510(k) · Cleared
ClearedNUVO IF 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.A. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 18, 2020 as substantially equivalent to K101945 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2011) after a 206-day review. Its family tree reaches back 9 generations to 1990. 6 later devices descend from it.
- Decided
- Jun 18, 2020
- Review
- 206 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 51 ancestors in all, the oldest K894844 (1990). 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- This deviceK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
- Descendant · cites it directly · 5 of its ownK203309 NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021
- Descendant · 2 generations on · 2 of its ownK233857 Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024
- Descendant · 3 generations on · 1 of its ownK250614 Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2025
- Descendant · 2 generations on · 1 of its ownK220251 Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2022
- Descendant · 4 generations on · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 2 generations backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- 1 generation backK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- This deviceK193234 NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A. · 2021 · cites it directly5descendants
- K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A. · 2024 · 2 generations on2descendants
- K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A. · 2025 · 3 generations on1descendant
- K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2022 · 2 generations on1descendant
- K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −2 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| −1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| 0 (this device) | K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020 | — |
| +1 | K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2021 | — |
| +2 | K233857 | Neodent Implant System – Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2024 | — |
| +3 | K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2025 | — |
| +2 | K220251 | Neodent Implant System - GM Narrow Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2022 | — |
| +4 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K101945 | Neodent Implant SystemSummary page 5…stria e Comércio de Materiais Dentários S.A. Page 1 of 22 PREDICATE DEVICE INFORMATION Primary Predicate Device K101945 – Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA Reference P… | 2011 |
| † | K150203 | Medentika CAD/CAM Abutments | 2015 |
| † | K150367 | Neodent Implant System | 2015 |
| † | K153624 | Neodent Implant System | 2016 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K173902 | Neodent Implant System – GM Line | 2018 |
| † | K190040 | Straumann BLX Line Extension - New Abutments | 2019 |
| † | K190718 | Zygomatic Implants | 2019 |
| † | K191191 | Neodent Implant System - Temporary Abutments | 2019 |
| † | K192229 | Neodent Implant System- GM Titanium Base for Bridge | 2019 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203309 | NUVO CF Implant System | 2021 | 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 30 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 51 ancestors have a recall of any class.
- Of its descendants, K203309 (JJGC Indústria e Comércio de Materiais Dentários S.A., 2021) has gone furthest, with 5 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. 2020, 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?
Indications for Use for NUVO IF Implants and conventional abutments: The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order 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…
Read the full statement (280 words)
Indications for Use for NUVO IF Implants and conventional abutments:
The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order 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.
The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.
The Attachment Equator and Attachment Removable Prosthesis abutments are indicated for the attachment of full or partial dentures to NUVO implants.
Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:
Titanium Base Abutment is a titanium base placed onto 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 or screw-retained single or multi-unit restorations or screw-retained single restorations.
All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.
Indications for Use for CARES® Abutment IF:
The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for screw-retained or cement-retained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193234: NUVO IF 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/K193234
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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