510(k) Report

510(k) · Cleared

Cleared

Artech Type SS Submerged Screw Implant

K891346510(k) TraditionalCleared Dec 21, 1989286-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

Artech Corp. · DZE Implant, Endosseous, Root-Form

Cleared on Dec 21, 1989 after a 286-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 328 later devices descend from it.

Decided
Dec 21, 1989
Review
286 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

328 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2001: 1 descendant cleared2004: 2 descendants cleared2008: 7 descendants cleared2003: 1 descendant cleared2002: 1 descendant cleared2012: 5 descendants cleared2013: 9 descendants cleared2007: 6 descendants cleared2005: 2 descendants cleared2011: 6 descendants cleared2010: 1 descendant cleared2015: 12 descendants cleared2018: 13 descendants cleared2014: 11 descendants cleared2017: 14 descendants cleared2009: 2 descendants cleared2016: 14 descendants cleared2022: 31 descendants cleared2026: 22 descendants cleared2023: 32 descendants cleared2020: 19 descendants cleared2024: 40 descendants cleared2021: 19 descendants cleared2019: 18 descendants cleared2025: 38 descendants cleared1990200020102020
  1. This deviceK891346 Artech Type SS Submerged Screw ImplantArtech Corp. · 1989
  2. Descendant · cites it directly · 322 of its ownK980620 Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd. · 1998
  3. Descendant · 2 generations on · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
  4. Descendant · 3 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
  5. Descendant · 4 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
  6. Descendant · 3 generations on · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005

Showing 5 of 328 descendants. See all descendants

Descendants cleared per year

1998: 22001: 12002: 12003: 12004: 22005: 22007: 62008: 72009: 22010: 12011: 62012: 52013: 92014: 112015: 122016: 142017: 142018: 132019: 182020: 192021: 192022: 312023: 322024: 402025: 382026: 22
1998high 40 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 328 · See all
  • K980620Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd. · 1998 · cites it directly322descendants
  • K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · 2 generations on319descendants
  • K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 3 generations on318descendants
  • K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 4 generations on317descendants
  • K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · 3 generations on312descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891346Artech Type SS Submerged Screw ImplantArtech Corp.1989—
+1K980620Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd.1998—
+2K0306143I Dental ImplantsImplant Innovations, Inc.2003—
+3K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004—
+4K051189Prevail Dental ImplantsImplant Innovations, Inc.2005—
+3K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200110
200210
200310
200420
200520
200760
200870
200920
201010
201160
201250
201390
2014110
2015120
2016140
2017140
2018130
2019180
2020190
2021190
2022310
2023320
2024400
2025380
2026220
FIG. 1 — Lineage of K891346, 1989–2026Source: 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), 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? (328)

See all 328

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

NumberDeviceApplicantDecidedDescendants
K980620Dentatus Mti Modular Transitional Implants and Prosthetic SystemDentatus USA, Ltd.1998322
K991250Quantum Versatility Implant SystemQuantum Bioengineering, Ltd.20012
K980442Crystal and Crystal-Seal Implants SystemCrystal Medical Technology19981

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, K980620 (Dentatus USA, Ltd., 1998) has gone furthest, with 322 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 Artech Corp.

8 FDA decisions under this applicant name. See the company

  • K911735Artech Ardent IV - Type Clylinder ImplantArtech Corp. · 1992
  • K895267Artech Type SS-HA Submerged Screw ImplantArtech Corp. · 1990
  • K894160Hand Tools for Artech Type SS Submerged Screw ImplArtech Corp. · 1989
  • K894151Irrigated Drill for SS Submerged Screw PlantArtech Corp. · 1989
  • K894150Counterbore for SS Submerged Screw PlantArtech Corp. · 1989

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/K891346 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891346: Artech Type SS Submerged Screw Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891346

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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