510(k) Report

510(k) · Cleared

Cleared

Restore Self Tapping Dental Implant System (3.4MM)

K951111510(k) TraditionalCleared Mar 31, 199521-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

Lifecore Biomedical, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 31, 1995 after a 21-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 80 later devices descend from it.

Decided
Mar 31, 1995
Review
21 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

80 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 3 descendants cleared2002: 1 descendant cleared2006: 4 descendants cleared2004: 1 descendant cleared2017: 4 descendants cleared2007: 6 descendants cleared2016: 4 descendants cleared2014: 5 descendants cleared2008: 4 descendants cleared2011: 4 descendants cleared2013: 5 descendants cleared2010: 1 descendant cleared2018: 6 descendants cleared2012: 3 descendants cleared2019: 1 descendant cleared2020: 5 descendants cleared2023: 6 descendants cleared2022: 4 descendants cleared2024: 5 descendants cleared2021: 3 descendants cleared2015: 3 descendants cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951111 Restore Self Tapping Dental Implant System (3.4MM)Lifecore Biomedical, Inc. · 1995
  2. Descendant · cites it directly · 43 of its ownK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
  3. Descendant · cites it directly · 40 of its ownK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
  4. Descendant · cites it directly · 36 of its ownK020617 Nsi Hexed and Non-Hexed Implant SystemNsi · 2002
  5. Descendant · 2 generations on · 32 of its ownK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
  6. Descendant · 2 generations on · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 32006: 42007: 62008: 42010: 12011: 42012: 32013: 52014: 52015: 32016: 42017: 42018: 62019: 12020: 52021: 32022: 42023: 62024: 52025: 12026: 1
2002high 6 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 80 · See all
  • K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005 · cites it directly43descendants
  • K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc. · 2005 · cites it directly40descendants
  • K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 2002 · cites it directly36descendants
  • K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004 · 2 generations on32descendants
  • K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951111Restore Self Tapping Dental Implant System (3.4MM)Lifecore Biomedical, Inc.1995—
+1K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.2005—
+1K051614Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc.20055
+1K020617Nsi Hexed and Non-Hexed Implant SystemNsi2002—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC2004—
+2K052490Endosseous Dental Implant SystemNorthern Implants, LLC2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200530
200640
200760
200840
201010
201140
201230
201350
201450
201530
201640
201740
201860
201910
202050
202130
202240
202360
202450
202510
202610
FIG. 1 — Lineage of K951111, 1995–2026Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543
K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc.200540
K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236

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, K050506 (Lifecore Biomedical, Inc., 2005) has gone furthest, with 43 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—

More from Lifecore Biomedical, Inc.

37 FDA decisions under this applicant name. See the company

  • K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007
  • K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc. · 2007
  • K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc. · 20072 recalls
  • K072572Primaconnex RD and WD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc. · 2007
  • K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc. · 2006

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/K951111 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951111: Restore Self Tapping Dental Implant System (3.4MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951111

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026