510(k) · Cleared
Recalled · Class II · 2019Nobelactive Internal Connection Implant
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 Aug 3, 2007 as substantially equivalent to K061003 (Nobel Biocare AB, 2006) after a 79-day review. Its family tree reaches back 7 generations to 1990. 414 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 3, 2007
- Review
- 79 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894595 (1990). 21 ancestors in all. 414 later devices descend from it, 29 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 deviceK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007
- Descendant · cites it directly · 214 of its ownK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · cites it directly · 203 of its ownK102436 Nobel Active 3.0Nobel Biocare AB · 2010
- Descendant · 2 generations on · 201 of its ownK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- Descendant · 3 generations on · 200 of its ownK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
Showing 5 of 414 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 414 · See all- K101732Astra Tech Implant SystemAstra Tech AB · 2011 · cites it directly214descendants
- K102436Nobel Active 3.0Nobel Biocare AB · 2010 · cites it directly203descendants
- K111287Astra Tech Implant SystemAstra Tech AB · 2011 · 2 generations on201descendants
- K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011 · 3 generations on200descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
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) | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | — |
| +1 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| +1 | K102436 | Nobel Active 3.0 | Nobel Biocare AB | 2010 | — |
| +2 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| +3 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
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 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 18 | 0 |
| 2014 | 15 | 0 |
| 2015 | 23 | 0 |
| 2016 | 20 | 0 |
| 2017 | 22 | 0 |
| 2018 | 20 | 0 |
| 2019 | 23 | 0 |
| 2020 | 28 | 0 |
| 2021 | 32 | 0 |
| 2022 | 33 | 0 |
| 2023 | 35 | 0 |
| 2024 | 50 | 0 |
| 2025 | 45 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K061003 | SFB & CFB ImplantsSummary page 1…2.3640) Trade or Proprietary or Model Name: NobelActive Internal Connection Implant Legally Marketed Device(s): SFB & CFB Implants (K061003) Device Description: NobelActive Internal Connection Implants are threaded, root-form dental implants intended for use in the u… | 2006 |
What descends from it? (414)
See all 41429 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101732 | Astra Tech Implant System | 2011 | 214 |
| K102436 | Nobel Active 3.0 | 2010 | 203 |
| K140878 | Straumann Bone Level Tapered Implant | 2014 | 105 |
| K083205 | Nobelactive 8.5 MM & 18.0 MM | 2009 | 103 |
| K133731 | Nobelactive Wide Platform (WP) | 2014 | 101 |
| K142260 | NobelActive | 2015 | 99 |
| K093483 | Atlantis Abutment for Nobel Biocare Active Implant, Atlantis Gemini Abutment, Gemini +… | 2009 | 67 |
| K083192 | Inclusive Titanium Abutment Blanks | 2009 | 40 |
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K111003 | Biodenta Dental Implant System - Bone Level | 2011 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2019 | Class II | Z-1855-2020 | Process control | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. |
| Aug 9, 2019 | Class II | Z-1854-2020 | Process control | Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw. |
| Jul 19, 2019 | Class II | Z-2207-2020 | Labeling mix-ups | The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause… |
| May 28, 2019 | Class II | Z-2250-2020 | Labeling mix-ups | Packaged dental implant healing abutments were found to contain the wrong size device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 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, K101732 (Astra Tech AB, 2011) has gone furthest, with 214 descendants of its own.
- 6 other devices also cite its predicate K061003.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Nobel Biocare's NobelActive implants are endosseous implant 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 NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants 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/K071370 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071370: Nobelactive Internal Connection Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071370
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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