510(k) · Cleared
Cleared3.75MM and 5.0MM Spline Twist Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 18, 2002 as substantially equivalent to K992937 (Nobel Biocare Uas, Inc., 2000) and 3 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 18, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894595 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 1 generation backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- This deviceK013494 3.75MM and 5.0MM Spline Twist ImplantSulzer Dental, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −2 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −1 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| 0 (this device) | K013494 | 3.75MM and 5.0MM Spline Twist Implant | Sulzer Dental, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K992937 | Dental ImplantSummary page 1…evice Trade Name: Spline Twist The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental's implant systems are designed for use… | 2000 |
| * | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Summary page 1…Name: Spline Twist The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental's implant systems are designed for use in edentulo… | 2000 |
| * | K984104 | Iti Dental Implant SystemSummary page 1…devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental's implant systems are designed for use in edentulous mandibles or maxillae for at… | 1999 |
| * | K002374 | Iti Dental Implant System Monotype ImplantSummary page 1…d for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374). 1. Intended Use: Sulzer Dental's implant systems are designed for use in edentulous mandibles or maxillae for attachment of… | 2000 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- 6 other devices also cite its predicate K992937.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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?
The Spline Twist implants are intended for surgical implantation in edentulous or
partially 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 freestanding 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. In patients with an edentulous mandible, Spline Twist implants may
be loaded immediately when at least four implants are placed between the mental
foramina and rigidly splinted with a bar.
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/K013494 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013494: 3.75MM and 5.0MM Spline Twist Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013494
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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