510(k) · Cleared
ClearedStraumann RC Temporary 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 Feb 12, 2010 as substantially equivalent to K070478 (Straumann Manufacturing, Inc., 2007) after a 136-day review. Its family tree reaches back 7 generations to 1990. 97 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894844 (1990). 16 ancestors in all. 97 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 5 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 4 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 3 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 2 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 1 generation backK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- This deviceK093027 Straumann RC Temporary AbutmentsStraumann USA · 2010
- Descendant · cites it directly · 64 of its ownK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- Descendant · 2 generations on · 44 of its ownK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- Descendant · 2 generations on · 38 of its ownK161689 OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 32 of its ownK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- Descendant · 3 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K121585TS Implant SystemOsstem Implant Co., Ltd. · 2013 · cites it directly64descendants
- K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014 · 2 generations on44descendants
- K161689OSSTEM Implant System - AbutmentOsstem Implant Co., Ltd. · 2017 · 2 generations on38descendants
- K160670ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017 · 2 generations on32descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −5 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −4 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −3 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K093027 | Straumann RC Temporary Abutments | Straumann USA | 2010 | — |
| +1 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| +2 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| +2 | K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017 | 2 |
| +2 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| +3 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 19 | 0 |
| 2024 | 14 | 0 |
| 2025 | 8 | 0 |
| 2026 | 9 | 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? (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 |
|---|---|---|---|
| * | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Summary page 1…ous implants Regulation Number:, §872.3630 3. Legally Marketed Device to which Equivalence is.Claimed (Predicate Device) RC Temporary Abutments, K070478 4. Description of the Device The Straumann Dental Implant System Is an integrated system of endosseous dental imp… | 2007 |
What descends from it? (97)
See all 975 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 20 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K121585 (Osstem Implant Co., Ltd., 2013) has gone furthest, with 64 descendants of its own.
- 3 other devices also cite its predicate K070478.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Straumann RC Temporary Abutments are indicated for use in Straumann
RO Bone Level Implants for temporary restorations of single crowns and bridges
for up to six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093027 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093027: Straumann RC Temporary Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093027
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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