510(k) Report

510(k) · Cleared

Cleared

Restore Self Tapping Dental Implant System

K954512510(k) TraditionalCleared Feb 23, 1996148-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 Feb 23, 1996 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 702 later devices descend from it.

Decided
Feb 23, 1996
Review
148 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

702 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared2004: 4 descendants cleared2009: 14 descendants cleared2006: 10 descendants cleared2011: 15 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2001: 1 descendant cleared2014: 36 descendants cleared2012: 26 descendants cleared2015: 37 descendants cleared2013: 25 descendants cleared2010: 17 descendants cleared2007: 5 descendants cleared2023: 63 descendants cleared2016: 36 descendants cleared2024: 70 descendants cleared2018: 31 descendants cleared2021: 50 descendants cleared2017: 37 descendants cleared2019: 32 descendants cleared2020: 54 descendants cleared2025: 50 descendants cleared2022: 46 descendants cleared2026: 30 descendants cleared1995200020052010201520202025
  1. This deviceK954512 Restore Self Tapping Dental Implant SystemLifecore Biomedical, Inc. · 1996
  2. Descendant · cites it directly · 510 of its ownK983742 Iti Dental Implant SystemInstitut Straumann AG · 1999
  3. Descendant · cites it directly · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  4. Descendant · 2 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
  5. Descendant · 2 generations on · 346 of its ownK033922 Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · Recalled
  6. Descendant · cites it directly · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004

Showing 5 of 702 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12001: 12004: 42005: 32006: 102007: 52008: 82009: 142010: 172011: 152012: 262013: 252014: 362015: 372016: 362017: 372018: 312019: 322020: 542021: 502022: 462023: 632024: 702025: 502026: 30
1997high 70 (2024) · low 0 (1998)2026

Most influential descendants

Showing 5 of 702 · See all
  • K983742Iti Dental Implant SystemInstitut Straumann AG · 1999 · cites it directly510descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · cites it directly441descendants
  • K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
  • K033922Modification to Iti Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on346descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · cites it directly327descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954512Restore Self Tapping Dental Implant SystemLifecore Biomedical, Inc.1996—
+1K983742Iti Dental Implant SystemInstitut Straumann AG1999—
+1K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004—
+2K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20041
+1K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200110
200440
200530
2006100
200750
200880
2009140
2010170
2011150
2012260
2013250
2014360
2015370
2016360
2017370
2018310
2019320
2020540
2021500
2022460
2023630
2024700
2025500
2026300
FIG. 1 — Lineage of K954512, 1996–2026Source: 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? (702)

See all 702

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

NumberDeviceApplicantDecidedDescendants
K983742Iti Dental Implant SystemInstitut Straumann AG1999510
K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc.2004441
K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327
K965135Lifecore Conical AbutmentLifecore Biomedical, Inc.19970

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, K983742 (Institut Straumann AG, 1999) has gone furthest, with 510 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/K954512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954512: Restore Self Tapping Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954512

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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