510(k) Report

510(k) · Cleared

Cleared

Restore TPS Lhex Cylinder Endosseous Implant System

K944069510(k) TraditionalCleared Feb 28, 1995194-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 28, 1995 after a 194-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 506 later devices descend from it.

Decided
Feb 28, 1995
Review
194 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

506 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2005: 6 descendants cleared2007: 9 descendants cleared2006: 8 descendants cleared2004: 3 descendants cleared2011: 18 descendants cleared2014: 20 descendants cleared2010: 10 descendants cleared2009: 11 descendants cleared2013: 13 descendants cleared2008: 5 descendants cleared2016: 29 descendants cleared2015: 26 descendants cleared2017: 23 descendants cleared2012: 14 descendants cleared2020: 39 descendants cleared2018: 22 descendants cleared2023: 42 descendants cleared2024: 56 descendants cleared2021: 31 descendants cleared2019: 21 descendants cleared2025: 42 descendants cleared2022: 33 descendants cleared2026: 24 descendants cleared1995200020052010201520202025
  1. This deviceK944069 Restore TPS Lhex Cylinder Endosseous Implant SystemLifecore Biomedical, Inc. · 1995
  2. Descendant · cites it directly · 505 of its ownK981858 Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc. · 1999
  3. Descendant · 2 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  4. Descendant · 3 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  5. Descendant · 2 generations on · 361 of its ownK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
  6. Descendant · 3 generations on · 357 of its ownK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007

Showing 5 of 506 descendants. See all descendants

Descendants cleared per year

1999: 12004: 32005: 62006: 82007: 92008: 52009: 112010: 102011: 182012: 142013: 132014: 202015: 262016: 292017: 232018: 222019: 212020: 392021: 312022: 332023: 422024: 562025: 422026: 24
1999high 56 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 506 · See all
  • K981858Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc. · 1999 · cites it directly505descendants
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 2 generations on476descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 3 generations on441descendants
  • K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007 · 2 generations on361descendants
  • K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007 · 3 generations on357descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944069Restore TPS Lhex Cylinder Endosseous Implant SystemLifecore Biomedical, Inc.1995—
+1K981858Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc.1999—
+2K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+3K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+2K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007—
+3K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200430
200560
200680
200790
200850
2009110
2010100
2011180
2012140
2013130
2014200
2015260
2016290
2017230
2018220
2019210
2020390
2021310
2022330
2023420
2024560
2025420
2026240
FIG. 1 — Lineage of K944069, 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? (506)

See all 506

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981858Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc.1999505

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, K981858 (Atlantis Components, Inc., 1999) has gone furthest, with 505 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/K944069 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944069: Restore TPS Lhex Cylinder Endosseous 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/K944069

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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