510(k) Report

510(k) · Cleared

Cleared

TI Prepable Abutment, Model 1618, 1619, 1620

K092403510(k) TraditionalCleared Oct 30, 200985-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Oct 30, 2009 after an 85-day review. The FDA summary names its predicate without a number. 76 later devices descend from it.

Decided
Oct 30, 2009
Review
85 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 2 descendants cleared2014: 5 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2021: 6 descendants cleared2015: 3 descendants cleared2019: 5 descendants cleared2016: 5 descendants cleared2017: 2 descendants cleared2024: 8 descendants cleared2022: 9 descendants cleared2020: 6 descendants cleared2018: 2 descendants cleared2023: 7 descendants cleared2025: 9 descendants cleared2026: 5 descendants cleared20052010201520202025
  1. This deviceK092403 TI Prepable Abutment, Model 1618, 1619, 1620Zimmer Dental, Inc. · 2009
  2. Descendant · cites it directly · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
  3. Descendant · 2 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
  4. Descendant · cites it directly · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
  5. Descendant · 2 generations on · 29 of its ownK122295 Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013
  6. Descendant · 3 generations on · 26 of its ownK151621 BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 12014: 52015: 32016: 52017: 22018: 22019: 52020: 62021: 62022: 92023: 72024: 82025: 92026: 5
2011high 9 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 76 · See all
  • K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · cites it directly45descendants
  • K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 2 generations on36descendants
  • K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · cites it directly30descendants
  • K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L. · 2013 · 2 generations on29descendants
  • K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc. · 2016 · 3 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092403TI Prepable Abutment, Model 1618, 1619, 1620Zimmer Dental, Inc.2009—
+1K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.20111
+2K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.2012—
+1K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.2011—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.2013—
+3K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201310
201450
201530
201650
201720
201820
201950
202060
202160
202290
202370
202480
202590
202650
FIG. 1 — Lineage of K092403, 2009–2026Source: 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 NHA? 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 NHA device

  1. #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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
*—Integral VII 3.25mm Biointegrated Dental Implant System (Fixed Abutment)
Named without a submission number
—

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.201145
K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130
K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.20142

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, K103691 (BioHorizons Implant Systems, Inc., 2011) has gone furthest, with 45 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

Indications for use as stated in the FDA summary.

More from Zimmer Dental, Inc.

40 FDA decisions under this applicant name. See the company

  • K160398MRI Compatibility for Existing Zimmer Dental Implant SystemsZimmer Dental, Inc. · 2017
  • K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
  • K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant SystemZimmer Dental, Inc. · 2015
  • K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant SystemZimmer Dental, Inc. · 2015
  • K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc. · 2014

Recent decisions in NHA

The NHA category page

  • K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2026
  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K092403 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092403: TI Prepable Abutment, Model 1618, 1619, 1620.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092403

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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