510(k) · Cleared
ClearedSimpler Mini Implant, Models SM 5002, SM 5003, SM 5004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simpler One Stop · DZE Implant, Endosseous, Root-Form
Cleared on Mar 23, 2009 as substantially equivalent to K073645 (659543 BC, Ltd., 2008) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.
- Decided
- Mar 23, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K021045 (2002). 7 ancestors in all, the oldest K974856 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK021045 Era ImplantSterngold · 2002
- 2 generations backK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
- 1 generation backK073645 Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM…659543 BC, Ltd. · 2008
- This deviceK083886 Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop · 2009
- Descendant · cites it directly · 0 of its ownK121281 Simpli Simpler Implant SystemSimpler Implant Solutions · 2013
- Descendant · cites it directly · 0 of its ownK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021045 | Era Implant | Sterngold | 2002 | — |
| −2 | K070601 | Mini Drive-Lock Dental Implant System | Intra-Lock International | 2007 | — |
| −1 | K073645 | Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004… | 659543 BC, Ltd. | 2008 | — |
| 0 (this device) | K083886 | Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004 | Simpler One Stop | 2009 | — |
| +1 | K121281 | Simpli Simpler Implant System | Simpler Implant Solutions | 2013 | — |
| +1 | K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K073645 | Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MMSummary page 1…ler Mini Implants Common Name: Mini Implants. Classification Name: Endosseous Dental Implants. Legally marketed devices to which S.E. is claimed K073 645 Simpler Mini Implants K974856 Simpler Threaded Implants K031 106 Imtec Sendax. MDI and MDI Plus Description: The… | 2008 |
| * | K974856 | 3.25MM Simpler Threaded Dental ImplantSummary page 1…Mini Implants. Classification Name: Endosseous Dental Implants. Legally marketed devices to which S.E. is claimed K073 645 Simpler Mini Implants K974856 Simpler Threaded Implants K031 106 Imtec Sendax. MDI and MDI Plus Description: The HA coated Simpler Mini Implants (K 08… | 1998 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 1…Endosseous Dental Implants. Legally marketed devices to which S.E. is claimed K073 645 Simpler Mini Implants K974856 Simpler Threaded Implants K031 106 Imtec Sendax. MDI and MDI Plus Description: The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Imp… | 2003 |
| † | K894593 | Bonefit Hollow Cylinder Implants | 1990 |
| † | K894595 | Bonefit R Screw Implants | 1990 |
What descends from it? (2)
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?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K121281 (Simpler Implant Solutions, 2013) has gone furthest, with 0 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. 2009, 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 Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083886: Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083886
Report an extraction error
Are you the manufacturer?
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