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 · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 13, 2015 as substantially equivalent to K120822 (Institut Straumann AG, 2012) and 5 other predicates after a 151-day review. Its family tree reaches back 14 generations to 1996. 89 later devices descend from it.
- Decided
- Jul 13, 2015
- Review
- 151 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K960026 (1996). 238 ancestors in all, the oldest K871863 (1987). 89 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations between
- 3 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 2 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 1 generation backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- This deviceK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Show all 14 generations
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 12 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 11 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 7 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 6 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 5 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 4 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 3 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 2 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 1 generation backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- This deviceK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −13 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −7 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −6 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −5 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −4 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −3 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −2 | 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 | — |
| 0 (this device) | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 11 | 0 |
| 1996 | 15 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 10 | 0 |
| 2001 | 16 | 0 |
| 2002 | 18 | 0 |
| 2003 | 13 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 12 | 0 |
| 2009 | 8 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 21 | 0 |
| 2026 | 11 | 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 30.7 · 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? (6)
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 |
|---|---|---|---|
| * | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Summary page 6…UIVALENCE TO MARKETED DEVICE Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices: K120822, Straumann® CARES® Variobase™ Abutments, Institut Straumann AG; K052272, Straumann C.A.R.E.S. Titanium Abutment, Institut Strauma… | 2012 |
| * | K052272 | Straumann Computer Aided Restoration ServiceSummary page 6…ivalent in indications and design principles to the following legally marketed predicate devices: K120822, Straumann® CARES® Variobase™ Abutments, Institut Straumann AG; K052272, Straumann C.A.R.E.S. Titanium Abutment, Institut Straumann AG; K133421, Straumann® Magellan™ Abutment System, Institut Straumann… | 2006 |
| * | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewSummary page 6…rketed predicate devices: K120822, Straumann® CARES® Variobase™ Abutments, Institut Straumann AG; K052272, Straumann C.A.R.E.S. Titanium Abutment, Institut Straumann AG; K133421, Straumann® Magellan™ Abutment System, Institut Straumann AG; K133592, Neodent Implant System, Neodent USA, Inc.; K123022, Neoden… | 2014 |
| * | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Summary page 5…gle or multi-unit restorations. DEVICE DESCRIPTION The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other a… | 2014 |
| * | K123022 | Neodent Implant SystemSummary page 5…-retained single or multi-unit restorations. DEVICE DESCRIPTION The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws… | 2013 |
| * | K101945 | Neodent Implant SystemSummary page 5…or cement-retained single or multi-unit restorations. DEVICE DESCRIPTION The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutme… | 2011 |
What descends from it? (89)
See all 893 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 19 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 27 of the 238 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 descendants of its own.
- 8 other devices also cite its predicate K120822.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.
PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150367 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150367: Neodent Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150367
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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