings | 2008 | 164 |
| K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw | 2014 | 115 |
| K111935 | TI-Base Abutment, 1 Connect Abutment | 2012 | 64 |
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?
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?
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and cylinders, and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the…
Read the full statement (122 words)
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and cylinders, and transfer system components.
Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.
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/K990342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990342: Synocta Prosthetics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990342
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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