510(k) Report

510(k) · Cleared

Cleared

Simpler Toadstool Mini Implant

K092674510(k) TraditionalCleared Dec 28, 2009118-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pan Global Implant · DZE Implant, Endosseous, Root-Form

Cleared on Dec 28, 2009 as substantially equivalent to K083886 (Simpler One Stop, 2009) and 2 other predicates after a 118-day review. Its family tree reaches back 4 generations to 1995.

Decided
Dec 28, 2009
Review
118 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K935544 (1995). 15 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2003: 2 other ancestors2008: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors2007: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestorK935544 · 3I Standard Threaded/Self-Tapping Threaded Implants Modification · Implant Innovations International, Inc. · 1995K013570 · Osseotite Dental Implants · Implant Innovations, Inc. · 2001K031055 · Iti Dental Implant System · Straumann USA · 2003K050586 · Leone Implant System · Leone S.P.A. · 20061995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 4 other ancestors K050586 · Leone Implant System · Leone S.P.A. · 2006K031055 · Iti Dental Implant System · Straumann USA · 2003K013570 · Osseotite Dental Implants · Implant Innovations, Inc. · 2001K935544 · 3I Standard Threaded/Self-Tapping Threaded Implants Modification · Implant Innovations International, Inc. · 19950
  1. Root · 4 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
  2. 3 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
  3. 2 generations backK031055 Iti Dental Implant SystemStraumann USA · 2003
  4. 1 generation backK050586 Leone Implant SystemLeone S.P.A. · 2006
  5. This deviceK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K9355443I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc.1995—
−3K013570Osseotite Dental ImplantsImplant Innovations, Inc.2001—
−2K031055Iti Dental Implant SystemStraumann USA2003—
−1K050586Leone Implant SystemLeone S.P.A.2006—
0 (this device)K092674Simpler Toadstool Mini ImplantPan Global Implant2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200010
200210
200320
200410
200710
200810
200910
FIG. 1 — Lineage of K092674, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K083886Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004
Summary page 1
…n Name: Simpler Toadstool Mini Implants & Simpler Toadstool Mini Implant Classification: Endosseous Dental Implants Legally marketed devices to which S.E. Isclaimed K083886: Simpler Mini Implants K031 106: lmtec Sendax MDI and MDI plus K050586: Leone Implant System K70601: Mini Drive-Lock Imp…
Simpler One Stop2009—
*K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX
Summary page 1
…lants & Simpler Toadstool Mini Implant Classification: Endosseous Dental Implants Legally marketed devices to which S.E. Isclaimed K083886: Simpler Mini Implants K031 106: lmtec Sendax MDI and MDI plus K050586: Leone Implant System K70601: Mini Drive-Lock Implant Descripflon The Simpler Toadst…
Imtec Corp.20031
*K050586Leone Implant System
Summary page 1
…sification: Endosseous Dental Implants Legally marketed devices to which S.E. Isclaimed K083886: Simpler Mini Implants K031 106: lmtec Sendax MDI and MDI plus K050586: Leone Implant System K70601: Mini Drive-Lock Implant Descripflon The Simpler Toadstool Minis and the Simpler HA Toadstool Min…
Leone S.P.A.2006—
Kept off the family treeK070601FDA’s K070601 is Mini Drive-Lock Dental Implant System
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Intra-Lock International2007—

Also cleared against K083886: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • 1 other device also cites its predicate K083886.

How does its category compare?

All DZE devices

DZE 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

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there isgood primary stability and an minimal occlusal load. These implants may also be used for temporary soft tissue overdlenture support for partial and fully edlentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentulism as an alternative to more invasive surgery involving conventional implants.

Indications for use as stated in the FDA summary.

Also cleared against K083886

1 other device cites the same predicate.

  • K121281Simpli Simpler Implant SystemSimpler Implant Solutions · 2013

More from Pan Global Implant

2 FDA decisions under this applicant name. See the company

  • K093975Simpler Toadstool Abutment, Model S19000-S19009Pan Global Implant · 2010

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K092674 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092674: Simpler Toadstool Mini Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092674

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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