510(k) Report

510(k) · Cleared

Cleared

Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452S

K061847510(k) TraditionalCleared Oct 12, 2006104-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 12, 2006 after a 104-day review. The FDA summary names its predicate without a number. 34 later devices descend from it.

Decided
Oct 12, 2006
Review
104 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2011: 1 descendant cleared2008: 1 descendant cleared2014: 4 descendants cleared2015: 2 descendants cleared2018: 3 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2017: 1 descendant cleared2022: 4 descendants cleared2020: 2 descendants cleared2024: 4 descendants cleared2023: 1 descendant cleared2026: 2 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK061847 Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S…Zimmer Dental, Inc. · 2006
  2. Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
  3. Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
  4. Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
  5. Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
  6. Descendant · cites it directly · 3 of its ownK102822 Implant-One SystemCustom Dental Implants, Inc. · 2011

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12014: 42015: 22016: 22017: 12018: 32019: 42020: 22021: 22022: 42023: 12024: 42025: 12026: 2
2008high 4 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 34 · See all
  • K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
  • K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
  • K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
  • K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
  • K102822Implant-One SystemCustom Dental Implants, Inc. · 2011 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061847Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452SZimmer Dental, Inc.2006—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.2014—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.2014—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.2016—
+2K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.2017—
+1K102822Implant-One SystemCustom Dental Implants, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201440
201520
201620
201710
201830
201940
202020
202120
202240
202310
202440
202510
202620
FIG. 1 — Lineage of K061847, 2006–2026Source: 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? (2)

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
*—ASTRATech ZirDesign TM Ceramic Abutment
Named without a submission number
—
*—Zimmer Hex-Lock Abutment
Named without a submission number
—

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425
K102822Implant-One SystemCustom Dental Implants, Inc.20113
K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083

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, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 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.

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 Zimmer© Contour Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit implant-supported restoration. The 3.5mm abutment is used in the anterior, cuspid, and premolar regions. The 4.5mm abutment can be used in any region of the mouth.

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/K061847 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061847: Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061847

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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