510(k) Report

510(k) · Cleared

Cleared

Frialit (R)-2 Stepped Screw with Deep Profile Surface

K945847510(k) TraditionalCleared Mar 15, 1996471-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

Friatec Medical Inc., USA · DZE Implant, Endosseous, Root-Form

Cleared on Mar 15, 1996 after a 471-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 570 later devices descend from it.

Decided
Mar 15, 1996
Review
471 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

570 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 5 descendants cleared2002: 2 descendants cleared2004: 4 descendants cleared2008: 11 descendants cleared2007: 5 descendants cleared2015: 31 descendants cleared2005: 3 descendants cleared2006: 5 descendants cleared2014: 24 descendants cleared2010: 10 descendants cleared2012: 19 descendants cleared2013: 22 descendants cleared2011: 12 descendants cleared2009: 6 descendants cleared2016: 31 descendants cleared2017: 27 descendants cleared2021: 39 descendants cleared2018: 29 descendants cleared2025: 48 descendants cleared2022: 38 descendants cleared2024: 57 descendants cleared2020: 41 descendants cleared2019: 27 descendants cleared2023: 50 descendants cleared2026: 24 descendants cleared1995200020052010201520202025
  1. This deviceK945847 Frialit (R)-2 Stepped Screw with Deep Profile SurfaceFriatec Medical Inc., USA · 1996
  2. Descendant · cites it directly · 568 of its ownK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
  3. Descendant · 2 generations on · 547 of its ownK021318 Xive Dental Implant SystemFriadent GmbH · 2002
  4. Descendant · 3 generations on · 542 of its ownK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
  5. Descendant · 2 generations on · 425 of its ownK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
  6. Descendant · 3 generations on · 394 of its ownK032284 Xive TG Dental Implant SystemFriadent GmbH · 2003

Showing 5 of 570 descendants. See all descendants

Descendants cleared per year

2002: 22003: 52004: 42005: 32006: 52007: 52008: 112009: 62010: 102011: 122012: 192013: 222014: 242015: 312016: 312017: 272018: 292019: 272020: 412021: 392022: 382023: 502024: 572025: 482026: 24
2002high 57 (2024) · low 2 (2002)2026

Most influential descendants

Showing 5 of 570 · See all
  • K013067Frialoc Dental Implant SystemFriadent GmbH · 2002 · cites it directly568descendants
  • K021318Xive Dental Implant SystemFriadent GmbH · 2002 · 2 generations on547descendants
  • K032158Xive Dental Implant System MultipleFriadent GmbH · 2003 · 3 generations on542descendants
  • K024004Xive Transgingival Dental Implant SystemFriadent GmbH · 2003 · 2 generations on425descendants
  • K032284Xive TG Dental Implant SystemFriadent GmbH · 2003 · 3 generations on394descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945847Frialit (R)-2 Stepped Screw with Deep Profile SurfaceFriatec Medical Inc., USA1996—
+1K013067Frialoc Dental Implant SystemFriadent GmbH2002—
+2K021318Xive Dental Implant SystemFriadent GmbH2002—
+3K032158Xive Dental Implant System MultipleFriadent GmbH2003—
+2K024004Xive Transgingival Dental Implant SystemFriadent GmbH2003—
+3K032284Xive TG Dental Implant SystemFriadent GmbH2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200350
200440
200530
200650
200750
2008110
200960
2010100
2011120
2012190
2013220
2014240
2015310
2016310
2017270
2018290
2019270
2020410
2021390
2022380
2023500
2024570
2025480
2026240
FIG. 1 — Lineage of K945847, 1996–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (570)

See all 570

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

NumberDeviceApplicantDecidedDescendants
K013067Frialoc Dental Implant SystemFriadent GmbH2002568
K031674Modification to Frialit-2 Dental Implant SystemFriadent GmbH2003391

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, K013067 (Friadent GmbH, 2002) has gone furthest, with 568 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 Friatec Medical Inc., USA

4 FDA decisions under this applicant name. See the company

  • K945849Frialit (R)-2 Stepped Cylinder with Frios (R) TI-CoatingFriatec Medical Inc., USA · 1996
  • K945848Frialit (R)-2 Dental ImplantFriatec Medical Inc., USA · 1996
  • K934332Surgical Instruments, Forceps & Graspers, Probes & CurettesFriatec Medical Inc., USA · 1994

Recent decisions in DZE

The DZE category page

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https://510kreport.com/device/K945847 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945847: Frialit (R)-2 Stepped Screw with Deep Profile Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945847

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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