510(k) Report

510(k) · Cleared

Cleared

Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA

K994376510(k) TraditionalCleared Mar 24, 200088-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

Friadent GmbH · DZE Implant, Endosseous, Root-Form

Cleared on Mar 24, 2000 as substantially equivalent to K925765 (Nobelpharma USA, Inc., 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 665 later devices descend from it.

Decided
Mar 24, 2000
Review
88 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K925765 (1993). 665 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2008: 14 descendants cleared2003: 7 descendants cleared2002: 2 descendants cleared2005: 7 descendants cleared2007: 18 descendants cleared2004: 5 descendants cleared2006: 6 descendants cleared2010: 11 descendants cleared2014: 23 descendants cleared2012: 21 descendants cleared2015: 35 descendants cleared2013: 30 descendants cleared2011: 21 descendants cleared2016: 35 descendants cleared2009: 11 descendants cleared2018: 35 descendants cleared2017: 31 descendants cleared2019: 30 descendants cleared2021: 45 descendants cleared2025: 49 descendants cleared2022: 44 descendants cleared2024: 60 descendants cleared2020: 43 descendants cleared2026: 29 descendants cleared2023: 53 descendants clearedK925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 19931990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 14 descendants3 generations forward: 48 descendants4 generations forward: 128 descendants5 generations forward: 162 descendants6 generations forward: 113 descendants7 generations forward: 93 descendants8 generations forward: 67 descendants9 generations forward: 22 descendants10 generations forward: 5 descendants11 generations forward: 4 descendants12 generations forward: 3 descendants K925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 19930+5+10
  1. Root · 1 generation backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
  2. This deviceK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
  3. Descendant · cites it directly · 583 of its ownK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
  4. Descendant · 2 generations on · 478 of its ownK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  5. Descendant · cites it directly · 391 of its ownK031674 Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003
  6. Descendant · 2 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
  7. Descendant · 2 generations on · 361 of its ownK062069 Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007

Showing 5 of 665 descendants. See all descendants

Descendants cleared per year

2002: 22003: 72004: 52005: 72006: 62007: 182008: 142009: 112010: 112011: 212012: 212013: 302014: 232015: 352016: 352017: 312018: 352019: 302020: 432021: 452022: 442023: 532024: 602025: 492026: 29
2002high 60 (2024) · low 2 (2002)2026

Most influential descendants

Showing 5 of 665 · See all
  • K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002 · cites it directly583descendants
  • K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002 · 2 generations on478descendants
  • K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003 · cites it directly391descendants
  • K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
  • K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc. · 2007 · 2 generations on361descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925765Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc.1993—
0 (this device)K994376Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2…Friadent GmbH2000—
+1K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
+2K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
+1K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH2003—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004—
+2K062069Atlantis Abutment for 3I Micromini ImplantAtlantis Components, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200370
200450
200570
200660
2007180
2008140
2009110
2010110
2011210
2012210
2013300
2014230
2015350
2016350
2017310
2018350
2019300
2020430
2021450
2022440
2023530
2024600
2025490
2026290
FIG. 1 — Lineage of K994376, 1993–2026Source: 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? (2)

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
*K925765Branemark System Standard 3.75MM Fixture
Summary page 1
…n Name: Endosseous Dental Implants 21 CFR 872.3640 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared Nobel BioCare Branemark System Standard K925765 10/05/93 3.75mm Fixture 187 FRIADENT GmbH FRIALIT-2® 3.4mm Dental Implant Original Premarket 510(k) Notification…
Nobelpharma USA, Inc.1993—
*—FRIALIT-2® Dental Implant Systems
Named without a submission number
—

Also cleared against K925765: 4 other devices →

What descends from it? (665)

See all 665

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

NumberDeviceApplicantDecidedDescendants
K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002583
K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH2003391
K0306143I Dental ImplantsImplant Innovations, Inc.2003319
K030639Xive 3.0 Dental Implant SystemFriandent GmbH20039
K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl.20080
K042971Titan Dental Implant SystemTitan Implants, 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?

  • Its one ancestor has no recall.
  • Of its descendants, K014235 (Implant Innovations, Inc., 2002) has gone furthest, with 583 descendants of its own.
  • 4 other devices also cite its predicate K925765.

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 FRIALIT-2® Dental Implant System is intended for use in

single tooth restoration, edentulous spans restored with

multiple single teeth, free-standing bridges and to retain

overdentures. The implants can be used after extraction for

immediate implant placement, delayed immediate implant

placement or late implant placement.

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 K925765

4 other devices cite the same predicate.

  • K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10…Promimic AB · 2011
  • K021355Endosseous ImplantBranemark Integration AB · 2002
  • K983120Bicortical ScrewOraltronics Marketing-Und Vertriebs GmbH · 1999
  • K984104Iti Dental Implant SystemStraumann USA · 19991 recall

More from Friadent GmbH

18 FDA decisions under this applicant name. See the company

  • K040170Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
  • K041509Ankylos Dental Implant SystemFriadent GmbH · 2004
  • K040946Ankylos Dental Implant SystemFriadent GmbH · 2004
  • K032302Xive TG AbutmentsFriadent GmbH · 2003
  • K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH · 2003

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/K994376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K994376: Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994376

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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