510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

One and Two Piece Temporary Healing,(Emergence Profile) Abutments

K934126510(k) TraditionalCleared Apr 25, 1994243-day reviewClass II21 CFR 872.3640Recalls 7

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 Apr 25, 1994 after a 243-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 620 later devices descend from it. It has been recalled 7 times.

Decided
Apr 25, 1994
Review
243 days
Class
Class II
Product code
DZE
Recalls
7
Predicates
0

620 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 1996: 9 descendants cleared2003: 1 descendant cleared2004: 5 descendants cleared1998: 1 descendant cleared2007: 11 descendants cleared2005: 6 descendants cleared2011: 20 descendants cleared2014: 26 descendants cleared2010: 10 descendants cleared2006: 8 descendants cleared2008: 10 descendants cleared2009: 16 descendants cleared2013: 22 descendants cleared2015: 30 descendants cleared2016: 37 descendants cleared2012: 17 descendants cleared2017: 28 descendants cleared2023: 47 descendants cleared2018: 27 descendants cleared2020: 43 descendants cleared2024: 62 descendants cleared2021: 40 descendants cleared2022: 42 descendants cleared2025: 47 descendants cleared2026: 28 descendants cleared2019: 27 descendants cleared1990200020102020
  1. This deviceK934126 One and Two Piece Temporary Healing,(Emergence Profile) AbutmentsImplant Innovations, Inc. · 1994
  2. Descendant · cites it directly · 477 of its ownK980083 3I Orthodontic Abutment, OrthobutmentImplant Innovations, Inc. · 1998
  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 · 2 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
  6. Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003

Showing 5 of 620 descendants. See all descendants

Descendants cleared per year

1996: 91998: 12003: 12004: 52005: 62006: 82007: 112008: 102009: 162010: 102011: 202012: 172013: 222014: 262015: 302016: 372017: 282018: 272019: 272020: 432021: 402022: 422023: 472024: 622025: 472026: 28
1996high 62 (2024) · low 0 (1997)2026

Most influential descendants

Showing 5 of 620 · See all
  • K9800833I Orthodontic Abutment, OrthobutmentImplant Innovations, Inc. · 1998 · cites it directly477descendants
  • 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
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 2 generations on327descendants
  • K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · cites it directly319descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934126One and Two Piece Temporary Healing,(Emergence Profile) AbutmentsImplant Innovations, Inc.1994—
+1K9800833I Orthodontic Abutment, OrthobutmentImplant Innovations, Inc.1998—
+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—
+2K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—
+1K0306143I Dental ImplantsImplant Innovations, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199690
199810
200310
200450
200560
200680
2007110
2008100
2009160
2010100
2011200
2012170
2013220
2014260
2015300
2016370
2017280
2018270
2019270
2020430
2021400
2022420
2023470
2024620
2025470
2026280
FIG. 1 — Lineage of K934126, 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (620)

See all 620

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

NumberDeviceApplicantDecidedDescendants
K9800833I Orthodontic Abutment, OrthobutmentImplant Innovations, Inc.1998477
K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.2004476
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491
K961385MT-3AThe Emerging Technologies Group199687
K961387MT-XThe Emerging Technologies Group19960
K961382MT1AThe Emerging Technologies Group19960
K961384MT-2The Emerging Technologies Group19960
K961383MT1The Emerging Technologies Group19960
K961386MT-2AThe Emerging Technologies Group19960

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2015Class IIZ-2441-2016PackagingPouches may not have been sealed during packing.
Sep 21, 2015Class IIZ-0592-2016Process controlInadequate biocompatibility testing.
Sep 21, 2015Class IIZ-0591-2016Process controlInadequate biocompatibility testing.
Feb 23, 2010Not classifiedZ-2799-2011Error in labelingBiomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.
Apr 25, 2007Not classifiedZ-0811-2007OtherThe Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
Oct 16, 2006Not classifiedZ-0922-2007OtherPackage Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
Oct 4, 2004Not classifiedZ-0029-05OtherThe nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K980083 (Implant Innovations, Inc., 1998) has gone furthest, with 477 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 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/K934126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934126

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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