510(k) Report

510(k) · Cleared

Cleared

Universal Dental Coping (Udc)

K010467510(k) TraditionalCleared Sep 28, 2001224-day reviewClass II21 CFR 872.3640

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

Paxmed International · DZE Implant, Endosseous, Root-Form

Cleared on Sep 28, 2001 after a 224-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 219 later devices descend from it.

Decided
Sep 28, 2001
Review
224 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

219 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 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 cleared200020052010201520202025
  1. This deviceK010467 Universal Dental Coping (Udc)Paxmed International · 2001
  2. Descendant · cites it directly · 218 of its ownK041070 Straumann Temporary CopingThe Straumann Co. · 2004
  3. Descendant · 2 generations on · 205 of its ownK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
  4. Descendant · 3 generations on · 179 of its ownK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
  5. Descendant · 4 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
  6. Descendant · 5 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12007: 12008: 22009: 12011: 12012: 22013: 12014: 52015: 102016: 102017: 132018: 132019: 72020: 182021: 222022: 182023: 282024: 272025: 262026: 12
2004high 28 (2023) · low 0 (2006)2026

Most influential descendants

Showing 5 of 219 · See all
  • K041070Straumann Temporary CopingThe Straumann Co. · 2004 · cites it directly218descendants
  • K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG · 2007 · 2 generations on205descendants
  • K080286Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008 · 3 generations on179descendants
  • K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 4 generations on166descendants
  • K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 5 generations on165descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200710
200820
200910
201110
201220
201310
201450
2015100
2016100
2017130
2018130
201970
2020180
2021220
2022180
2023280
2024270
2025260
2026120
FIG. 1 — Lineage of K010467, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (219)

See all 219

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041070Straumann Temporary CopingThe Straumann Co.2004218

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?

  • Of its descendants, K041070 (The Straumann Co., 2004) has gone furthest, with 218 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

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https://510kreport.com/device/K010467 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010467: Universal Dental Coping (Udc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010467

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026