510(k) · Cleared
ClearedIti Synocta Meso Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 20, 2003 as substantially equivalent to K020096 (Institut Straumann AG, 2002) after a 13-day review. Its family tree reaches back 4 generations to 1990. 514 later devices descend from it.
- Decided
- Oct 20, 2003
- Review
- 13 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894844 (1990). 6 ancestors in all. 514 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 2 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 1 generation backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- This deviceK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- Descendant · cites it directly · 434 of its ownK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- Descendant · cites it directly · 328 of its ownK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 2 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- Descendant · 2 generations on · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
Showing 5 of 514 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 514 · See all- K062129P.0004 ImplantsInstitut Straumann AG · 2006 · cites it directly434descendants
- K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · cites it directly328descendants
- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
- K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 2 generations on313descendants
- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · 2 generations on283descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −2 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −1 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| 0 (this device) | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| +1 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| +1 | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +2 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +2 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| +2 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 6 | 0 |
| 2009 | 11 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 24 | 0 |
| 2015 | 26 | 0 |
| 2016 | 31 | 0 |
| 2017 | 28 | 0 |
| 2018 | 26 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 33 | 0 |
| 2022 | 33 | 0 |
| 2023 | 51 | 0 |
| 2024 | 57 | 0 |
| 2025 | 33 | 0 |
| 2026 | 24 | 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 30.7 · 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? (1)
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 |
|---|---|---|---|
| * | K020096 | Esthetic Ease Abutments for the Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Leqally Marketed Devices to which Equivalence is Claimed (Predicate Devices) IT1 Esthetic Abutments (K020096) 4. Description of the Device The IT1 Dental Implant System is an integrated system of endosseous dental… | 2002 |
What descends from it? (514)
See all 5147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062129 | P.0004 Implants | 2006 | 434 |
| K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | 2004 | 328 |
| K052272 | Straumann Computer Aided Restoration Service | 2006 | 268 |
| K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | 2007 | 265 |
| K041275 | Procera Abutment Octagon | 2004 | 61 |
| K122988 | Klockner Dental Implant Abutments | 2013 | 9 |
| K141211 | Inclusive Titanium Abutments Compatible with Straumann Tissue Level Implants | 2014 | 1 |
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 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K062129 (Institut Straumann AG, 2006) has gone furthest, with 434 descendants of its own.
- 1 other device also cites its predicate K020096.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The IT1 synOcta Measo abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033243: Iti Synocta Meso Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033243
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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