510(k) · Cleared
ClearedSpiralTech Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiraltech Superior Dental Implants, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 30, 2017 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) after a 143-day review. Its family tree reaches back 8 generations to 1990. 8 later devices descend from it.
- Decided
- Jun 30, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 22 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK170372 SpiralTech Dental Implant SystemSpiraltech Superior Dental Implants, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK182293 OsseOne Dental Implant SystemSynoross Dba Osseone · 2019
- Descendant · 2 generations on · 4 of its ownK240837 TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK250872 Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
- Descendant · 3 generations on · 0 of its ownK250176 DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182293OsseOne Dental Implant SystemSynoross Dba Osseone · 2019 · cites it directly5descendants
- K240837TOV Dental Implant SystemRdj Tov Implant, Ltd. · 2024 · 2 generations on4descendants
- K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd. · 2025 · 3 generations on0descendants
- K233271OsseOne Dental Implant SystemSynoross Dba Osseone · 2025 · 2 generations on0descendants
- K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | 2017 | — |
| +1 | K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | 2019 | — |
| +2 | K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | 2024 | — |
| +3 | K250872 | Bioline Dental Implant System | Bioline Dental Implant Systems, Ltd. | 2025 | — |
| +2 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025 | — |
| +3 | K250176 | DAND Dental Implant System | D.A.N.D. Metal Industries North, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 4…stem Classification Name: endosseous dental implant Regulation Number: 21 CFR 872.3640 Product Code: DZE Secondary Product Code: NHA Predicate Device: Nobel Biocare K071370 Reference Devices: Implants – Nobel Biocare K133731 K020646 K102436 Biohorizons K121787 Zimmer K082639 MIS K080162 K103089 Abutm… | 2007 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 2002 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K121787 | Biohorizons Tapered Internal Plus Implants | 2012 |
| † | K082639 | Zimmer Dental Tapered Swissplus Implants | 2008 |
| † | K080162 | Uno - One Piece Screw-Type Dental Implant | 2008 |
| † | K103089 | Seven Implants; Biocom Implants; Lance Implants | 2011 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K063364 | Alpha Bio Dental Implant System | 2007 |
| † | K112162 | Conical Connection Implants | 2012 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K182293 (Synoross Dba Osseone, 2019) has gone furthest, with 5 descendants of its own.
- 28 other devices also cite its predicate K071370.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth , in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good…
Read the full statement (152 words)
The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth , in order to restore patients esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period.
Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.
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/K170372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170372: SpiralTech Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170372
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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