510(k) Report

510(k) · Cleared

Cleared

Atlantis Abutment and Atlantis Abutment Screw

K981858510(k) TraditionalCleared Mar 22, 1999299-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

Atlantis Components, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 22, 1999 as substantially equivalent to K931468 (Lifecore Biomedical, Inc., 1994) and 1 other predicate after a 299-day review. Its family tree reaches back 1 generation to 1994. 505 later devices descend from it.

Decided
Mar 22, 1999
Review
299 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K931468 (1994). 2 ancestors in all. 505 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2005: 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 clearedK931468 · Restore Hex Cylinder Endosseous System · Lifecore Biomedical, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 10 descendants2 generations forward: 28 descendants3 generations forward: 41 descendants4 generations forward: 61 descendants5 generations forward: 93 descendants6 generations forward: 117 descendants7 generations forward: 71 descendants8 generations forward: 45 descendants9 generations forward: 18 descendants10 generations forward: 8 descendants11 generations forward: 7 descendants12 generations forward: 5 descendants13 generations forward: 1 descendant K931468 · Restore Hex Cylinder Endosseous System · Lifecore Biomedical, Inc. · 19940+5+10
  1. Root · 1 generation backK931468 Restore Hex Cylinder Endosseous SystemLifecore Biomedical, Inc. · 1994
  2. This deviceK981858 Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc. · 1999
  3. Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  5. Descendant · cites it directly · 361 of its ownK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007
  6. Descendant · 2 generations on · 357 of its ownK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
  7. Descendant · 3 generations on · 337 of its ownK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008

Showing 5 of 505 descendants. See all descendants

Descendants cleared per year

2004: 32005: 62006: 82007: 92008: 52009: 112010: 102011: 182012: 142013: 132014: 202015: 262016: 292017: 232018: 222019: 212020: 392021: 312022: 332023: 422024: 562025: 422026: 24
2004high 56 (2024) · low 3 (2004)2026

Most influential descendants

Showing 5 of 505 · See all
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
  • K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007 · cites it directly361descendants
  • K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007 · 2 generations on357descendants
  • K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc. · 2008 · 3 generations on337descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931468Restore Hex Cylinder Endosseous SystemLifecore Biomedical, Inc.1994—
0 (this device)K981858Atlantis Abutment and Atlantis Abutment ScrewAtlantis Components, Inc.1999—
+1K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+2K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+1K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007—
+2K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc.2007—
+3K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0…Astra Tech, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K981858, 1994–2026Source: 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), 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? (2)

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
*K931468Restore Hex Cylinder Endosseous System
Summary page 1
…omedical RD Hexed UCLA Abutment Gold Sleeve and Lifecore Biomedical RD Titanium UCLA Abutment Screw With .048 in Hex. (These are covered in one or more of the following: K931468, K944069.) The Atlantis abutment is an abutment used with an endosseous implant that is implanted in the upper or lower jawbone.…
Lifecore Biomedical, Inc.1994—
*K944069Restore TPS Lhex Cylinder Endosseous Implant System
Summary page 1
…RD Hexed UCLA Abutment Gold Sleeve and Lifecore Biomedical RD Titanium UCLA Abutment Screw With .048 in Hex. (These are covered in one or more of the following: K931468, K944069.) The Atlantis abutment is an abutment used with an endosseous implant that is implanted in the upper or lower jawbone. The abut…
Lifecore Biomedical, Inc.1995—

What descends from it? (505)

See all 505

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

NumberDeviceApplicantDecidedDescendants
K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.2004476
K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007361
K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671
K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738
K051652Atlantis Abutment, Atlantis Gemini Abutment, Atlantis Gemini+ AbutmentAtlantis Components, Inc.200519
K053373Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.200613
K053654Atlantis Abutment for Nobel Replace InterfaceAtlantis Components, Inc.200612
K050052Atlantis Abutment for Straumann InterfaceAtlantis Components, Inc.20055
K051011Endosseous Dental Implant AbutmentAtlantis Components, Inc.20051
K062197Atlantis Abutment for 3I Certain Micro Mini; Gemini and Gemini+ AbutmentAtlantis Components, Inc.20070

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K032263 (Implant Innovations, Inc., 2004) has gone furthest, with 476 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—

What is it indicated for?

The Atlantis Abutment is used to connect an implanted fixture to a restoration.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Atlantis Components, Inc.

18 FDA decisions under this applicant name. See the company

  • K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc. · 2011
  • K073540Atlantis Abutment in Zirconia for Biohorizons ImplantAtlantis Components, Inc. · 2008
  • K073258Atlantis Abutment for Biohorizon Implants, Atlantis Gemini Abutment for Biohorizon Implants, Atlantis Gemini…Atlantis Components, Inc. · 2008
  • K072483Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in Zirconia for Astra…Atlantis Components, Inc. · 2007
  • K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc. · 2007

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/K981858 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981858: Atlantis Abutment and Atlantis Abutment Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981858

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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