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 Aug 2, 2010 as substantially equivalent to K002037 (Lifecore Biomedical, Inc., 2001) and 6 other predicates after a 94-day review. Its family tree reaches back 6 generations to 1990. 181 later devices descend from it.
- Decided
- Aug 2, 2010
- Review
- 94 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K894595 (1990). 34 ancestors in all, the oldest K894844 (1990). 181 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 2 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 1 generation backK050406 Nobelspeedy ImplantsNobel Biocare AB · 2005
- This deviceK101207 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010
- Descendant · cites it directly · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · 2 generations on · 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 · 2 generations on · 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
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly180descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
- 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 · 2 generations on115descendants
- K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · cites it directly109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050406 | Nobelspeedy Implants | Nobel Biocare AB | 2005 | — |
| 0 (this device) | K101207 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010 | — |
| +1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +2 | 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 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K002037 | Lifecore Biomedical Dental Implant SystemsSummary page 2…e devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Lifecore Biomedical Dental Implant Systems cleared under K002037, Nobel Biocare NOBELSPEED~rm Implants cleared under K050406, Straumann ITIO Dental Implant System cleared under K033922,… | 2001 |
| * | K050406 | Nobelspeedy ImplantsSummary page 2…ntially equivalent to pre-amendment devices: Lifecore Biomedical Dental Implant Systems cleared under K002037, Nobel Biocare NOBELSPEED~rm Implants cleared under K050406, Straumann ITIO Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K041295, St… | 2005 |
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 2…ical Dental Implant Systems cleared under K002037, Nobel Biocare NOBELSPEED~rm Implants cleared under K050406, Straumann ITIO Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K041295, Straumann UCLA Gold Abutment cleared under K022859, Astra Tech… | 2004 |
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 2…el Biocare NOBELSPEED~rm Implants cleared under K050406, Straumann ITIO Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K041295, Straumann UCLA Gold Abutment cleared under K022859, Astra Tech Fixture MicromhreadTM OsseoSpeed TM cleared under K053384… | 2004 |
| * | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant SystemSummary page 2…Straumann ITIO Dental Implant System cleared under K033922, Straumann synOcta® Prosthetics cleared under K041295, Straumann UCLA Gold Abutment cleared under K022859, Astra Tech Fixture MicromhreadTM OsseoSpeed TM cleared under K053384, and Thommen Medical SPI® ART Abutment cleared unde… | 2002 |
| * | K053384 | Fixature Microthread Osseospeed, a Component of the Astra Tech Implant SystemSummary page 2…mann synOcta® Prosthetics cleared under K041295, Straumann UCLA Gold Abutment cleared under K022859, Astra Tech Fixture MicromhreadTM OsseoSpeed TM cleared under K053384, and Thommen Medical SPI® ART Abutment cleared under K073 141. The subject device and the predicate devices have the same in… | 2006 |
| * | K073141 | Spi Art AbutmentSummary page 2…LA Gold Abutment cleared under K022859, Astra Tech Fixture MicromhreadTM OsseoSpeed TM cleared under K053384, and Thommen Medical SPI® ART Abutment cleared under K073 141. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2007 |
What descends from it? (181)
See all 1816 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101945 | Neodent Implant System | 2011 | 180 |
| K133510 | Neodent Implant System | 2014 | 123 |
| K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua… | 2014 | 109 |
| K173902 | Neodent Implant System – GM Line | 2018 | 3 |
| K183024 | Implacil Implant System | 2020 | 2 |
| 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 20 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K101945 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2011) has gone furthest, with 180 descendants of its own.
- 2 other devices also cite its predicate K002037.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 occiusal loading. Multiple tooth applications may be rigidly splinted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101207: Neodent 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/K101207
Report an extraction error
Are you the manufacturer?
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