510(k) · Cleared
ClearedHydroxylapatite Coated Saber Tech Series I & Series II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saber Technology, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 12, 1994 after a 718-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 12, 1994
- Review
- 718 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK924112 Hydroxylapatite Coated Saber Tech Series I & Series IISaber Technology, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK991250 Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001
- Descendant · 2 generations on · 1 of its ownK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK980442 Crystal and Crystal-Seal Implants SystemCrystal Medical Technology · 1998
- Descendant · 2 generations on · 0 of its ownK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK034067 Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K991250Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001 · cites it directly2descendants
- K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012 · 2 generations on1descendant
- K980442Crystal and Crystal-Seal Implants SystemCrystal Medical Technology · 1998 · cites it directly1descendant
- K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013 · 2 generations on0descendants
- K034067Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924112 | Hydroxylapatite Coated Saber Tech Series I & Series II | Saber Technology, Inc. | 1994 | — |
| +1 | K991250 | Quantum Versatility Implant System | Quantum Bioengineering, Ltd. | 2001 | — |
| +2 | K112279 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2012 | — |
| +1 | K980442 | Crystal and Crystal-Seal Implants System | Crystal Medical Technology | 1998 | — |
| +2 | K130787 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2013 | — |
| +1 | K034067 | Zti Implants System, DRM Implants | Drm Research Laboratories, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
3 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, K991250 (Quantum Bioengineering, Ltd., 2001) has gone furthest, with 2 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.
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 | — |
https://510kreport.com/device/K924112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924112: Hydroxylapatite Coated Saber Tech Series I & Series II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924112
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026