510(k) · Cleared
ClearedDB Precision Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Driskell Bioengineering · DZE Implant, Endosseous, Root-Form
Cleared on Oct 31, 1985 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 31, 1985
- Review
- 51 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK853788 DB Precision Implant SystemDriskell Bioengineering · 1985
- 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 · 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 4 of 4 · See all- K991250Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001 · cites it directly2descendants
- K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012 · 2 generations on1descendant
- 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) | K853788 | DB Precision Implant System | Driskell Bioengineering | 1985 | — |
| +1 | K991250 | Quantum Versatility Implant System | Quantum Bioengineering, Ltd. | 2001 | — |
| +2 | K112279 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2012 | — |
| +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 |
|---|---|---|
| 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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/K853788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K853788: DB Precision Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853788
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026