510(k) · Cleared
ClearedReplace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
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 May 29, 2002 as substantially equivalent to K962845 (Steri-Oss, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993. 630 later devices descend from it.
- Decided
- May 29, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911592 (1993). 3 ancestors in all. 630 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK911592 Steri-Oss Titanium Plama Spray Cylindrical ImplantSteri-Oss, Inc. · 1993
- 1 generation backK973423 Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSteri-Oss, Inc. · 1997
- This deviceK020646 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
- Descendant · cites it directly · 625 of its ownK022424 Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132…Nobel Biocare Uas, Inc. · 2002
- Descendant · 2 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- Descendant · 3 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 3 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 4 generations on · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
Showing 5 of 630 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 630 · See all- K022424Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102…Nobel Biocare Uas, Inc. · 2002 · cites it directly625descendants
- K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 2 generations on622descendants
- K050705Tiunite ImplantsNobel Biocare AB · 2005 · 3 generations on532descendants
- K050258Groovy ImplantsNobel Biocare AB · 2005 · 3 generations on511descendants
- K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · 4 generations on507descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911592 | Steri-Oss Titanium Plama Spray Cylindrical Implant | Steri-Oss, Inc. | 1993 | — |
| −1 | K973423 | Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental Implant | Steri-Oss, Inc. | 1997 | — |
| 0 (this device) | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… | Nobel Biocare Uas, Inc. | 2002 | — |
| +1 | K022424 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… | Nobel Biocare Uas, Inc. | 2002 | — |
| +2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| +3 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| +3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| +4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 13 | 0 |
| 2011 | 18 | 0 |
| 2012 | 15 | 0 |
| 2013 | 26 | 0 |
| 2014 | 30 | 0 |
| 2015 | 35 | 0 |
| 2016 | 33 | 0 |
| 2017 | 29 | 0 |
| 2018 | 31 | 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? (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 |
|---|---|---|---|
| * | K962845 | Replace HA Coated ImplantsSummary page 1…87 USA Phone: 1-800-993-8100, ext 5074 Fax: 1-714-998-9348 Vincent Cheung Manager, Regulatory Affairs & Quality Assurance (714) 282-5074 . Replace™ HA Coated Implant (K962845) Steri-Oss 3.25 mm Replace™ HA Coated Implant (K973423) Endosseous Dental Implant (21 CFR 872.3640) Class I The information su… | 1996 |
| * | K973423 | Steri-Oss 3.25 MM Replace (Hydroxyapatite-Coated)Dental ImplantSummary page 1…9348 Vincent Cheung Manager, Regulatory Affairs & Quality Assurance (714) 282-5074 . Replace™ HA Coated Implant (K962845) Steri-Oss 3.25 mm Replace™ HA Coated Implant (K973423) Endosseous Dental Implant (21 CFR 872.3640) Class I The information supporting claims of substantial equivalence, as defined… | 1997 |
What descends from it? (630)
See all 6304 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 9 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022424 (Nobel Biocare Uas, Inc., 2002) has gone furthest, with 625 descendants of its own.
- 3 other devices also cite its predicate K962845.
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?
The Replace” HA Coated Implant is for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type Il bone), to restore chewing function.
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/K020646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020646
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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