510(k) Report

510(k) · Cleared

Cleared

Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems

K073075510(k) TraditionalCleared Mar 31, 2008152-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

Dentsply International, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 31, 2008 as substantially equivalent to K022562 (Nobel Biocare AB, 2002) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 2002. 304 later devices descend from it.

Decided
Mar 31, 2008
Review
152 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K022562 (2002). 304 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2018: 15 descendants cleared2015: 14 descendants cleared2012: 3 descendants cleared2014: 11 descendants cleared2010: 2 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2017: 14 descendants cleared2016: 13 descendants cleared2024: 36 descendants cleared2019: 18 descendants cleared2025: 40 descendants cleared2022: 27 descendants cleared2021: 23 descendants cleared2026: 22 descendants cleared2020: 24 descendants cleared2023: 37 descendants cleared2013: 2 descendants clearedK022562 · Various Branemark System Implants-Immediate Function Indication · Nobel Biocare AB · 2002K041492 · Astra Tech Implants - Dental System · Astra Tech, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 37 descendants3 generations forward: 69 descendants4 generations forward: 83 descendants5 generations forward: 42 descendants6 generations forward: 37 descendants7 generations forward: 15 descendants8 generations forward: 8 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K041492 · Astra Tech Implants - Dental System · Astra Tech, Inc. · 2004K022562 · Various Branemark System Implants-Immediate Function Indication · Nobel Biocare AB · 20020+5+10
  1. Root · 2 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
  2. 1 generation backK041492 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 2004
  3. This deviceK073075 Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental…Dentsply International, Inc. · 2008
  4. Descendant · cites it directly · 290 of its ownK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
  5. Descendant · cites it directly · 200 of its ownK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
  6. Descendant · 2 generations on · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
  7. Descendant · 3 generations on · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012
  8. Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012

Showing 5 of 304 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 22012: 32013: 22014: 112015: 142016: 132017: 142018: 152019: 182020: 242021: 232022: 272023: 372024: 362025: 402026: 22
2009high 40 (2025) · low 1 (2009)2026

Most influential descendants

Showing 5 of 304 · See all
  • K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009 · cites it directly290descendants
  • K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc. · 2010 · cites it directly200descendants
  • K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · 2 generations on199descendants
  • K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · 3 generations on197descendants
  • K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K022562Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB2002—
−1K041492Astra Tech Implants - Dental SystemAstra Tech, Inc.2004—
0 (this device)K073075Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsDentsply International, Inc.2008—
+1K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009—
+1K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010—
+2K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment…Astra Tech, Inc.2010—
+3K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in…Astra Tech, Inc.2012—
+2K120414Osseospeed PlusAstra Tech AB2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201120
201230
201320
2014110
2015140
2016130
2017140
2018150
2019180
2020240
2021230
2022270
2023370
2024360
2025400
2026220
FIG. 1 — Lineage of K073075, 2002–2026Source: 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), 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
*K022562Various Branemark System Implants-Immediate Function Indication
Summary page 1
…ion CLASSIFICATION NAME: Endosseous dental implant (21 CFR 872.3640) PREDICATE DEVICES: Various Brinemark System Implants (K(022562) Astra Tech Implants - Dental System (K(041492) DEVICE DESCRIPTION: The PRIADENT Implant Sy…
Nobel Biocare AB2002—
*K041492Astra Tech Implants - Dental System
Summary page 1
…872.3640) PREDICATE DEVICES: Various Brinemark System Implants (K(022562) Astra Tech Implants - Dental System (K(041492) DEVICE DESCRIPTION: The PRIADENT Implant Systems consist of root-formed threaded screws made from commercially pure titanium an…
Astra Tech, Inc.2004—

Also cleared against K022562: 18 other devices →

What descends from it? (304)

See all 304

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

NumberDeviceApplicantDecidedDescendants
K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009290
K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200
K170588DESS Dental Smart SolutionsTerrats Medical SL201786
K173908DESS Dental Smart SolutionsTerrats Medical SL201851
K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811
K142167Medentika Abutment SystemMedentika GmbH20157
K102822Implant-One SystemCustom Dental Implants, Inc.20113
K131066Axiom RegAnthogyr Sas20142
K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122
K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150

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?

  • The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K083805 (Dentsply Intl., Inc., 2009) has gone furthest, with 290 descendants of its own.
  • 18 other devices also cite its predicate K022562.

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. 2008, this device’s year, is highlighted.

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 FRIADENT Implant systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System) are for single-stage or two-stage surgical procedures and cemented or screw retained restorations. The FRIADENT Implant Systems are intended for immediate placement and fimction on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occiusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Indications for use as stated in the FDA summary.

Also cleared against K022562

18 other devices cite the same predicate.

  • K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017
  • K142167Medentika Abutment SystemMedentika GmbH · 2015
  • K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L. · 2010
  • K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
  • K061971Zirconia ImplantNobel Biocare AB · 2007

More from Dentsply International, Inc.

36 FDA decisions under this applicant name. See the company

  • K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
  • K160232Disposable Barrier Sleeves and CoversDentsply International, Inc. · 2016
  • K151439Atlantis IsusDentsply International, Inc. · 2016
  • K152247ATLANTIS CrownDentsply International, Inc. · 2016
  • K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc. · 2016

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/K073075 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073075

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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