510(k) Report

510(k) · Cleared

Cleared

Endure Implant, Model 3508,3511,3514,4308,4311,4314

K030243510(k) TraditionalCleared Apr 23, 200390-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

Imtec Corp. · DZE Implant, Endosseous, Root-Form

Cleared on Apr 23, 2003 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 142 later devices descend from it.

Decided
Apr 23, 2003
Review
90 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2012: 2 descendants cleared2017: 3 descendants cleared2013: 3 descendants cleared2014: 5 descendants cleared2021: 12 descendants cleared2015: 4 descendants cleared2022: 15 descendants cleared2020: 13 descendants cleared2025: 23 descendants cleared2024: 15 descendants cleared2023: 18 descendants cleared2018: 6 descendants cleared2016: 2 descendants cleared2019: 8 descendants cleared2026: 12 descendants cleared200020052010201520202025
  1. This deviceK030243 Endure Implant, Model 3508,3511,3514,4308,4311,4314Imtec Corp. · 2003
  2. Descendant · cites it directly · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
  3. Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  4. Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  5. Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  6. Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015

Showing 5 of 142 descendants. See all descendants

Descendants cleared per year

2008: 12012: 22013: 32014: 52015: 42016: 22017: 32018: 62019: 82020: 132021: 122022: 152023: 182024: 152025: 232026: 12
2008high 23 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 142 · See all
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · cites it directly141descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 3 generations on123descendants
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 3 generations on109descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030243Endure Implant, Model 3508,3511,3514,4308,4311,4314Imtec Corp.2003—
+1K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201220
201330
201450
201540
201620
201730
201860
201980
2020130
2021120
2022150
2023180
2024150
2025230
2026120
FIG. 1 — Lineage of K030243, 2003–2026Source: 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), 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? (142)

See all 142

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

NumberDeviceApplicantDecidedDescendants
K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.2008141

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, K081653 (Imtec Corp., 2008) has gone furthest, with 141 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?

To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients.

ENDURE endosseous implants are designed to become an Osseointegated prosthesis allowing the attachment of a partial or a complete prosthetic appliance in the mandible or maxilla.

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

More from Imtec Corp.

28 FDA decisions under this applicant name. See the company

  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 20081 recall
  • K081347Iluma VisionImtec Corp. · 20081 recall
  • K072660Endure Implant, Model 5108, 5111, 5113, 5114Imtec Corp. · 2007
  • K053046Iluma Orthocat/DentalcatImtec Corp. · 2005
  • K043226Endure Implant, Models 3508, 4308, 3520, 4320Imtec Corp. · 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/K030243 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030243: Endure Implant, Model 3508,3511,3514,4308,4311,4314.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030243

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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