510(k) Report

510(k) · Cleared

Cleared

OBI

K083669510(k) TraditionalCleared Jun 8, 2009179-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

Euroteknika · DZE Implant, Endosseous, Root-Form

Cleared on Jun 8, 2009 as substantially equivalent to K050970 (Intra-Lock International, 2005) and 3 other predicates after a 179-day review. Its family tree reaches back 10 generations to 1996.

Decided
Jun 8, 2009
Review
179 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 10 generations to K960026 (1996). 26 ancestors in all, the oldest K925765 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2001: 2 other ancestors1997: 1 other ancestor2004: 1 other ancestor2003: 4 other ancestors2002: 2 other ancestors2000: 1 other ancestor1999: 3 other ancestors1993: 1 other ancestorK960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997×2: 2 generations cleared close together, K020133 (2002), K020645 (2002) K022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK032351 · The Maestro System 3.0MM Diameter Implant · BioHorizons Implant Systems, Inc. · 2003K041938 · Maximus OS (Overdenture System) · BioHorizons Implant Systems, Inc. · 2004 · recalledK050970 · Milo Dental Implant System · Intra-Lock International · 200519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 3 other ancestors4 generations back: 4 other ancestors5 generations back: 1 other ancestor K050970 · Milo Dental Implant System · Intra-Lock International · 2005K041938 · Maximus OS (Overdenture System) · BioHorizons Implant Systems, Inc. · 2004 · recalledK032351 · The Maestro System 3.0MM Diameter Implant · BioHorizons Implant Systems, Inc. · 2003K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020645 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020133 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996−10−50
  1. Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 6 generations between
  3. 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  4. 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
  5. 1 generation backK050970 Milo Dental Implant SystemIntra-Lock International · 2005
  6. This deviceK083669 OBIEuroteknika · 2009
Show all 10 generations
  1. Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
  3. 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
  4. 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  5. 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  6. 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  7. 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
  8. 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
  9. 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
  10. 1 generation backK050970 Milo Dental Implant SystemIntra-Lock International · 2005
  11. This deviceK083669 OBIEuroteknika · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K960026Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc.1996—
−9K964330Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc.1997—
−8K972313The Maestro SystemBioHorizons Implant Systems, Inc.1997—
−7K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−6K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−5K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−4K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc.20031
−3K032351The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc.2003—
−2K041938Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc.20042
−1K050970Milo Dental Implant SystemIntra-Lock International2005—
0 (this device)K083669OBIEuroteknika2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
199930
200010
200120
200220
200340
200410
200710
FIG. 1 — Lineage of K083669, 1996–2009Source: 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 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? (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
*K050970Milo Dental Implant System
Summary page 1
…ntra-Lock Mini Dental Implant Sulzer Medica) Swiss MDL Milo (MDI) Plus Conical (K 070601) (K 050970) (K 972351) (K 011245) 6. Devices Description: A set of root form endosseous dental implants and…
Intra-Lock International2005—
*K972351Sendax Mdi (Mini Dental Implant)
Summary page 1
…Dental Implant Sulzer Medica) Swiss MDL Milo (MDI) Plus Conical (K 070601) (K 050970) (K 972351) (K 011245) 6. Devices Description: A set of root form endosseous dental implants and components for surgi…
Sendax Mdic Management, Inc.1997—
*K011245Advent Implant System, Swiss Plus Implant System
Summary page 1
…Medica) Swiss MDL Milo (MDI) Plus Conical (K 070601) (K 050970) (K 972351) (K 011245) 6. Devices Description: A set of root form endosseous dental implants and components for surgical placement in maxillar…
Sulzer Dental, Inc.2001—
*K070601Mini Drive-Lock Dental Implant System
Summary page 1
…ntra-Lock Intra-Lock Mini Dental Implant Sulzer Medica) Swiss MDL Milo (MDI) Plus Conical (K 070601) (K 050970) (K 972351) (K 011245) 6. Devices Description: A set of root form endosseous den…
Intra-Lock International2007—

Also cleared against K050970: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • 3 of the 26 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K050970.

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. 2009, this device’s year, is highlighted.

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?

Surgical placement in mandibular arch to support overdentures in edentulous patients.

Indications for use as stated in the FDA summary.

Also cleared against K050970

4 other devices cite the same predicate.

  • K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
  • K131701Z5MLB, Z5MLCZ-Systems AG · 2013
  • K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013
  • K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012

More from Euroteknika

3 FDA decisions under this applicant name. See the company

  • K232383iPhysio® SystemEuroteknika · 2025
  • K083670Universal, Aesthetica, Natea, NaturaEuroteknika · 2009

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/K083669 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083669: OBI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083669

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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