510(k) · Cleared
ClearedProsthetic Accessories to the Iti Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Dec 19, 2001 as substantially equivalent to K990342 (Straumann USA, 1999) and 2 other predicates after a 34-day review. Its family tree reaches back 2 generations to 1990. 575 later devices descend from it.
- Decided
- Dec 19, 2001
- Review
- 34 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894844 (1990). 4 ancestors in all. 575 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 1 generation backK990342 Synocta ProstheticsStraumann USA · 1999
- This deviceK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 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
- Descendant · 3 generations on · 434 of its ownK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- Descendant · 3 generations on · 328 of its ownK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · 4 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
Showing 5 of 575 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 575 · See all- K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · cites it directly516descendants
- K033243Iti Synocta Meso AbutmentsStraumann USA · 2003 · 2 generations on514descendants
- K062129P.0004 ImplantsInstitut Straumann AG · 2006 · 3 generations on434descendants
- K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 3 generations on328descendants
- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 4 generations on327descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −1 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| 0 (this device) | 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 |
| +2 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| +3 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| +3 | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +4 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 14 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 10 | 0 |
| 2011 | 12 | 0 |
| 2012 | 17 | 0 |
| 2013 | 20 | 0 |
| 2014 | 29 | 0 |
| 2015 | 30 | 0 |
| 2016 | 31 | 0 |
| 2017 | 32 | 0 |
| 2018 | 31 | 0 |
| 2019 | 27 | 0 |
| 2020 | 45 | 0 |
| 2021 | 37 | 0 |
| 2022 | 38 | 0 |
| 2023 | 53 | 0 |
| 2024 | 58 | 0 |
| 2025 | 35 | 0 |
| 2026 | 25 | 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? (3)
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…s Classification Name: Endosseous dental implants 21 CFR 872.3640 Leqgally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI synOcta Abutment (K990342) [Tl Temporary Posts (K990342) ITI Plastic Copings (K990342) ITI Healing Cap (K003271) ITI Closure Screw (K894844) Description… | 1999 |
| * | K003271 | Modification to Iti Dental Implant SystemSummary page 1…Devices to which Equivalence is Claimed (Predicate Devices) ITI synOcta Abutment (K990342) [Tl Temporary Posts (K990342) ITI Plastic Copings (K990342) ITI Healing Cap (K003271) ITI Closure Screw (K894844) Description of the Device The ITI Dental Implant System is an integrated system of endosseous den… | 2001 |
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…is Claimed (Predicate Devices) ITI synOcta Abutment (K990342) [Tl Temporary Posts (K990342) ITI Plastic Copings (K990342) ITI Healing Cap (K003271) ITI Closure Screw (K894844) Description of the Device The ITI Dental Implant System is an integrated system of endosseous dental implants which are design… | 1990 |
What descends from it? (575)
See all 5754 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 11 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K020096 (Institut Straumann AG, 2002) has gone furthest, with 516 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 abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of…
Read the full statement (138 words)
The abutment is placed into the dental implant to provide support for a prosthetic
restoration such as a crown or bridge. The titanium temporary posts are screwed
into the dental implants and serve as a base for a temporary prosthetic restoration.
The plastic burn-out copings provide a cast inner surface for mating with the
abutment and implant and are for use in casting restorations directly from
porcelain-fused-to-metal alloy without the use of machined metal components.
The healing cap and closure screw are titanium devices which are mounted onto
the dental implant before the soft tissue is sutured in place around the implant and
which are intended to protect the inner configuration of the implant. The healing
cap also protects the outer 45° shoulder of the implant during the healing phase
and helps stabilize and maintain the soft tissue.
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/K013798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013798: Prosthetic Accessories to the Iti Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013798
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026