510(k) · Cleared
ClearedSimpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
659543 BC, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 21, 2008 as substantially equivalent to K070601 (Intra-Lock International, 2007) and 1 other predicate after a 300-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 300 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021045 (2002). 5 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK021045 Era ImplantSterngold · 2002
- 1 generation backK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
- This deviceK073645 Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM…659543 BC, Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK083886 Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop · 2009
- Descendant · 2 generations on · 0 of its ownK121281 Simpli Simpler Implant SystemSimpler Implant Solutions · 2013
- Descendant · 2 generations on · 0 of its ownK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
Most influential descendants
Showing 3 of 3 · See all- K083886Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop · 2009 · cites it directly2descendants
- K121281Simpli Simpler Implant SystemSimpler Implant Solutions · 2013 · 2 generations on0descendants
- K092674Simpler Toadstool Mini ImplantPan Global Implant · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021045 | Era Implant | Sterngold | 2002 | — |
| −1 | K070601 | Mini Drive-Lock Dental Implant System | Intra-Lock International | 2007 | — |
| 0 (this device) | K073645 | Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004… | 659543 BC, Ltd. | 2008 | — |
| +1 | K083886 | Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004 | Simpler One Stop | 2009 | — |
| +2 | K121281 | Simpli Simpler Implant System | Simpler Implant Solutions | 2013 | — |
| +2 | K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070601 | Mini Drive-Lock Dental Implant SystemSummary page 1…NAME: Endosseous Dental Implant The legally marketed devices to which we are claiming equivalence (21 CFR 807.92 (a)(3) are: Mini Drive-Lock Implant K 070601 Bicon K023705 DESCRIPTION OF THE DEVICE: This transitional implant is designed to serve as a provisional artificial root to p… | 2007 |
| * | K023705 | Bicon Transitional Implant (Bti) SystemSummary page 1…Endosseous Dental Implant The legally marketed devices to which we are claiming equivalence (21 CFR 807.92 (a)(3) are: Mini Drive-Lock Implant K 070601 Bicon K023705 DESCRIPTION OF THE DEVICE: This transitional implant is designed to serve as a provisional artificial root to provide immediate… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083886 | Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004 | 2009 | 2 |
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 6 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K083886 (Simpler One Stop, 2009) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K070601.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Transitional Implants are designed for temporary use in edentulous sites. The pimary purpose is to provide provisional prosthetic devices to protect the permanent implants firan premature loading during the healing period. They are used to support bridges and dentures. AdditIonal uses are Inter-radicular transitional applications, immediate splinting tability, fuland partial edentulism and using minimally Invasive surgical intervention The target…
Read the full statement (98 words)
The Transitional Implants are designed for temporary use in edentulous sites. The pimary purpose is to provide provisional prosthetic devices to protect the permanent implants firan premature loading during the healing period. They are used to support bridges and dentures. AdditIonal uses are Inter-radicular transitional applications, immediate splinting tability, fuland partial edentulism and using minimally Invasive surgical intervention
The target population Isdetermined when there is inadequate bone for wider Implants as wll as for patients wishing Immediate functional loading. The transitionals are to be used In a clinical site by a qualified dentist experienced in placing dental Implamn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073645: Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073645
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