510(k) · Cleared
Recalled · Class II · 2015Nobelreplace Tapered Conical Connection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare USA, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Dec 6, 2006 as substantially equivalent to K050258 (Nobel Biocare AB, 2005) and 1 other predicate after a 97-day review. Its family tree reaches back 7 generations to 1990. 109 later devices descend from it. It has been recalled 27 times.
- Decided
- Dec 6, 2006
- Review
- 97 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 27
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894595 (1990). 21 ancestors in all. 109 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 3 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 2 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 1 generation backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- This deviceK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006
- Descendant · cites it directly · 95 of its ownK073142 Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · Recalled
- Descendant · cites it directly · 94 of its ownK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 88 of its ownK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K073142Nobelreplace Hexagonal ImplantNobel Biocare USA, LLC · 2008 · cites it directly95descendants
- K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · cites it directly94descendants
- K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · 2 generations on88descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −3 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −1 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| 0 (this device) | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | — |
| +1 | K073142 | Nobelreplace Hexagonal Implant | Nobel Biocare USA, LLC | 2008 | 2 |
| +1 | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | Zimmer Dental, Inc. | 2010 | 1 |
| +2 | K112160 | Tapered Screw-Vent X Implant | Zimmer Dental, Inc. | 2011 | 19 |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 22 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K050258 | Groovy ImplantsSummary page 1…2.3640) Trade or Proprietary or Model Name: NobelReplace Tapered Conical Connection Legally Marketed Device(s): Groovy Implants (K050258) SFB & CFB Implants (K061003) Device Description: Nobel Biocare's NobelReplace Tapered… | 2005 |
| * | K061003 | SFB & CFB ImplantsSummary page 1…NobelReplace Tapered Conical Connection Legally Marketed Device(s): Groovy Implants (K050258) SFB & CFB Implants (K061003) Device Description: Nobel Biocare's NobelReplace Tapered Conical Connection implants are threaded, root-form dental implants i… | 2006 |
What descends from it? (109)
See all 1095 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073142 | Nobelreplace Hexagonal Implant | 2008 | 95 |
| K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | 2010 | 94 |
| K143051 | ArgenIS Titanium Abutments | 2015 | 2 |
| K130694 | JR Implant System | 2014 | 0 |
| K120530 | Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2015 | Class II | Z-1432-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1419-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1437-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1416-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1425-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1427-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1438-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1440-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1431-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.. |
| Mar 9, 2015 | Class II | Z-1426-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1421-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1415-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1436-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1417-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1439-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1429-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1424-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1435-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1422-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1418-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1414-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1428-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1430-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1420-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1423-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1434-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
| Mar 9, 2015 | Class II | Z-1433-2015 | Nonconforming Material/Component | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K073142 (Nobel Biocare USA, LLC, 2008) has gone furthest, with 95 descendants of its own.
- 7 other devices also cite its predicate K050258.
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's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection…
Read the full statement (100 words)
Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or non-splinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062566: Nobelreplace Tapered Conical Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062566
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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