510(k) · Cleared
ClearedNobel Biocare Endosseous Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 26, 2004 as substantially equivalent to K022424 (Nobel Biocare Uas, Inc., 2002) and 2 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1990. 622 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894595 (1990). 17 ancestors in all. 622 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 1 generation backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- This deviceK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- Descendant · cites it directly · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · cites it directly · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 2 generations on · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- Descendant · 3 generations on · 414 of its ownK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- Descendant · 3 generations on · 327 of its ownK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
Showing 5 of 622 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 622 · See all- K050705Tiunite ImplantsNobel Biocare AB · 2005 · cites it directly532descendants
- K050258Groovy ImplantsNobel Biocare AB · 2005 · cites it directly511descendants
- K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · 2 generations on507descendants
- K071370Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · 3 generations on414descendants
- K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB · 2006 · 3 generations on327descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −1 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| 0 (this device) | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| +1 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| +1 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| +2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| +3 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| +3 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
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 |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 13 | 0 |
| 2011 | 17 | 0 |
| 2012 | 13 | 0 |
| 2013 | 26 | 0 |
| 2014 | 30 | 0 |
| 2015 | 35 | 0 |
| 2016 | 32 | 0 |
| 2017 | 29 | 0 |
| 2018 | 30 | 0 |
| 2019 | 34 | 0 |
| 2020 | 47 | 0 |
| 2021 | 44 | 0 |
| 2022 | 42 | 0 |
| 2023 | 54 | 0 |
| 2024 | 63 | 0 |
| 2025 | 54 | 0 |
| 2026 | 27 | 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? (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 | Decided |
|---|---|---|---|
| * | K022424 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Summary page 1…640) Trade or Proprietary or Model Name: Nobel Biocare Endosseous Implants Legally Marketed Device(s): Replace HA Coated Implants (K022424) Brinemark System Implants (K022562) Replace Ti… | 2002 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…are Endosseous Implants Legally Marketed Device(s): Replace HA Coated Implants (K022424) Brinemark System Implants (K022562) Replace TiUnite Endosseous Implants (K023113) Device Description: Nobel Biocare Endo… | 2002 |
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…ants (K022424) Brinemark System Implants (K022562) Replace TiUnite Endosseous Implants (K023113) Device Description: Nobel Biocare Endosseous Implants are threaded, root-form dental implants intended for use in the upper a… | 2002 |
What descends from it? (622)
See all 6228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050705 | Tiunite Implants | 2005 | 532 |
| K050258 | Groovy Implants | 2005 | 511 |
| K050406 | Nobelspeedy Implants | 2005 | 234 |
| K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | 2011 | 30 |
| K132881 | Z5C | 2014 | 8 |
| K073458 | BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2) | 2008 | 2 |
| K040757 | Sic Pro | 2005 | 2 |
| K121873 | Avinent Dental Implant System | 2013 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K050705 (Nobel Biocare AB, 2005) has gone furthest, with 532 descendants of its own.
- 1 other device also cites its predicate K022424.
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?
Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 450 . When used with angulations between 300 and 450, the following applies:
• the tilted implants must be splinted
• a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041661: Nobel Biocare Endosseous Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041661
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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