510(k) Report

510(k) · Cleared

Cleared

Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite

K023952510(k) TraditionalCleared Jan 16, 200350-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 Jan 16, 2003 after a 50-day review. The FDA summary names no predicate by number. 295 later devices descend from it.

Decided
Jan 16, 2003
Review
50 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

295 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2008: 6 descendants cleared2003: 1 descendant cleared2007: 6 descendants cleared2005: 3 descendants cleared2014: 17 descendants cleared2004: 1 descendant cleared2009: 3 descendants cleared2011: 6 descendants cleared2012: 10 descendants cleared2018: 12 descendants cleared2010: 3 descendants cleared2016: 11 descendants cleared2013: 9 descendants cleared2006: 2 descendants cleared2017: 9 descendants cleared2015: 11 descendants cleared2021: 15 descendants cleared2022: 26 descendants cleared2025: 27 descendants cleared2020: 22 descendants cleared2019: 19 descendants cleared2023: 27 descendants cleared2024: 32 descendants cleared2026: 17 descendants cleared200020052010201520202025
  1. This deviceK023952 Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc. · 2003
  2. Descendant · cites it directly · 188 of its ownK041876 Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004
  3. Descendant · 2 generations on · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
  4. Descendant · 3 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
  5. Descendant · 4 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  6. Descendant · 5 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014

Showing 5 of 295 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 32006: 22007: 62008: 62009: 32010: 32011: 62012: 102013: 92014: 172015: 112016: 112017: 92018: 122019: 192020: 222021: 152022: 262023: 272024: 322025: 272026: 17
2003high 32 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 295 · See all
  • K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004 · cites it directly188descendants
  • K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · 2 generations on187descendants
  • K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 3 generations on141descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 4 generations on127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 5 generations on123descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023952Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteNobel Biocare Uas, Inc.2003—
+1K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc.2004—
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007—
+3K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200530
200620
200760
200860
200930
201030
201160
2012100
201390
2014170
2015110
2016110
201790
2018120
2019190
2020220
2021150
2022260
2023270
2024320
2025270
2026170
FIG. 1 — Lineage of K023952, 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?

The FDA summary names no predicate by number.

What descends from it? (295)

See all 295

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

NumberDeviceApplicantDecidedDescendants
K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc.2004188
K031345Nobel Direct, Models 30937, 30938Nobel Biocare Uas, Inc.200394
K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543
K061971Zirconia ImplantNobel Biocare AB200730
K133050One Plus Implant SystemOsseofuse, Inc.20141
K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080

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, K041876 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 188 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 Replace@One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing hnction.

Indications for use as stated in the FDA summary.

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/K023952 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023952: Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023952

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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