510(k) Report

510(k) · Cleared

Cleared

Straumann Temporary Coping

K041070510(k) TraditionalCleared Jul 23, 200488-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Straumann Co. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jul 23, 2004 as substantially equivalent to K010467 (Paxmed International, 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2001. 218 later devices descend from it.

Decided
Jul 23, 2004
Review
88 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K010467 (2001). 2 ancestors in all. 218 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 1 descendant cleared2021: 22 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2015: 10 descendants cleared2008: 2 descendants cleared2014: 5 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2013: 1 descendant cleared2016: 10 descendants cleared2020: 18 descendants cleared2017: 13 descendants cleared2023: 28 descendants cleared2018: 13 descendants cleared2025: 26 descendants cleared2024: 27 descendants cleared2019: 7 descendants cleared2022: 18 descendants cleared2026: 12 descendants clearedK010467 · Universal Dental Coping (Udc) · Paxmed International · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 19 descendants4 generations forward: 11 descendants5 generations forward: 36 descendants6 generations forward: 50 descendants7 generations forward: 46 descendants8 generations forward: 22 descendants9 generations forward: 12 descendants10 generations forward: 9 descendants11 generations forward: 4 descendants12 generations forward: 2 descendants K010467 · Universal Dental Coping (Udc) · Paxmed International · 20010+5+10
  1. Root · 1 generation backK010467 Universal Dental Coping (Udc)Paxmed International · 2001
  2. This deviceK041070 Straumann Temporary CopingThe Straumann Co. · 2004
  3. Descendant · cites it directly · 205 of its ownK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
  4. Descendant · 2 generations on · 179 of its ownK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
  5. Descendant · 3 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
  6. Descendant · 4 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
  7. Descendant · 5 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015

Showing 5 of 218 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12008: 22009: 12011: 12012: 22013: 12014: 52015: 102016: 102017: 132018: 132019: 72020: 182021: 222022: 182023: 282024: 272025: 262026: 12
2005high 28 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 218 · See all
  • K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG · 2007 · cites it directly205descendants
  • K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008 · 2 generations on179descendants
  • K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 3 generations on166descendants
  • K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 4 generations on165descendants
  • K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 5 generations on129descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010467Universal Dental Coping (Udc)Paxmed International2001—
0 (this device)K041070Straumann Temporary CopingThe Straumann Co.2004—
+1K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007—
+2K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA2008—
+3K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle…Straumann USA2011—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…Institut Straumann AG2012—
+5K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200820
200910
201110
201220
201310
201450
2015100
2016100
2017130
2018130
201970
2020180
2021220
2022180
2023280
2024270
2025260
2026120
FIG. 1 — Lineage of K041070, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K010467Universal Dental Coping (Udc)
Summary page 1
…Claimed (Predicate Devices) Manufacturer Device 510 (k) Simplified Universal Dental Coping K010467 Implant Systems I Centerpulse Hex-Lock Temporary Abutment K014050 Dental Friadent…
Paxmed International2001—
*K014050Hex-Lock Temporary Abutment
Summary page 1
…510 (k) Simplified Universal Dental Coping K010467 Implant Systems I Centerpulse Hex-Lock Temporary Abutment K014050 Dental Friadent ProTect Abutment Unknown Lifecore COC Abutment Tem…
Sulzer Dental, Inc.2002—
*—ProTect Abutment
Named without a submission number
—
*—COC Abutment Temporary Cap
Named without a submission number
—

What descends from it? (218)

See all 218

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007205
K051527Spi Easy Temporary CapThommen Medical AG200511
K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K072071 (Institut Straumann AG, 2007) has gone furthest, with 205 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.

Indications for use as stated in the FDA summary.

More from The Straumann Co.

14 FDA decisions under this applicant name. See the company

  • K040646Straumann GranulesThe Straumann Co. · 2004
  • K040469The Straumann Ortho Implant SystemThe Straumann Co. · 2004
  • K993862Modus Sagittal Split PlateThe Straumann Co. · 1999
  • K962023Plastic Protection Healing CapsThe Straumann Co. · 1996
  • K960634Titanium Healing CapsThe Straumann Co. · 19961 recall

Recent decisions in NHA

The NHA category page

  • K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026
  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K041070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041070: Straumann Temporary Coping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041070

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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