510(k) Report

510(k) · Cleared

Cleared

Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident

K012473510(k) TraditionalCleared Sep 11, 2002405-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

Vident · DZE Implant, Endosseous, Root-Form

Cleared on Sep 11, 2002 after a 405-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 266 later devices descend from it.

Decided
Sep 11, 2002
Review
405 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 2 descendants cleared2015: 13 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2012: 3 descendants cleared2014: 9 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2013: 3 descendants cleared2018: 15 descendants cleared2017: 12 descendants cleared2023: 32 descendants cleared2020: 21 descendants cleared2021: 23 descendants cleared2025: 28 descendants cleared2016: 13 descendants cleared2024: 36 descendants cleared2019: 14 descendants cleared2022: 19 descendants cleared2026: 14 descendants cleared200020052010201520202025
  1. This deviceK012473 Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by VidentVident · 2002
  2. Descendant · cites it directly · 265 of its ownK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
  3. Descendant · 2 generations on · 264 of its ownK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
  4. Descendant · 3 generations on · 263 of its ownK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
  5. Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
  6. Descendant · 2 generations on · 171 of its ownK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008

Showing 5 of 266 descendants. See all descendants

Descendants cleared per year

2007: 22008: 22009: 12010: 22011: 42012: 32013: 32014: 92015: 132016: 132017: 122018: 152019: 142020: 212021: 232022: 192023: 322024: 362025: 282026: 14
2007high 36 (2024) · low 1 (2009)2026

Most influential descendants

Showing 5 of 266 · See all
  • K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA · 2007 · cites it directly265descendants
  • K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · 2 generations on264descendants
  • K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · 3 generations on263descendants
  • K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants
  • K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · 2 generations on171descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012473Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by VidentVident2002—
+1K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA2007—
+2K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA20071
+3K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20081
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010—
+2K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200820
200910
201020
201140
201230
201330
201490
2015130
2016130
2017120
2018150
2019140
2020210
2021230
2022190
2023320
2024360
2025280
2026140
FIG. 1 — Lineage of K012473, 2002–2026Source: 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 510(k) statement (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. #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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (266)

See all 266

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

NumberDeviceApplicantDecidedDescendants
K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA2007265

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, K061277 (Straumann USA, 2007) has gone furthest, with 265 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—

What is it indicated for?

Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.

The IT10 ceramic coping is intended to be seated on the implantlabutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.

Indications for use as stated in the FDA 510(k) statement.

More from Vident

36 FDA decisions under this applicant name. See the company

  • K063768Titanium Scalloped AbutmentVident · 2007
  • K060441Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX, VX62 XXXX; Vita VM…Vident · 2006
  • K052710Vita VM7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX, VX62 XXXX; Vita VM 9,Vident · 2006
  • K052130Vita in-Ceram 2000 AL Cubes for Inlab, Models AL20/AL40Vident · 2005
  • K050362Vita PM 7 (20 Gram Bottles), Vita PM 7 (50 Gram Bottles)Vident · 2005

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K012473 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012473: Vident Hextop, Synocta in-Ceram Blank/Coping Manufactured by Vident.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012473

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 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026