510(k) Report

510(k) · Cleared

Cleared

Endosseous Dental Implant

K113113510(k) TraditionalCleared Nov 16, 2012393-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

Ot Medical GmbH · DZE Implant, Endosseous, Root-Form

Cleared on Nov 16, 2012 as substantially equivalent to K053242 (Innova Life Sciences Corp., 2006) and 3 other predicates after a 393-day review. Its family tree reaches back 3 generations to 1991.

Decided
Nov 16, 2012
Review
393 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K902435 (1991). 22 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1999: 1 other ancestor1994: 8 other ancestors1993: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1984: 1 other ancestor1982: 1 other ancestorK902435 · Dia Impression Coping · Dental Imaging Assoc., Inc. · 1991K961385 · MT-3A · The Emerging Technologies Group · 1996K053242 · Pitt-Easy Dental Implant System · Innova Life Sciences Corp. · 20061980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 15 other ancestors K053242 · Pitt-Easy Dental Implant System · Innova Life Sciences Corp. · 2006K961385 · MT-3A · The Emerging Technologies Group · 1996K902435 · Dia Impression Coping · Dental Imaging Assoc., Inc. · 19910
  1. Root · 3 generations backK902435 Dia Impression CopingDental Imaging Assoc., Inc. · 1991
  2. 2 generations backK961385 MT-3AThe Emerging Technologies Group · 1996
  3. 1 generation backK053242 Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006
  4. This deviceK113113 Endosseous Dental ImplantOt Medical GmbH · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K902435Dia Impression CopingDental Imaging Assoc., Inc.1991—
−2K961385MT-3AThe Emerging Technologies Group1996—
−1K053242Pitt-Easy Dental Implant SystemInnova Life Sciences Corp.2006—
0 (this device)K113113Endosseous Dental ImplantOt Medical GmbH2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198410
199110
199210
199320
199480
199510
199720
199910
200310
FIG. 1 — Lineage of K113113, 1991–2012Source: 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 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
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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
*K053242Pitt-Easy Dental Implant System
Summary page 1
…eous Dental Implant system Purpose: The purpose of this 510(k) isto obtain clearance for sale in the U.S.A. for theOT-F2 Dental Implant System. predicate Devices: K053242 Pitt-Easy Dental Implant System Device Description: The CT-F' implants are available in the diameters 3.8, 4.1 and 5.0mm. For th…
Innova Life Sciences Corp.2006—
*K926354Endo-Pore Endosseous Dental Implant System
Summary page 4
…ous Dental Implant System Purpose: The purpose of this 510(k) isto obtain clearance for sale in the U.S.A. for the OT-F3 Dental Implant System. Predicate Devices: K926354 Endopore Dental Implant System (Innova) K971196 Endopore Dental Implant System (Innova)…
Innova Corp.1995—
*K971196Endopore Endosseous Dental Implant System
Summary page 4
…in clearance for sale in the U.S.A. for the OT-F3 Dental Implant System. Predicate Devices: K926354 Endopore Dental Implant System (Innova) K971196 Endopore Dental Implant System (Innova) K032140 Endopore Dental Implant System (Innova) Device Descripti…
Innova Corp.1997—
*K0321405.0 X 5MM Endopore Endosseous Dental Implant System
Summary page 4
…Predicate Devices: K926354 Endopore Dental Implant System (Innova) K971196 Endopore Dental Implant System (Innova) K032140 Endopore Dental Implant System (Innova) Device Description: The OT-F 3 implants are available in the diameters 4.1 and 5.0mm. Fo…
Innova Life Sciences Corp.2003—

Also cleared against K053242: 1 other device →

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 21 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
  • 1 of the 22 ancestors has a recall of any class.
  • 1 other device also cites its predicate K053242.

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. 2012, 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?

The OT-F73 Implant System is intended to be implanted in the upper or lower jaw arches to provide support far fixed or removable dental prostheses In a single tooth, partially edlentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

Indications for use as stated in the FDA summary.

Also cleared against K053242

1 other device cites the same predicate.

  • K083297Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009

More from Ot Medical GmbH

3 FDA decisions under this applicant name. See the company

  • K1516084plus6Line Abutment SystemOt Medical GmbH · 2016
  • K151432NaturalLine AbutmentOt Medical GmbH · 2015

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/K113113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113113: Endosseous Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113113

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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