510(k) · Cleared
ClearedSimpact Endosseous Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simpact, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 7, 2008 as substantially equivalent to K081226 (Simpact, LLC, 2008) after a 15-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Nov 7, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K960026 (1996). 44 ancestors in all, the oldest K894595 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK081226 Simpact Implant SystemSimpact, LLC · 2008
- This deviceK083141 Simpact Endosseous Dental Implant SystemSimpact, LLC · 2008
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 2 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 1 generation backK081226 Simpact Implant SystemSimpact, LLC · 2008
- This deviceK083141 Simpact Endosseous Dental Implant SystemSimpact, LLC · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −2 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −1 | K081226 | Simpact Implant System | Simpact, LLC | 2008 | — |
| 0 (this device) | K083141 | Simpact Endosseous Dental Implant System | Simpact, LLC | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K081226 | Simpact Implant SystemSummary page 2…ant and abutment and Number 21 CFR 872.3630 21 CFR 872.3640 Product Code DZE, NHA Predicate Devices SIMPACT K081226 Device Description The SIMPACT Endosseous Dental Implant System, Line Extension Intended Use… | 2008 |
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 12 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 5 of the 44 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework. The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of…
Read the full statement (153 words)
Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.
The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.
The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083141: Simpact Endosseous Dental 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/K083141
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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