510(k) Report

510(k) · Cleared

Cleared

Nobel Direct, Models 30937, 30938

K031345510(k) TraditionalCleared Jul 24, 200386-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

Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jul 24, 2003 as substantially equivalent to K023952 (Nobel Biocare Uas, Inc., 2003) after an 86-day review. Its family tree reaches back 1 generation to 2003. 94 later devices descend from it.

Decided
Jul 24, 2003
Review
86 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K023952 (2003). 94 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2005: 3 descendants cleared2014: 7 descendants cleared2007: 4 descendants cleared2012: 5 descendants cleared2013: 5 descendants cleared2016: 3 descendants cleared2008: 3 descendants cleared2006: 2 descendants cleared2011: 4 descendants cleared2010: 1 descendant cleared2023: 11 descendants cleared2019: 2 descendants cleared2020: 5 descendants cleared2024: 12 descendants cleared2022: 6 descendants cleared2017: 3 descendants cleared2018: 2 descendants cleared2026: 5 descendants cleared2015: 3 descendants cleared2025: 4 descendants cleared2021: 1 descendant clearedK023952 · Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite · Nobel Biocare Uas, Inc. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 16 descendants4 generations forward: 29 descendants5 generations forward: 29 descendants6 generations forward: 6 descendants K023952 · Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite · Nobel Biocare Uas, Inc. · 20030+5
  1. Root · 1 generation backK023952 Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc. · 2003
  2. This deviceK031345 Nobel Direct, Models 30937, 30938Nobel Biocare Uas, Inc. · 2003
  3. Descendant · cites it directly · 43 of its ownK070857 Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB · 2007
  4. Descendant · cites it directly · 43 of its ownK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
  5. Descendant · 2 generations on · 42 of its ownK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
  6. Descendant · 2 generations on · 40 of its ownK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
  7. Descendant · 3 generations on · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

2005: 32006: 22007: 42008: 32009: 32010: 12011: 42012: 52013: 52014: 72015: 32016: 32017: 32018: 22019: 22020: 52021: 12022: 62023: 112024: 122025: 42026: 5
2005high 12 (2024) · low 1 (2010)2026

Most influential descendants

Showing 5 of 94 · See all
  • K070857Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB · 2007 · cites it directly43descendants
  • K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005 · cites it directly43descendants
  • K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008 · 2 generations on42descendants
  • K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc. · 2005 · 2 generations on40descendants
  • K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K023952Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc.2003—
0 (this device)K031345Nobel Direct, Models 30937, 30938Nobel Biocare Uas, Inc.2003—
+1K070857Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB2007—
+1K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.2005—
+2K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd.2008—
+2K051614Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc.20055
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200620
200740
200830
200930
201010
201140
201250
201350
201470
201530
201630
201730
201820
201920
202050
202110
202260
2023110
2024120
202540
202650
FIG. 1 — Lineage of K031345, 2003–2026Source: 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? (1)

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
*K023952Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite
Summary page 1
…al Implant (21 CFR 872.3640) Trade or Proprietary or Model Name: Nobel Direct Legally Marketed Device: Replace@One Piece Implant (K023952) (also known as > Nobel Direct) Device Description: Nobel Biocare’s Nobel Direct is a na…
Nobel Biocare Uas, Inc.2003—

Also cleared against K023952: 5 other devices →

What descends from it? (94)

See all 94

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

NumberDeviceApplicantDecidedDescendants
K070857Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB200743
K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543
K050970Milo Dental Implant SystemIntra-Lock International20057
K133706ZL Microdent Natural Lock Implant SystemZl Microdent-Attachment GmbH & Co. KG20140
K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090

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?

  • Its one ancestor has no recall.
  • Of its descendants, K070857 (Nobel Biocare AB, 2007) has gone furthest, with 43 descendants of its own.
  • 5 other devices also cite its predicate K023952.

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 Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisols to supporl prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Indications for use as stated in the FDA summary.

Also cleared against K023952

5 other devices cite the same predicate.

  • K133050One Plus Implant SystemOsseofuse, Inc. · 2014
  • K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
  • K061971Zirconia ImplantNobel Biocare AB · 2007
  • K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
  • K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004

More from Nobel Biocare Uas, Inc.

31 FDA decisions under this applicant name. See the company

  • K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  • K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004
  • K041312Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004

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/K031345 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031345: Nobel Direct, Models 30937, 30938.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031345

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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