510(k) · Cleared
ClearedNC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary Abutment, Cad-Temp, Pmma WN Tem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 2, 2012 as substantially equivalent to K072679 (Institut Straumann AG, 2007) and 3 other predicates after a 101-day review. Its family tree reaches back 10 generations to 1990. 1 later device descends from it.
- Decided
- Nov 2, 2012
- Review
- 101 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894595 (1990). 65 ancestors in all, the oldest K894844 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- This deviceK122192 NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment…Straumann USA, LLC · 2012
- Descendant · cites it directly · 0 of its ownK201681 Straumann Immediate Temporary AbutmentsInstitut Straumann AG · 2021
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- This deviceK122192 NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment…Straumann USA, LLC · 2012
Most influential descendants
Showing 1 of 1 · See all- K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −1 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| 0 (this device) | K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN… | Straumann USA, LLC | 2012 | — |
| +1 | K201681 | Straumann Immediate Temporary Abutments | Institut Straumann AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 30.6 · 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? (4)
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 |
|---|---|---|---|
| * | K072679 | P.004 AbutmentsSummary page 1…e: Endlosseous Dental Implant Abutment Regulation Number: §872.3630 4. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K072679, Straumann NC Temporary Abutment K070478, Straumann RC Temporary Abutment K051717, Straumann RN synOcta Temporary Abutm… | 2007 |
| * | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Summary page 1…Regulation Number: §872.3630 4. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K072679, Straumann NC Temporary Abutment K070478, Straumann RC Temporary Abutment K051717, Straumann RN synOcta Temporary Abutment Kil1357, Straumann NNC Post for Tempo… | 2007 |
| * | K051717 | RN Synocta Temporary Meso AbutmentSummary page 1…Marketed Device to which Equivalence is Claimed (Predicate Device) K072679, Straumann NC Temporary Abutment K070478, Straumann RC Temporary Abutment K051717, Straumann RN synOcta Temporary Abutment Kil1357, Straumann NNC Post for Temporary Restoration 5. Description of the Devi… | 2005 |
| * | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201681 | Straumann Immediate Temporary Abutments | 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 22 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 65 ancestors have a recall of any class.
- Of its descendants, K201681 (Institut Straumann AG, 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072679.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with
Straumann Bone Level and Tissue Level implants for temporary crown and
bridge restorations, and to maintain, stabilize and shape the soft tissue during
the healing phase for up to six months, and should be placed out of occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122192: NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary Abutment, Cad-Temp, Pmma WN Tem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122192
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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