510(k) Report

510(k) · Cleared

Cleared

Inclusive Tapered Implant System

K121406510(k) TraditionalCleared Feb 22, 2013288-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

Prismatik Dentalcraft, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Feb 22, 2013 as substantially equivalent to K100932 (Prismatik Dentalcraft, Inc., 2010) and 2 other predicates after a 288-day review. Its family tree reaches back 2 generations to 2003. 11 later devices descend from it.

Decided
Feb 22, 2013
Review
288 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K031106 (2003). 4 ancestors in all, the oldest K953235 (1995). 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor2016: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2019: 1 descendant cleared2022: 1 descendant cleared2023: 2 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK031106 · Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX · Imtec Corp. · 2003 · recalledK100932 · Inclusive Mini Implant · Prismatik Dentalcraft, Inc. · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K100932 · Inclusive Mini Implant · Prismatik Dentalcraft, Inc. · 2010K031106 · Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX · Imtec Corp. · 2003 · recalled0
  1. Root · 2 generations backK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003 · Recalled
  2. 1 generation backK100932 Inclusive Mini ImplantPrismatik Dentalcraft, Inc. · 2010
  3. This deviceK121406 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2013
  4. Descendant · cites it directly · 10 of its ownK143353 Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2015
  5. Descendant · cites it directly · 5 of its ownK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
  6. Descendant · 2 generations on · 4 of its ownK191222 Inclusive Titanium Abutments compatible with: Dentsply Implants…Prismatik Dentalcraft, Inc. · 2019
  7. Descendant · cites it directly · 3 of its ownK153099 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016
  8. Descendant · 2 generations on · 2 of its ownK171728 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 22019: 12022: 12023: 22024: 12025: 12026: 1
2015high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K143353Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2015 · cites it directly10descendants
  • K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc. · 2017 · cites it directly5descendants
  • K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc. · 2019 · 2 generations on4descendants
  • K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016 · cites it directly3descendants
  • K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22…Imtec Corp.20031
−1K100932Inclusive Mini ImplantPrismatik Dentalcraft, Inc.2010—
0 (this device)K121406Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.2013—
+1K143353Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc.2015—
+1K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.2017—
+2K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech…Prismatik Dentalcraft, Inc.2019—
+1K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.2016—
+2K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201720
201910
202210
202320
202410
202510
202610
FIG. 1 — Lineage of K121406, 2003–2026Source: 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? (3)

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
*K100932Inclusive Mini Implant
Summary page 2
…Dental APRISMATIK DENTALCRAFT, INC, C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Inclusive® Mini Implant (K100932), Sulzer's Screw-Vent Dental Implant System (KOI 1028)…
Prismatik Dentalcraft, Inc.2010—
*K011028Screw-Vent Dental Implant System
Summary page 2
…e Inclusive® Tapered Implant System is substantially equivalent to Prismatik's Inclusive®D Mini Implant (K100932), Sulzer's Screw-Vent Dental Implant System (K01 1028) and the KIS-Krauser Implant System (K95 323 5-Transferred to Glidewell Laboratories/Prismatik Dentalcraft, Inc., 2/2011).…
Sulzer Dental, Inc.20012
*K953235Screw Implants, Grade 3; Uncoated, HA, TP-K3
Summary page 2
…Sulzer's Screw-Vent Dental Implant System (KOI 1028) and KIS-Krauser Implant System (K953235- Transifered to Glidewell Laboratories/Prismatik…
The Implant Center of the Palm Beaches1995—

Also cleared against K100932: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K143353Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc.201510
K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175
K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.20163

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 10 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K143353 (Prismatik Dentalcraft, Inc., 2015) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K100932.

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. 2013, 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?

Inclusivee Tapered Implants are indicated for use in maxiliay and mandibular partially or fidly edentmujou cases to support Single, mnultiple-unit, and overden~tute estorations The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal

Indications for use as stated in the FDA summary.

Also cleared against K100932

2 other devices cite the same predicate.

  • K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC · 2012
  • K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012

More from Prismatik Dentalcraft, Inc.

59 FDA decisions under this applicant name. See the company

  • K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc. · 2026
  • K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc. · 2026
  • K254283BruxZir® Shaded 16 PLUSPrismatik Dentalcraft, Inc. · 2026
  • K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant…Prismatik Dentalcraft, Inc. · 2025
  • K252446BruxZir® NOWPrismatik Dentalcraft, Inc. · 2025

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/K121406 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121406: Inclusive Tapered Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121406

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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