510(k) · Cleared
ClearedSeven Implants; Biocom Implants; Lance Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mis - Implant Technologies, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 15, 2011 as substantially equivalent to K063779 (Astra Tech, Inc., 2007) after a 331-day review. Its family tree reaches back 1 generation to 2007. 49 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 331 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K063779 (2007). 49 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK063779 Osseospeed 4.0S-6MM, Model 24619Astra Tech, Inc. · 2007
- This deviceK103089 Seven Implants; Biocom Implants; Lance ImplantsMis - Implant Technologies, Ltd. · 2011
- Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · cites it directly · 11 of its ownK180282 MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018
- Descendant · cites it directly · 8 of its ownK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
- K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd. · 2018 · cites it directly11descendants
- K172225Atlantis Abutment for MIS ImplantDentsply Sirona · 2017 · cites it directly8descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063779 | Osseospeed 4.0S-6MM, Model 24619 | Astra Tech, Inc. | 2007 | — |
| 0 (this device) | K103089 | Seven Implants; Biocom Implants; Lance Implants | Mis - Implant Technologies, Ltd. | 2011 | — |
| +1 | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +2 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +1 | K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies, Ltd. | 2018 | — |
| +1 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| +3 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K042637 | FDA’s K042637 is The 5.0 X 6.0MM Dental Implant Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K063779 | Osseospeed 4.0S-6MM, Model 24619Summary page 2…02130; Boston, Massachusetts, Astra Tech cleared under 510O(k) K(063779 from 6 min implant osseoSpeed 4.OS - 02451.… | 2007 |
What descends from it? (49)
See all 498 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K180282 | MIS Internal Hex Dental Implant System | 2018 | 11 |
| K172225 | Atlantis Abutment for MIS Implant | 2017 | 8 |
| K133362 | SGS Dental Implant | 2014 | 2 |
| K123512 | Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MM | 2013 | 2 |
| K161497 | Dental Implants and Abutments | 2016 | 1 |
| K133884 | Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MM | 2014 | 1 |
| K120530 | Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental… | 2012 | 0 |
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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
MIS short implants are to be used only with straight abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103089: Seven Implants; Biocom Implants; Lance Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103089
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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