510(k) · Cleared
ClearedNobelspeedy Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Jun 8, 2005 as substantially equivalent to K041661 (Nobel Biocare Uas, Inc., 2004) after a 111-day review. Its family tree reaches back 5 generations to 1990. 234 later devices descend from it.
- Decided
- Jun 8, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894595 (1990). 18 ancestors in all. 234 later devices descend from it, 16 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 1 generation backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- This deviceK050406 Nobelspeedy ImplantsNobel Biocare AB · 2005
- Descendant · cites it directly · 181 of its ownK101207 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010
- Descendant · cites it directly · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011
- Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · 2 generations on · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
Showing 5 of 234 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 234 · See all- K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2010 · cites it directly181descendants
- K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly180descendants
- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 2 generations on123descendants
- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · 2 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −1 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K050406 | Nobelspeedy Implants | Nobel Biocare AB | 2005 | — |
| +1 | K101207 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2010 | — |
| +1 | K101945 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2011 | — |
| +2 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +2 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +2 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 11 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 11 | 0 |
| 2018 | 9 | 0 |
| 2019 | 14 | 0 |
| 2020 | 20 | 0 |
| 2021 | 22 | 0 |
| 2022 | 20 | 0 |
| 2023 | 25 | 0 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K041661 | Nobel Biocare Endosseous ImplantsSummary page 1….3640) Trade or Proprietary or Model Name: NOBELSPEEDyT Implants Legally Marketed Device(s): Nobel Biocare Endosseous Implants (K041661) Device Description: Nobel Biocare's NOBELSPEEDY TM Implants are threaded, root-form dental implants intended for use in the upp… | 2004 |
What descends from it? (234)
See all 23416 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101207 | Neodent Implant System | 2010 | 181 |
| K101945 | Neodent Implant System | 2011 | 180 |
| K140878 | Straumann Bone Level Tapered Implant | 2014 | 105 |
| K133731 | Nobelactive Wide Platform (WP) | 2014 | 101 |
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | 2011 | 30 |
| K160119 | NobelSpeedy Groovy | 2016 | 7 |
| K222231 | S.I.N. Dental Implant System | 2022 | 4 |
| K131066 | Axiom Reg | 2014 | 2 |
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 15 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K101207 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2010) has gone furthest, with 181 descendants of its own.
- 7 other devices also cite its predicate K041661.
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?
NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY Implants may be placed…
Read the full statement (219 words)
NOBELSPEEDY™ Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELSPEEDY Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare NOBELSPEEDY Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELSPEEDY™ Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY™ Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY™ Implants are preferred in these soft bone indications because bone formation on the TiUnite® surface is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
NOBELSPEEDY™ Implants may be tilted up to 45°. When used with angulations between 30° and 45° a minimum of four implants must be used and splinted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050406: Nobelspeedy Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050406
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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