510(k) · Cleared
ClearedReplus Dental Implants (HA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Mar 7, 2008 as substantially equivalent to K013227 (Sulzer Dental, Inc., 2001) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 1990. 43 later devices descend from it.
- Decided
- Mar 7, 2008
- Review
- 119 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894595 (1990). 14 ancestors in all. 43 later devices descend from it, 2 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 backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- This deviceK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- Descendant · cites it directly · 23 of its ownK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- Descendant · 2 generations on · 22 of its ownK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
- Descendant · cites it directly · 18 of its ownK101225 Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001…Promimic AB · 2011
- Descendant · 2 generations on · 16 of its ownK170392 S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017
- Descendant · 3 generations on · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K080713Reactive Dental Implant SystemImplant Direct, LLC · 2008 · cites it directly23descendants
- K090234Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · 2 generations on22descendants
- K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB · 2011 · cites it directly18descendants
- K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A. · 2017 · 2 generations on16descendants
- K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · 3 generations on10descendants
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 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| 0 (this device) | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| +1 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| +2 | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | 11 |
| +1 | K101225 | Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental… | Promimic AB | 2011 | — |
| +2 | K170392 | S.I.N. Implant System | S.I.N. – Sistema DE Implante Nacional S.A. | 2017 | — |
| +3 | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…us Dental Implant 2. Device Trade Name: RePlus Dental Implants With HA Coating 3. Predicate Device(s): Zimmer Dental Tapered Screw-Vent Dental Implants (K013227), Nobel Biocare Tapered Groovy Implants (K29352) and Implant Direct's Spectra-System (K061319) 4. Device Description:… | 2001 |
| Kept off the family tree | K029352 | Nobel Biocare Tapered Groovy Implants Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K061319 | Spectra SystemSummary page 1…Device(s): Zimmer Dental Tapered Screw-Vent Dental Implants (K013227), Nobel Biocare Tapered Groovy Implants (K29352) and Implant Direct's Spectra-System (K061319) 4. Device Description: The RePlus Implant system consists of tapered screw-type endosseous implants with the sa… | 2006 |
What descends from it? (43)
See all 432 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 18 years and passes through 5 companies; a new generation was cleared every 6.3 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K080713 (Implant Direct, LLC, 2008) has gone furthest, with 23 descendants of its own.
- 14 other devices also cite its predicate K013227.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The RePlus Dental Implants with HA coating are dental implant fixtures that are a
part of a two-piece implant system. The RePlus implants are intended for use in
the mandible and maxilla, in support of single or multiple-unit cement or screw
receiving fixed restorations and for retention and support of overdentures. The
implants are intended for immediate loading for support of single tooth and/or
multiple tooth restorations, provided initial implant stability and appropriate
occlusal load requirements are met.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073161: Replus Dental Implants (HA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073161
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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