510(k) Report

510(k) · Cleared

Cleared

Hahn Tapered Implant System

K143353510(k) TraditionalCleared Apr 2, 2015129-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 Apr 2, 2015 as substantially equivalent to K121406 (Prismatik Dentalcraft, Inc., 2013) after a 129-day review. Its family tree reaches back 3 generations to 2003. 10 later devices descend from it.

Decided
Apr 2, 2015
Review
129 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K031106 (2003). 5 ancestors in all, the oldest K953235 (1995). 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor2016: 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. · 2010K121406 · Inclusive Tapered Implant System · Prismatik Dentalcraft, Inc. · 20131995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 1 descendant K121406 · Inclusive Tapered Implant System · Prismatik Dentalcraft, Inc. · 2013K100932 · 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 · 3 generations backK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003 · Recalled
  2. 2 generations backK100932 Inclusive Mini ImplantPrismatik Dentalcraft, Inc. · 2010
  3. 1 generation backK121406 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2013
  4. This deviceK143353 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
  9. Descendant · 3 generations on · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22019: 12022: 12023: 22024: 12025: 12026: 1
2016high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22…Imtec Corp.20031
−2K100932Inclusive Mini ImplantPrismatik Dentalcraft, Inc.2010—
−1K121406Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.2013—
0 (this device)K143353Hahn 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—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
201910
202210
202320
202410
202510
202610
FIG. 1 — Lineage of K143353, 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? (1)

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
*K121406Inclusive Tapered Implant System
Summary page 5
…9 C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: Inclusive Tapered Implant System (K121406) D. DEVICE DESCRIPTION The Hahn Tapered Implant System consists of dental implants, abutments, screws, and surgical…
Prismatik Dentalcraft, Inc.2013—

Also cleared against K121406: 2 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
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 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K170044 (Prismatik Dentalcraft, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K121406.

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. 2015, 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?

Hahn Implants are indicated for use in maxillary and mandibular partially or fully edentulous cases. to support single, multiple-unit, and overdenture restorations. The implants are to be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

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 K121406

2 other devices cite the same predicate.

  • K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc. · 2017
  • K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016

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/K143353 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143353: Hahn Tapered Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143353

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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