510(k) · Cleared
ClearedOsseospeed 4.0S-6MM, Model 24619
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Tech, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 27, 2007 after a 127-day review. The FDA summary names no predicate by number. 75 later devices descend from it.
- Decided
- Apr 27, 2007
- Review
- 127 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
75 later devices descend from it, 4 citing it directly.
- This deviceK063779 Osseospeed 4.0S-6MM, Model 24619Astra Tech, Inc. · 2007
- Descendant · cites it directly · 49 of its ownK103089 Seven Implants; Biocom Implants; Lance ImplantsMis - Implant Technologies, Ltd. · 2011
- Descendant · 2 generations on · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 3 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · cites it directly · 14 of its ownK113779 Conelog Implant SystemAltatec GmbH · 2012
- Descendant · 2 generations on · 11 of its ownK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K103089Seven Implants; Biocom Implants; Lance ImplantsMis - Implant Technologies, Ltd. · 2011 · cites it directly49descendants
- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · 2 generations on25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 3 generations on14descendants
- K113779Conelog Implant SystemAltatec GmbH · 2012 · cites it directly14descendants
- K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063779 | Osseospeed 4.0S-6MM, Model 24619 | Astra Tech, Inc. | 2007 | — |
| +1 | K103089 | Seven Implants; Biocom Implants; Lance Implants | Mis - Implant Technologies, Ltd. | 2011 | — |
| +2 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +3 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +1 | K113779 | Conelog Implant System | Altatec GmbH | 2012 | — |
| +2 | K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (75)
See all 754 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?
- Of its descendants, K103089 (Mis - Implant Technologies, Ltd., 2011) has gone furthest, with 49 descendants of its own.
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 OsseoSpeed TM system is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. The device may be used equally well in a single-stage) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge…
Read the full statement (181 words)
The OsseoSpeed TM system is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. The device may be used equally well in a single-stage) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.
The fluoride-modified surface, though having a fluoride ion level far below tat needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed implants are especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed 4.0S - 6 mm implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063779 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063779: Osseospeed 4.0S-6MM, Model 24619.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063779
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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