510(k) · Cleared

Cleared

3.25MM Spline Twist Implant

K012055510(k) TraditionalCleared Sep 6, 200166-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 Sep 6, 2001 as substantially equivalent to K944327 (Calcitek, Inc., 1995) and 2 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Sep 6, 2001
Review: 66 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K944327 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK944327 Integral VI Biointegrated Dental Implant SystemCalcitek, Inc. · 1995
This deviceK012055 3.25MM Spline Twist ImplantSulzer Dental, Inc. · 2001
Descendant · cites it directly · 0 of its ownK093164 3.25 Spline Twist Implant, HA CoatedZimmer Dental, Inc. · 2009 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K0931643.25 Spline Twist Implant, HA CoatedZimmer Dental, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944327	Integral VI Biointegrated Dental Implant System	Calcitek, Inc.	1995	—
0 (this device)	K012055	3.25MM Spline Twist Implant	Sulzer Dental, Inc.	2001	—
+1	K093164	3.25 Spline Twist Implant, HA Coated	Zimmer Dental, Inc.	2009	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K012055, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K944327	Integral VI Biointegrated Dental Implant System Summary page 2 …comparison of the Spline Twist implant and the predicate device. Table 1: Summary of Comparison Feature Small Diameter Spline Predicate Device Predicate Twilst Implant K944327 & K946311 Device K962106 “Tmplant body geomeiry \| Tapered, Self-Tapping Cylinder Self-Tapping : Screw Screw Type Implant Lengths…	Calcitek, Inc.	1995	—
*	K946311	Integral Vii 3.25MM Biointegrated Dental Implant System Summary page 2 …n of the Spline Twist implant and the predicate device. Table 1: Summary of Comparison Feature Small Diameter Spline Predicate Device Predicate Twilst Implant K944327 & K946311 Device K962106 “Tmplant body geomeiry \| Tapered, Self-Tapping Cylinder Self-Tapping : Screw Screw Type Implant Lengths 10,11.5,13…	Calcitek, Inc.	1995	—
*	K962106	Spline Dental Implant Systems Summary page 2 …Twist implant and the predicate device. Table 1: Summary of Comparison Feature Small Diameter Spline Predicate Device Predicate Twilst Implant K944327 & K946311 Device K962106 “Tmplant body geomeiry \| Tapered, Self-Tapping Cylinder Self-Tapping : Screw Screw Type Implant Lengths 10,11.5,13,15& 810,13, 15…	Calcitek, Inc.	1996	—

Also cleared against K944327: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093164	3.25 Spline Twist Implant, HA Coated	Zimmer Dental, Inc.	2009	0

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 3 ancestors has a recall.
Of its descendants, K093164 (Zimmer Dental, Inc., 2009) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K944327.

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

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

Sulzer Dental Implant Systems are designed for use in edentulous mandibles or maxillae

for attachment of complete denture prostheses, or as a terminal or intermediary abutment

for fixed or removable bridgework, or as a free standing single tooth replacement. The

use of the 5.0mm implant is recommended when the quantity and density of bone would

dictate the use of an implant larger than 4.0mm. The 3.15mm implant is recommended

for the anterior mandible and the maxillary laterals for replacement of teeth in narrow

interproximal areas and narrow ridges.

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

https://510kreport.com/device/K012055 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012055: 3.25MM Spline Twist Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012055

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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