510(k) Report

510(k) · Cleared

Cleared

Sulzer Dental Ceramic System-Spline

K014214510(k) TraditionalCleared Mar 19, 200288-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

Sulzer Dental, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 19, 2002 as substantially equivalent to K943180 (Calcitek, Inc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995.

Decided
Mar 19, 2002
Review
88 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K943180 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK943180 · Integral IV Biointegrated Dental Implant System · Calcitek, Inc. · 199519961998200020022004
Other ancestors, by generation 1 generation back: 1 other ancestor K943180 · Integral IV Biointegrated Dental Implant System · Calcitek, Inc. · 19950
  1. Root · 1 generation backK943180 Integral IV Biointegrated Dental Implant SystemCalcitek, Inc. · 1995
  2. This deviceK014214 Sulzer Dental Ceramic System-SplineSulzer Dental, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943180Integral IV Biointegrated Dental Implant SystemCalcitek, Inc.1995—
0 (this device)K014214Sulzer Dental Ceramic System-SplineSulzer Dental, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K014214, 1995–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K943180Integral IV Biointegrated Dental Implant System
Summary page 1
…ent for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-Spline The Primary device used for comparison in this summary is the Gold Coping Abutment (K943180) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use: The Sulzer Dental Ceramic System - Spline is intended for use…
Calcitek, Inc.1995—
*K980630Frialit-2 Corabase
Summary page 1
…: Sulzer Dental Ceramic System-Spline The Primary device used for comparison in this summary is the Gold Coping Abutment (K943180) and the FRIALIT®-2 CeraBase Abutment (K980630) 1. Intended Use: The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-…
Friatec AG1998—

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?

  • None of the 2 ancestors has a recall.

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.

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?

The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be sed in the molars and should not be splinted together for multiple unit cases, partials or bridgework.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Sulzer Dental, Inc.

9 FDA decisions under this applicant name. See the company

  • K014050Hex-Lock Temporary AbutmentSulzer Dental, Inc. · 2002
  • K014175Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc. · 2002
  • K0134943.75MM and 5.0MM Spline Twist ImplantSulzer Dental, Inc. · 2002
  • K013227Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 20012 recalls
  • K0120553.25MM Spline Twist ImplantSulzer Dental, Inc. · 2001

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/K014214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014214: Sulzer Dental Ceramic System-Spline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014214

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026