510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

3I Patient-Specific Dental Abutment and Overdenture Bar

K032263510(k) TraditionalCleared Jan 28, 2004189-day reviewClass II21 CFR 872.3640Recalls 1

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 Jan 28, 2004 as substantially equivalent to K012911 (Implant Innovations, Inc., 2001) and 12 other predicates after a 189-day review. Its family tree reaches back 5 generations to 1995. 476 later devices descend from it. It has been recalled once.

Decided
Jan 28, 2004
Review
189 days
Class
Class II
Product code
DZE
Recalls
1
Predicates
13

Its longest line of descent runs back 5 generations to K944964 (1995). 34 ancestors in all, the oldest K871863 (1987). 476 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1994: 7 other ancestors1989: 1 other ancestor1987: 1 other ancestor1995: 4 other ancestors1993: 8 other ancestors1991: 1 other ancestor2011: 13 descendants cleared2014: 20 descendants cleared2005: 3 descendants cleared2010: 9 descendants cleared2004: 2 descendants cleared2009: 11 descendants cleared2006: 6 descendants cleared2008: 3 descendants cleared2007: 4 descendants cleared2013: 11 descendants cleared2017: 22 descendants cleared2015: 24 descendants cleared2023: 42 descendants cleared2012: 11 descendants cleared2020: 38 descendants cleared2016: 28 descendants cleared2024: 56 descendants cleared2021: 31 descendants cleared2018: 22 descendants cleared2025: 42 descendants cleared2019: 21 descendants cleared2022: 33 descendants cleared2026: 24 descendants clearedK944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 1995×2: 2 generations cleared close together, K961728 (1996), K962403 (1996) K971706 · Tiadapt Abutment System · Nobel Biocare Uas, Inc. · 1997K974150 · Procera Preparable Abutment System · Nobel Biocare Uas, Inc. · 1998 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 2 other ancestors3 generations back: 9 other ancestors4 generations back: 6 other ancestors 1 generation forward: 10 descendants2 generations forward: 20 descendants3 generations forward: 48 descendants4 generations forward: 79 descendants5 generations forward: 78 descendants6 generations forward: 72 descendants7 generations forward: 58 descendants8 generations forward: 45 descendants9 generations forward: 27 descendants10 generations forward: 25 descendants11 generations forward: 8 descendants12 generations forward: 4 descendants13 generations forward: 1 descendant14 generations forward: 1 descendant K974150 · Procera Preparable Abutment System · Nobel Biocare Uas, Inc. · 1998 · recalledK971706 · Tiadapt Abutment System · Nobel Biocare Uas, Inc. · 1997K962403 · Noblepharma Wide Accessories · Nobelpharma USA, Inc. · 1996K961728 · Miruscone Abutment System · Nobelpharma USA, Inc. · 1996K944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 1995−50+5+10
  1. Root · 5 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 4 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. 3 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. 2 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. 1 generation backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. This deviceK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004
  7. Descendant · cites it directly · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. Descendant · cites it directly · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  9. Descendant · 2 generations on · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
  10. Descendant · 2 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
  11. Descendant · 2 generations on · 261 of its ownK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005

Showing 5 of 476 descendants. See all descendants

Descendants cleared per year

2004: 22005: 32006: 62007: 42008: 32009: 112010: 92011: 132012: 112013: 112014: 202015: 242016: 282017: 222018: 222019: 212020: 382021: 312022: 332023: 422024: 562025: 422026: 24
2004high 56 (2024) · low 2 (2004)2026

Most influential descendants

Showing 5 of 476 · See all
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · cites it directly441descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · cites it directly327descendants
  • K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · 2 generations on313descendants
  • K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 2 generations on278descendants
  • K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Atlantis Components, Inc. · 2005 · 2 generations on261descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−4K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
−3K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
−2K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
−1K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
0 (this device)K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.2004—
+1K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+1K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+2K090069Procera Implant Bridge OverdentureNobel Biocare AB2009—
+2K091756Nobelprocera TI AbutmentNobel Biocare AB2009—
+2K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis…Atlantis Components, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199110
199380
199470
199540
199620
199710
199810
199920
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200530
200660
200740
200830
2009110
201090
2011130
2012110
2013110
2014200
2015240
2016280
2017220
2018220
2019210
2020380
2021310
2022330
2023420
2024560
2025420
2026240
FIG. 1 — Lineage of K032263, 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), 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? (13)

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
*K0129113I Locater Abutment System
Summary page 1
…the market in overall design and intended use. Predicate devices include: K012911 LOCATOR Anchor System K991947…
Implant Innovations, Inc.200111
*K9919473I Ceramic Abutment System
Summary page 1
…es include: K012911 LOCATOR Anchor System K991947 3i Ceramic Abutment System Implant Innovations, Inc. 510(k) Premarket N…
Implant Innovations, Inc.1999—
*K9800833I Orthodontic Abutment, Orthobutment
Summary page 2
…butment System Implant Innovations, Inc. 510(k) Premarket Notification - 3i Patient-Specific Dental Abutments K980083 3i Orthodontic Abutment Systems K965077…
Implant Innovations, Inc.1998—
*K965077Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained…
Summary page 2
…ts K980083 3i Orthodontic Abutment Systems K965077 3i Single Tooth Abutment System K962465…
Implant Innovations, Inc.1997—
*K962465TIL313 Abutment and Retaining Screw Systems
Summary page 2
…tems K965077 3i Single Tooth Abutment System K962465 3i Abutment & Retaining Screw System K932123…
Implant Innovations, Inc.1996—
*K932123Implant Innovation Pre-Angled Abutment System
Summary page 2
…K962465 3i Abutment & Retaining Screw System K932123 3i Pre-Angled Abutment System K933462…
Implant Innovations International, Inc.1994—
*K933462Conical Abutment
Summary page 2
…System K932123 3i Pre-Angled Abutment System K933462 3i Conical Abutment System K933969…
Implant Innovations, Inc.1994—
*K933969Tapered Abutment and Related Components
Summary page 2
…nt System K933462 3i Conical Abutment System K933969 3i Tapered Abutment System & Components K93412…
Implant Innovations, Inc.1994—
*K934126One and Two Piece Temporary Healing,(Emergence Profile) Abutments
Summary page 2
…K933969 3i Tapered Abutment System & Components K934126 3i One and Two Piece Temporary Healing Abutment…
Implant Innovations, Inc.19947
*K891613Overdenture Attachment
Summary page 2
…3i One and Two Piece Temporary Healing Abutments K891613 3i Overdenture Attachments K871863…
Implant Innovations International, Inc.19896
*K871863Adbutment Cylinder and Screw
Summary page 2
…Abutments K891613 3i Overdenture Attachments K871863 3i Dental Implant Abutment Systems K974150…
Implant Innovations International, Inc.1987—
*K974150Procera Preparable Abutment System
Summary page 2
…s K871863 3i Dental Implant Abutment Systems K974150 Nobel Biocare, Inc. Procera® Preparable Abutmen…
Nobel Biocare Uas, Inc.19982
*K981858Atlantis Abutment and Atlantis Abutment Screw
Summary page 2
…Nobel Biocare, Inc. Procera® Preparable Abutment System K981858 Atlantis Components, Inc. Atlantis Abutment and…
Atlantis Components, Inc.1999—

Also cleared against K012911: 2 other devices →

What descends from it? (476)

See all 476

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

NumberDeviceApplicantDecidedDescendants
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
K102804Spi Titanium Base for Cad/CamThommen Medical AG201183
K052648Modification to 3I Patient-Specific Dental Abutments and Overdenture BarsImplant Innovations, Inc.200517
K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412
K051501ZiraceAcucera, Inc.20058
K102209Encode Patient Specific AbutmentBiomet 3i, Inc.20101
K101608Biomet 3I Patient Specific Dental Abutments-Encode AbutmentsBiomet 3i, Inc.20110
K101607Biomet 3I Patient Specific Dental Abutments - Encode AbutmentsBiomet 3i, Inc.20110
K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 26, 2013Class IIZ-1215-2014Device DesignReports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 4 of the 34 ancestors have a recall of any class.
  • Of its descendants, K042658 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 441 descendants of its own.
  • 2 other devices also cite its predicate K012911.

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 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Indications for use as stated in the FDA summary.

Also cleared against K012911

2 other devices cite the same predicate.

  • K071838Neoss Various Titanium AbutmentsNeoss, Ltd. · 2007
  • K0221133I Dental Implant AccessoriesImplant Innovations, Inc. · 2002

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/K032263 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032263

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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