510(k) · Cleared
ClearedNobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Dec 28, 2007 as substantially equivalent to K031345 (Nobel Biocare Uas, Inc., 2003) after a 275-day review. Its family tree reaches back 2 generations to 2003. 43 later devices descend from it.
- Decided
- Dec 28, 2007
- Review
- 275 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023952 (2003). 43 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK023952 Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc. · 2003
- 1 generation backK031345 Nobel Direct, Models 30937, 30938Nobel Biocare Uas, Inc. · 2003
- This deviceK070857 Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB · 2007
- Descendant · cites it directly · 42 of its ownK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- Descendant · 2 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · 3 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · 2 generations on · 7 of its ownK083067 MS SystemOsstem Implant Co., Ltd. · 2009
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008 · cites it directly42descendants
- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 2 generations on30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 3 generations on8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 3 generations on7descendants
- K083067MS SystemOsstem Implant Co., Ltd. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023952 | Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite | Nobel Biocare Uas, Inc. | 2003 | — |
| −1 | K031345 | Nobel Direct, Models 30937, 30938 | Nobel Biocare Uas, Inc. | 2003 | — |
| 0 (this device) | K070857 | Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM | Nobel Biocare AB | 2007 | — |
| +1 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| +2 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +3 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +3 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +2 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K031345 | Nobel Direct, Models 30937, 30938 | 2003 |
What descends from it? (43)
See all 431 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080594 | MS System (Narrow Ridge) | 2008 | 42 |
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 4 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080594 (Osstem Implant Co., Ltd., 2008) has gone furthest, with 42 descendants of its own.
- 4 other devices also cite its predicate K031345.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070857: Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070857
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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