510(k) · Cleared
ClearedNeodent Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jjgc Industria E Comercio DE Materiais Dentarios S · DZE Implant, Endosseous, Root-Form
Cleared on May 17, 2013 as substantially equivalent to K101945 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2011) and 8 other predicates after a 231-day review. Its family tree reaches back 11 generations to 1996. 127 later devices descend from it.
- Decided
- May 17, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K960026 (1996). 116 ancestors in all, the oldest K874590 (1988). 127 later devices descend from it, 9 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · cites it directly · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · cites it directly · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- Descendant · cites it directly · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
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 backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · cites it directly123descendants
- K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · cites it directly109descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · cites it directly89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
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 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| 0 (this device) | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +1 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +1 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| +1 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 12 | 0 |
| 2022 | 14 | 0 |
| 2023 | 17 | 0 |
| 2024 | 14 | 0 |
| 2025 | 23 | 0 |
| 2026 | 12 | 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? (9)
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 |
|---|---|---|---|
| * | K101945 | Neodent Implant SystemSummary page 2…ssion are straight and have a Morse taper connection. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cl… | 2011 |
| * | K070601 | Mini Drive-Lock Dental Implant SystemSummary page 2…straight and have a Morse taper connection. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared sys… | 2007 |
| * | K080598 | Mini Drive-Lock Dental Implant System ProstheticsSummary page 2…and have a Morse taper connection. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to in… | 2008 |
| * | K073343 | Ace Surgical Secure-Mini Implant System, Model 09-270X-XXSummary page 2…a Morse taper connection. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new… | 2008 |
| * | K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXSummary page 2…taper connection. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new designs… | 2009 |
| * | K081653 | Mdi Mii One-Piece Implant, 2.9MMSummary page 2…ction. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new designs of implant… | 2008 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 2…EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new designs of implants and the… | 2009 |
| * | K050712 | 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantSummary page 2…CE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new designs of implants and their corres… | 2005 |
| * | K010185 | 6.0 X 5.7MM Dental ImplantSummary page 2…D DEVICE The subject device is substantially equivalent to the following predicate devices: K101945, K070601, K080598, K073343, K092594, K(081653,1K092035,1K050712, and K010185 The Neodent Implant System expands the currently cleared system to include new designs of implants and their corresponding cemen… | 2002 |
What descends from it? (127)
See all 1279 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133510 | Neodent Implant System | 2014 | 123 |
| K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua… | 2014 | 109 |
| K150367 | Neodent Implant System | 2015 | 89 |
| K150182 | Neodent Implant System- CM Drive Implants | 2015 | 18 |
| K141777 | Neodent Implant System | 2015 | 8 |
| K133696 | Neodent Implant System | 2014 | 4 |
| K220251 | Neodent Implant System - GM Narrow Implant System | 2022 | 1 |
| K150199 | Neodent Implant System | 2015 | 1 |
| K192839 | DSP Implant System | 2021 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 13 of the 116 ancestors have a recall of any class.
- Of its descendants, K133510 (Jj Industria E Comercio DE Materiais Dentarios SA, 2014) has gone furthest, with 123 descendants of its own.
- 13 other devices also cite its predicate K101945.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to
provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be, used
with single-stage ar twa-stage procedures, for single or multiple unit restorations, and may be loaded
immediately when good primary stability is achieved and with appropriate occlusal loading.
Titamax WS implant is indicated far a delayed loading protocol.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or
retention of overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123022: Neodent Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123022
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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