510(k) Report

510(k) · Cleared

Cleared

Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations

K965077510(k) TraditionalCleared Mar 17, 199790-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

Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 17, 1997 after a 90-day review. The FDA summary names its predicate without a number. 674 later devices descend from it.

Decided
Mar 17, 1997
Review
90 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 6 descendants cleared2002: 1 descendant cleared2000: 1 descendant cleared2003: 1 descendant cleared2006: 8 descendants cleared2007: 14 descendants cleared2010: 11 descendants cleared2011: 20 descendants cleared2014: 30 descendants cleared2005: 7 descendants cleared2018: 34 descendants cleared2009: 16 descendants cleared2017: 32 descendants cleared2012: 21 descendants cleared2019: 31 descendants cleared2015: 34 descendants cleared2008: 13 descendants cleared2013: 27 descendants cleared2016: 38 descendants cleared2021: 45 descendants cleared2023: 49 descendants cleared2020: 48 descendants cleared2024: 62 descendants cleared2022: 46 descendants cleared2026: 29 descendants cleared2025: 50 descendants cleared1995200020052010201520202025
  1. This deviceK965077 Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth…Implant Innovations, Inc. · 1997
  2. Descendant · cites it directly · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 463 of its ownK022113 3I Dental Implant AccessoriesImplant Innovations, Inc. · 2002
  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 · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  6. Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003

Showing 5 of 674 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12003: 12004: 62005: 72006: 82007: 142008: 132009: 162010: 112011: 202012: 212013: 272014: 302015: 342016: 382017: 322018: 342019: 312020: 482021: 452022: 462023: 492024: 622025: 502026: 29
2000high 62 (2024) · low 0 (2001)2026

Most influential descendants

Showing 5 of 674 · See all
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · cites it directly476descendants
  • K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002 · cites it directly463descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 2 generations on441descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
  • K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K965077Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement…Implant Innovations, Inc.1997—
+1K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+1K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002—
+2K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+2K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+2K0306143I Dental ImplantsImplant Innovations, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200310
200460
200570
200680
2007140
2008130
2009160
2010110
2011200
2012210
2013270
2014300
2015340
2016380
2017320
2018340
2019310
2020480
2021450
2022460
2023490
2024620
2025500
2026290
FIG. 1 — Lineage of K965077, 1997–2026Source: 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? (5)

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
*—3i Standard Abutment systems
Named without a submission number
—
*—3i Tapered Abutment systems
Named without a submission number
—
*—3i Conical Abutment systems
Named without a submission number
—
*—3i Abutment Posts
Named without a submission number
—
*—Nobel Bio-Care “Cera-One” abutment systems
Named without a submission number
—

What descends from it? (674)

See all 674

4 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
K0221133I Dental Implant AccessoriesImplant Innovations, Inc.2002463
K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491
K993894Lifecore Single Tooth Abutment SystemLifecore Biomedical, Inc.20000

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, 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 -:STA abutment system is indicated for use on pruperly placed and healed dental implants, to extend the coronal aspect of the implant through soft gingival tissues into the oral cavity to provide the attachment mechaniem for cement retained, single tooth restorations to restore a patient's chewing function.

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

More from Implant Innovations, Inc.

51 FDA decisions under this applicant name. See the company

  • K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental ImplantsImplant Innovations, Inc. · 2007
  • K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 200710 recalls
  • K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 20075 recalls
  • K063403Conical Angled AbutmentImplant Innovations, Inc. · 20075 recalls
  • K061629Certain Prevail Dental ImplantImplant Innovations, 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/K965077 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965077: Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965077

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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