510(k) Report

510(k) · Cleared

Recalled · 2010

Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX

K031106510(k) TraditionalCleared Aug 12, 2003126-day reviewClass II21 CFR 872.3640Recalls 1

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 Aug 12, 2003 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 227 later devices descend from it. It has been recalled once.

Decided
Aug 12, 2003
Review
126 days
Class
Class II
Product code
DZE
Recalls
1
Predicates
0

227 later devices descend from it, 23 citing it directly.

Descendants, by year cleared 2017: 7 descendants cleared2009: 7 descendants cleared2010: 4 descendants cleared2012: 8 descendants cleared2019: 15 descendants cleared2008: 5 descendants cleared2007: 3 descendants cleared2014: 10 descendants cleared2016: 7 descendants cleared2013: 7 descendants cleared2015: 8 descendants cleared2011: 2 descendants cleared2021: 16 descendants cleared2018: 9 descendants cleared2020: 18 descendants cleared2022: 20 descendants cleared2024: 21 descendants cleared2025: 26 descendants cleared2023: 20 descendants cleared2026: 14 descendants cleared200020052010201520202025
  1. This deviceK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003
  2. Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
  3. Descendant · cites it directly · 144 of its ownK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
  4. Descendant · cites it directly · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
  5. Descendant · 2 generations on · 135 of its ownK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  6. Descendant · 3 generations on · 134 of its ownK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009

Showing 5 of 227 descendants. See all descendants

Descendants cleared per year

2007: 32008: 52009: 72010: 42011: 22012: 82013: 72014: 102015: 82016: 72017: 72018: 92019: 152020: 182021: 162022: 202023: 202024: 212025: 262026: 14
2007high 26 (2025) · low 2 (2011)2026

Most influential descendants

Showing 5 of 227 · See all
  • K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
  • K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007 · cites it directly144descendants
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · cites it directly141descendants
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008 · 2 generations on135descendants
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009 · 3 generations on134descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22…Imtec Corp.2003—
+1K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007—
+1K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007—
+1K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081
+2K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008—
+3K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200850
200970
201040
201120
201280
201370
2014100
201580
201670
201770
201890
2019150
2020180
2021160
2022200
2023200
2024210
2025260
2026140
FIG. 1 — Lineage of K031106, 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? (227)

See all 227

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

NumberDeviceApplicantDecidedDescendants
K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187
K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007144
K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.2008141
K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425
K100932Inclusive Mini ImplantPrismatik Dentalcraft, Inc.201015
K083544Kat Implant SystemKat Implants, LLC20094
K191895Straumann Mini ImplantsInstitut Straumann AG20193
K083886Simpler Mini Implant, Models SM 5002, SM 5003, SM 5004Simpler One Stop20092
K162867MagDen Dental Implant SystemShinhung Mst Co., Ltd.20171
K131701Z5MLB, Z5MLCZ-Systems AG20131

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 14, 2010Not classifiedZ-1703-2010Packaging process controlProduct has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K063364 (Alpha-Bio Tec, Ltd., 2007) has gone furthest, with 187 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?

The MDI and MDI PLUS are self-tapping titanium threaded screws indicated for long-term intra-bony applications.

Additionally, the MDI may also be used for inter-radicular transitional applications.

These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention.

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/K031106 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031106

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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