510(k) Report

510(k) · Cleared

Cleared

Zimmer Contour Provisional Coping

K113092510(k) TraditionalCleared Jan 23, 201296-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 Jan 23, 2012 as substantially equivalent to K061043 (Zimmer Dental, Inc., 2006) and 2 other predicates after a 96-day review. Its family tree reaches back 2 generations to 1995.

Decided
Jan 23, 2012
Review
96 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K953101 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 1 other ancestor2006: 1 other ancestorK953101 · Paragon Implant System · Core-Vent Bio-Engineering, Inc. · 1995K090723 · Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5, · Zimmer Dental, Inc. · 20091995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K090723 · Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5, · Zimmer Dental, Inc. · 2009K953101 · Paragon Implant System · Core-Vent Bio-Engineering, Inc. · 19950
  1. Root · 2 generations backK953101 Paragon Implant SystemCore-Vent Bio-Engineering, Inc. · 1995
  2. 1 generation backK090723 Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561…Zimmer Dental, Inc. · 2009
  3. This deviceK113092 Zimmer Contour Provisional CopingZimmer Dental, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K953101Paragon Implant SystemCore-Vent Bio-Engineering, Inc.1995—
−1K090723Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short…Zimmer Dental, Inc.2009—
0 (this device)K113092Zimmer Contour Provisional CopingZimmer Dental, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
FIG. 1 — Lineage of K113092, 1995–2012Source: 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 30.6 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K061043Zimmer Contour Restorative System
Summary page 1
…3. Predicate Device(s): Predicate Device No. 1 Trade Name: Zimmer® Contour Provisional Coping 51 0(k) Number: K061043 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseou…
Zimmer Dental, Inc.2006—
*K090723Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing…
Summary page 2
…0 (ph) 760.431.7811 (fax) Predicate Device No. 2 Trade Name: Zimmer@ Short Provisional Coping 510(k) Number: K090723 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Imp…
Zimmer Dental, Inc.2009—
*K092377Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S…
Summary page 2
…Name: Endosseous Dental Implant Abutment Predicate Device No. 3 Trade Name: Zimmer@ Plastic Temporary Abutment 510(k) Number: K092377 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Imp…
Zimmer Dental, Inc.2009—

Also cleared against K061043: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K061043.

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. 2012, 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 Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days. The Short Provisional Coping is for use with a Short…

Read the full statement (122 words)

The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

Indications for use as stated in the FDA summary.

Also cleared against K061043

1 other device cites the same predicate.

  • K090723Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4…Zimmer Dental, Inc. · 2009

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

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https://510kreport.com/device/K113092 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113092: Zimmer Contour Provisional Coping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113092

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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