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 Jan 26, 2011 as substantially equivalent to K003226 (Lifecore Biomedical, Inc., 2001) and 9 other predicates after a 198-day review. Its family tree reaches back 8 generations to 1990. 180 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 8 generations to K894595 (1990). 50 ancestors in all, the oldest K894844 (1990). 180 later devices descend from it, 14 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 1 generation backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- This deviceK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · cites it directly · 127 of its ownK123022 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 · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 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
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · See all- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · cites it directly127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · cites it directly123descendants
- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · cites it directly115descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −1 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| 0 (this device) | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +1 | 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 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 17 | 0 |
| 2021 | 19 | 0 |
| 2022 | 18 | 0 |
| 2023 | 24 | 0 |
| 2024 | 19 | 0 |
| 2025 | 27 | 0 |
| 2026 | 17 | 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? (10)
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 |
|---|---|---|---|
| * | K003226 | The Lifecore Stage-1 Single Stage RBM Dental Implant SystemSummary page 2…as been determined by FDA to be substantially equivalent to pre-amendment devices: Lifecore Biomedical Stage-I Single Stage RBM Dental Implant System cleared under K003226, Lifecore Biomedical Stage-lAngled Abutment System cleared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental… | 2001 |
| * | K032495 | The Lifecore Stage-1 Angled Abutment SystemSummary page 2…vices: Lifecore Biomedical Stage-I Single Stage RBM Dental Implant System cleared under K003226, Lifecore Biomedical Stage-lAngled Abutment System cleared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental Implant System cleared under K083 805, Nobel Biocare NOBELSPEEDYTM Im… | 2003 |
| * | K083805 | Ankylos C/X Dental Implant SystemSummary page 2…K003226, Lifecore Biomedical Stage-lAngled Abutment System cleared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental Implant System cleared under K083 805, Nobel Biocare NOBELSPEEDYTM Implants cleared under K050406, Nobel IBiocare Esthetic Zirconia Abutment cleared uinder K03 1… | 2009 |
| * | K050406 | Nobelspeedy ImplantsSummary page 2…eared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental Implant System cleared under K083 805, Nobel Biocare NOBELSPEEDYTM Implants cleared under K050406, Nobel IBiocare Esthetic Zirconia Abutment cleared uinder K03 1719, Straulmann ITI® Dental Implant System cleared under K03… | 2005 |
| * | K031719 | Esthetic Zirconia AbutmentSummary page 2…ntal Implant System cleared under K083 805, Nobel Biocare NOBELSPEEDYTM Implants cleared under K050406, Nobel IBiocare Esthetic Zirconia Abutment cleared uinder K03 1719, Straulmann ITI® Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K04 1295, Str… | 2003 |
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 2…OBELSPEEDYTM Implants cleared under K050406, Nobel IBiocare Esthetic Zirconia Abutment cleared uinder K03 1719, Straulmann ITI® Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K04 1295, Straumannm UCLA Gold Abutment cleared under K022859, and Astra T… | 2004 |
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 2…ocare Esthetic Zirconia Abutment cleared uinder K03 1719, Straulmann ITI® Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K04 1295, Straumannm UCLA Gold Abutment cleared under K022859, and Astra Tech Fixture MicroThreadTM OsseoSpeedTM cleared under K0533… | 2004 |
| * | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant SystemSummary page 2…Straulmann ITI® Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K04 1295, Straumannm UCLA Gold Abutment cleared under K022859, and Astra Tech Fixture MicroThreadTM OsseoSpeedTM cleared under K053384, JJGC lnd~stria eCom~rcio de Materiais DentArios S… | 2002 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 2…n synOcta® Prosthetics cleared under K04 1295, Straumannm UCLA Gold Abutment cleared under K022859, and Astra Tech Fixture MicroThreadTM OsseoSpeedTM cleared under K053384, JJGC lnd~stria eCom~rcio de Materiais DentArios SA Neodent Implant System cleared under K 101207. The subject device and… | 2006 |
| * | K101207 | Neodent Implant System Cleared while this submission was under review Summary page 2…and Astra Tech Fixture MicroThreadTM OsseoSpeedTM cleared under K053384, JJGC lnd~stria eCom~rcio de Materiais DentArios SA Neodent Implant System cleared under K 101207. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2010 |
What descends from it? (180)
See all 18014 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123022 | Neodent Implant System | 2013 | 127 |
| K133510 | Neodent Implant System | 2014 | 123 |
| K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw | 2014 | 115 |
| K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua… | 2014 | 109 |
| K150367 | Neodent Implant System | 2015 | 89 |
| K163194 | Neodent Implant System - GM Line | 2017 | 30 |
| K170398 | S.I.N. Dental Implant System | 2017 | 17 |
| K200992 | S.I.N. Dental Implant System | 2020 | 7 |
| K193234 | NUVO IF Implant System | 2020 | 6 |
| K201491 | Neodent Implant System - Zirconia Implant System | 2020 | 5 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 50 ancestors have a recall of any class.
- Of its descendants, K123022 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2013) has gone furthest, with 127 descendants of its own.
- 4 other devices also cite its predicate K003226.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101945 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101945: 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/K101945
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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