510(k) Report

510(k) · Cleared

Cleared

Endosseous Dental Implant & Accessories

K955281510(k) TraditionalCleared Mar 15, 1996120-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

The Straumann Co. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 15, 1996 as substantially equivalent to K894595 (Institut Straumann AG, 1990) and 3 other predicates after a 120-day review. Its family tree reaches back 1 generation to 1990. 27 later devices descend from it.

Decided
Mar 15, 1996
Review
120 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K894595 (1990). 4 ancestors in all. 27 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor1992: 1 other ancestor2001: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2007: 2 descendants cleared2018: 5 descendants cleared2017: 2 descendants cleared2013: 1 descendant cleared2008: 1 descendant cleared2020: 3 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2024: 2 descendants cleared2026: 1 descendant cleared2022: 1 descendant clearedK894595 · Bonefit R Screw Implants · Institut Straumann AG · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 5 descendants K894595 · Bonefit R Screw Implants · Institut Straumann AG · 19900+5
  1. Root · 1 generation backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. This deviceK955281 Endosseous Dental Implant & AccessoriesThe Straumann Co. · 1996
  3. Descendant · cites it directly · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
  4. Descendant · 2 generations on · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
  5. Descendant · 2 generations on · 17 of its ownK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
  7. Descendant · 3 generations on · 7 of its ownK163060 Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2001: 12004: 12006: 12007: 22008: 12013: 12017: 22018: 52020: 32021: 22022: 12023: 42024: 22026: 1
2001high 5 (2018) · low 0 (2002)2026

Most influential descendants

Showing 5 of 27 · See all
  • K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · cites it directly24descendants
  • K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 2 generations on21descendants
  • K070905Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 2 generations on17descendants
  • K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 3 generations on13descendants
  • K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd. · 2017 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K894595Bonefit R Screw ImplantsInstitut Straumann AG1990—
0 (this device)K955281Endosseous Dental Implant & AccessoriesThe Straumann Co.1996—
+1K061169Endosseous Dental ImplantNorthern Implants, LLC2006—
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.2007—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.20071
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.20171
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200610
200720
200810
201310
201720
201850
202030
202120
202210
202340
202420
202610
FIG. 1 — Lineage of K955281, 1990–2026Source: 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? (5)

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
*K894595Bonefit R Screw Implants
Summary page 1
…accessories Classification Name: Endosseous dental implant Legally marketed devices to which equivalence is claimed (predicate devices) ITt 4.1 mm Solid Screw Implant (K894595, K920768) Nobelpharma Branemark System - 5.5 mm Fixture {(K926501) Implant Innovations, Inc. wiJ; diameter implants (K number unk…
Institut Straumann AG1990—
*K920768Hollow Screw Implants 6MM, 14MM, 16MM
Summary page 1
…es Classification Name: Endosseous dental implant Legally marketed devices to which equivalence is claimed (predicate devices) ITt 4.1 mm Solid Screw Implant (K894595, K920768) Nobelpharma Branemark System - 5.5 mm Fixture {(K926501) Implant Innovations, Inc. wiJ; diameter implants (K number unknown) Lif…
The Straumann Co.1992—
*K926501Branemark System (R) - 5.5MM Fixture
Summary page 1
…y marketed devices to which equivalence is claimed (predicate devices) ITt 4.1 mm Solid Screw Implant (K894595, K920768) Nobelpharma Branemark System - 5.5 mm Fixture {(K926501) Implant Innovations, Inc. wiJ; diameter implants (K number unknown) Lifecore Biomedical Wide Diameter Implant (K944068) Descrip…
Nobelpharma USA, Inc.1993—
*K944068Restore Self Tapping Dental Implant Syst (5, 5.5,6MM)
Summary page 1
…) Nobelpharma Branemark System - 5.5 mm Fixture {(K926501) Implant Innovations, Inc. wiJ; diameter implants (K number unknown) Lifecore Biomedical Wide Diameter Implant (K944068) Description of the device Implants Thg ITI Wide Diameter Implant is a one-stoge root-form design made of commercially re titan…
Lifecore Biomedical, Inc.1995—
*—Implant Innovations, Inc. wide diameter implants
Named without a submission number
—

Also cleared against K894595: 6 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K061169Endosseous Dental ImplantNorthern Implants, LLC200624
K034067Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc.20040
K991822Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long…Dr. Ihde Dental AG Switzerland20010

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K061169 (Northern Implants, LLC, 2006) has gone furthest, with 24 descendants of its own.
  • 6 other devices also cite its predicate K894595.

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 device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is intended for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K894595

6 other devices cite the same predicate.

  • K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006
  • K052733Almitech Inc. Dental Implant SystemAlmitech, Inc. · 2005
  • K994205Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc. · 2000
  • K991114Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc. · 1999
  • K984104Iti Dental Implant SystemStraumann USA · 19991 recall
  • K983742Iti Dental Implant SystemInstitut Straumann AG · 1999

More from The Straumann Co.

14 FDA decisions under this applicant name. See the company

  • K041070Straumann Temporary CopingThe Straumann Co. · 2004
  • K040646Straumann GranulesThe Straumann Co. · 2004
  • K040469The Straumann Ortho Implant SystemThe Straumann Co. · 2004
  • K993862Modus Sagittal Split PlateThe Straumann Co. · 1999
  • K962023Plastic Protection Healing CapsThe Straumann Co. · 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/K955281 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955281: Endosseous Dental Implant & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955281

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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