510(k) · Cleared
ClearedNeodent Scannable Healing Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
JJGC Indústria e Comércio de Materiais Dentários S.A. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 15, 2026 as substantially equivalent to K163194 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2017) after a 189-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jun 15, 2026
- Review
- 189 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 89 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK253922 Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 9 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 6 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 5 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 4 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- 1 generation backK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- This deviceK253922 Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −9 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −6 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −5 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −2 | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| −1 | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | 6 |
| 0 (this device) | K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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 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? (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 |
|---|---|---|---|
| * | K163194 | Neodent Implant System - GM LineSummary page 6…510(k) Summary K253922 Predicate Device(s) Primary Predicate: K163194 Neodent Implant System – GM Line (GM healings) Reference Devices: K212730 BellaTek Encode Emergence Healing A… | 2017 |
| † | K212730 | BellaTek Encode Emergence Healing Abutments | 2021 |
| † | K182620 | MRI Compatibility for Existing Neodent Implant System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 89 ancestors have a recall of any class.
- 13 other devices also cite its predicate K163194.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253922: Neodent Scannable Healing Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253922
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026