510(k) · Cleared
ClearedP.0004 Implants
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 Oct 20, 2006 as substantially equivalent to K012757 (Straumann USA, 2001) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1990. 434 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 86 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894844 (1990). 8 ancestors in all. 434 later devices descend from it, 31 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 3 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 2 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 1 generation backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- This deviceK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- Descendant · cites it directly · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · cites it directly · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
- Descendant · cites it directly · 264 of its ownK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- Descendant · 2 generations on · 263 of its ownK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Showing 5 of 434 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 434 · See all- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · cites it directly283descendants
- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · cites it directly279descendants
- K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · cites it directly264descendants
- K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · 2 generations on263descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −3 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −2 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −1 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| 0 (this device) | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| +1 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +1 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
| +1 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| +2 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| +3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 10 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 18 | 0 |
| 2015 | 23 | 0 |
| 2016 | 25 | 0 |
| 2017 | 23 | 0 |
| 2018 | 23 | 0 |
| 2019 | 20 | 0 |
| 2020 | 35 | 0 |
| 2021 | 30 | 0 |
| 2022 | 29 | 0 |
| 2023 | 49 | 0 |
| 2024 | 51 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 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? (2)
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 |
|---|---|---|---|
| * | K012757 | Iti Dental Implant SystemSummary page 1…21 CFR 872.3640 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) ITI Tapered Dental Implant, K012757 ITI Dental Implant System, synOcta Meso Abutment, K033243 4. Description of the Device The P.004 Imp… | 2001 |
| * | K033243 | Iti Synocta Meso AbutmentsSummary page 1…s to which Equivalence is Claimed (Predicate Devices) ITI Tapered Dental Implant, K012757 ITI Dental Implant System, synOcta Meso Abutment, K033243 4. Description of the Device The P.004 Implant is an addition to the currently distributed Straumann… | 2003 |
What descends from it? (434)
See all 43431 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | 2007 | 283 |
| K072679 | P.004 Abutments | 2007 | 279 |
| K072151 | P.004 RC Cares Titanium and Ceramic Abutments | 2007 | 264 |
| K071585 | P.004 Healing Abutments and Closure Screws | 2007 | 233 |
| K083550 | Straumann Dental Implant System | 2009 | 228 |
| K070549 | Straumann P.004 RC Gold Abutment | 2007 | 225 |
| K072497 | P.004 NC Gold Abutment for Crowns | 2007 | 224 |
| K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | 2007 | 205 |
| K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | 2012 | 124 |
| K123784 | Straumann Dental Implant System | 2013 | 122 |
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 16 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K070478 (Straumann Manufacturing, Inc., 2007) has gone furthest, with 283 descendants of its own.
- 10 other devices also cite its predicate K012757.
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 P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandibular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly…
Read the full statement (123 words)
The P.004 Implants are intended for immediate, delayed or conventional
placement in the maxilla and/or mandibular arches to support crowns bridges or
overdentures in edentulous or partially edentulous patients.
They are intended for immediate function on single-tooth and/or multiple tooth
applications when good primary stability is achieved and with appropriate
occlusal loading, to restore chewing function. Multiple tooth applications may be
rigidly splinted. In the case of edentulous patients, 4 or more implants must be
used.
Abutments are intended to be placed into dental implants to provide support for
prosthetic reconstructions such as crowns or bridges. Meso abutments are
indicated for cemented restorations particularly 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/K062129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062129: P.0004 Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062129
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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