510(k) Report

510(k) · Cleared

Cleared

Branemark-Healing Caps, DCC045, DCC046, DCC104

K934826510(k) TraditionalCleared Aug 8, 1994304-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

Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Aug 8, 1994 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 96 later devices descend from it.

Decided
Aug 8, 1994
Review
304 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

96 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 1996: 9 descendants cleared2006: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2011: 3 descendants cleared2017: 4 descendants cleared2013: 2 descendants cleared2021: 6 descendants cleared2014: 4 descendants cleared2016: 7 descendants cleared2019: 5 descendants cleared2015: 2 descendants cleared2023: 8 descendants cleared2018: 3 descendants cleared2024: 8 descendants cleared2020: 8 descendants cleared2022: 9 descendants cleared2025: 9 descendants cleared2026: 5 descendants cleared1990200020102020
  1. This deviceK934826 Branemark-Healing Caps, DCC045, DCC046, DCC104Nobelpharma USA, Inc. · 1994
  2. Descendant · cites it directly · 87 of its ownK961385 MT-3AThe Emerging Technologies Group · 1996
  3. Descendant · 2 generations on · 86 of its ownK053242 Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006
  4. Descendant · 3 generations on · 84 of its ownK083297 Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009
  5. Descendant · 4 generations on · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
  6. Descendant · 5 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

1996: 92006: 12009: 12011: 32012: 22013: 22014: 42015: 22016: 72017: 42018: 32019: 52020: 82021: 62022: 92023: 82024: 82025: 92026: 5
1996high 9 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 96 · See all
  • K961385MT-3AThe Emerging Technologies Group · 1996 · cites it directly87descendants
  • K053242Pitt-Easy Dental Implant SystemInnova Life Sciences Corp. · 2006 · 2 generations on86descendants
  • K083297Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH · 2009 · 3 generations on84descendants
  • K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · 4 generations on83descendants
  • K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 5 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934826Branemark-Healing Caps, DCC045, DCC046, DCC104Nobelpharma USA, Inc.1994—
+1K961385MT-3AThe Emerging Technologies Group1996—
+2K053242Pitt-Easy Dental Implant SystemInnova Life Sciences Corp.2006—
+3K083297Pitt-Easy Dental Implant SystemSybron Implant Solutions GmbH2009—
+4K102804Spi Titanium Base for Cad/CamThommen Medical AG2011—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199690
200610
200910
201130
201220
201320
201440
201520
201670
201740
201830
201950
202080
202160
202290
202380
202480
202590
202650
FIG. 1 — Lineage of K934826, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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? (96)

See all 96

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

NumberDeviceApplicantDecidedDescendants
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
K960111KIS MT4The Implant Center of the Palm Beaches19960
K960110KIS MT3The Implant Center of the Palm Beaches19960
K960112KIS MT5The Implant Center of the Palm Beaches19960

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, K961385 (The Emerging Technologies Group, 1996) has gone furthest, with 87 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 Nobelpharma USA, Inc.

64 FDA decisions under this applicant name. See the company

  • K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
  • K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  • K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
  • K962130Branemark Systems Mkii Selk-Tapping FixtureNobelpharma USA, Inc. · 1996
  • K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996

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/K934826 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934826: Branemark-Healing Caps, DCC045, DCC046, DCC104.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934826

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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