510(k) Report

510(k) · Cleared

Cleared

Endosseous Dental Implant

K971578510(k) TraditionalCleared Jun 30, 199761-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

Straumann USA · DZE Implant, Endosseous, Root-Form

Cleared on Jun 30, 1997 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,113 later devices descend from it.

Decided
Jun 30, 1997
Review
61 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

1,113 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1999: 3 descendants cleared2005: 21 descendants cleared1998: 1 descendant cleared2006: 31 descendants cleared2004: 16 descendants cleared2008: 42 descendants cleared2014: 48 descendants cleared2010: 29 descendants cleared2012: 41 descendants cleared2015: 50 descendants cleared2007: 28 descendants cleared2013: 56 descendants cleared2009: 34 descendants cleared2016: 55 descendants cleared2001: 2 descendants cleared2000: 2 descendants cleared2003: 8 descendants cleared2002: 6 descendants cleared2011: 43 descendants cleared2017: 51 descendants cleared2021: 59 descendants cleared2023: 75 descendants cleared2020: 76 descendants cleared2022: 61 descendants cleared2018: 50 descendants cleared2025: 67 descendants cleared2024: 80 descendants cleared2019: 44 descendants cleared2026: 34 descendants cleared1995200020052010201520202025
  1. This deviceK971578 Endosseous Dental ImplantStraumann USA · 1997
  2. Descendant · cites it directly · 1,043 of its ownK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. Descendant · 2 generations on · 942 of its ownK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
  4. Descendant · 2 generations on · 735 of its ownK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
  5. Descendant · 3 generations on · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
  6. Descendant · 4 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004

Showing 5 of 1,113 descendants. See all descendants

Descendants cleared per year

1998: 11999: 32000: 22001: 22002: 62003: 82004: 162005: 212006: 312007: 282008: 422009: 342010: 292011: 432012: 412013: 562014: 482015: 502016: 552017: 512018: 502019: 442020: 762021: 592022: 612023: 752024: 802025: 672026: 34
1998high 80 (2024) · low 1 (1998)2026

Most influential descendants

Showing 5 of 1,113 · See all
  • K984104Iti Dental Implant SystemStraumann USA · 1999 · cites it directly1,043descendants
  • K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc. · 2000 · 2 generations on942descendants
  • K992937Dental ImplantNobel Biocare Uas, Inc. · 2000 · 2 generations on735descendants
  • K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · 3 generations on689descendants
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 4 generations on622descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971578Endosseous Dental ImplantStraumann USA1997—
+1K984104Iti Dental Implant SystemStraumann USA19991
+2K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…Nobel Biocare Uas, Inc.2000—
+2K992937Dental ImplantNobel Biocare Uas, Inc.20001
+3K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200227
+4K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199930
200020
200120
200260
200380
2004160
2005210
2006310
2007280
2008420
2009340
2010290
2011430
2012410
2013560
2014480
2015500
2016550
2017510
2018500
2019440
2020760
2021590
2022610
2023750
2024800
2025670
2026340
FIG. 1 — Lineage of K971578, 1997–2026Source: 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
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? (1,113)

See all 1,113

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

NumberDeviceApplicantDecidedDescendants
K984104Iti Dental Implant SystemStraumann USA19991,043
K983742Iti Dental Implant SystemInstitut Straumann AG1999510
K033984Straumann Dental Implant SystemInstitut Straumann AG2004376
K053088Slactive ImplantsInstitut Straumann AG2006295
K982509Ortho Implant and AccessoriesStraumann USA199866
K990458Straumann Extraoral Implant SystemStraumann USA19992
K052733Almitech Inc. Dental Implant SystemAlmitech, Inc.20050

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, K984104 (Straumann USA, 1999) has gone furthest, with 1,043 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 Straumann USA

41 FDA decisions under this applicant name. See the company

  • K151328PURE Ceramic ImplantsStraumann USA · 2016
  • K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
  • K130724Codiagnostix Implant Planning SoftwareStraumann USA · 2013
  • K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA · 2012
  • K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 20121 recall

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/K971578 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971578: Endosseous Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971578

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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