510(k) · Cleared
ClearedAvinent Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avinent Implant System S.L. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 11, 2013 as substantially equivalent to K073268 (BioHorizons Implant Systems, Inc., 2008) and 3 other predicates after a 532-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Dec 11, 2013
- Review
- 532 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K960026 (1996). 36 ancestors in all, the oldest K894595 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 5 generations between
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- 1 generation backK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
- This deviceK121873 Avinent Dental Implant SystemAvinent Implant System S.L. · 2013
Show all 9 generations
- Root · 9 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 7 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 6 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 3 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 2 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
- 1 generation backK073268 Biohorizons Internal Implant SystemBioHorizons Implant Systems, Inc. · 2008 · Recalled
- This deviceK121873 Avinent Dental Implant SystemAvinent Implant System S.L. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −8 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −6 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −3 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −2 | K042429 | The Prodigy System Dental Implants | BioHorizons Implant Systems, Inc. | 2004 | — |
| −1 | K073268 | Biohorizons Internal Implant System | BioHorizons Implant Systems, Inc. | 2008 | 1 |
| 0 (this device) | K121873 | Avinent Dental Implant System | Avinent Implant System S.L. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K073268 | Biohorizons Internal Implant SystemSummary page 1…Root-form Endosseous Dental Implant CLASSIFICATION NAME: Root-form Endosseous Dental Implant (21 CFR 872.3640) PREDICATE DEVICE(S): Blohorizons (K073268) NobetActive 3.0 (K1 02436) Nobel Biacare Endosseous Implants (K041… | 2008 |
| * | K102436 | Nobel Active 3.0Summary page 1…ME: Root-form Endosseous Dental Implant (21 CFR 872.3640) PREDICATE DEVICE(S): Blohorizons (K073268) NobetActive 3.0 (K1 02436) Nobel Biacare Endosseous Implants (K041661) NobelSpeedy (K050406)… | 2010 |
| * | K041661 | Nobel Biocare Endosseous Implants Our reading of the summary gave K041681, FDA’s number for Atricure Dissector (AtriCure, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nobel Biocare Endosseous Implants”. | 2004 |
| * | K050406 | Nobelspeedy ImplantsSummary page 1…NobetActive 3.0 (K1 02436) Nobel Biacare Endosseous Implants (K041661) NobelSpeedy (K050406) DEVICE DESCRIPTION: The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corre… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 8 of the 36 ancestors have a recall of any class.
- 7 other devices also cite its predicate K073268.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with…
Read the full statement (119 words)
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.
Specific indications for small diameter (03.3 mm implants):
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary incisors or mandibular central and lateral incisors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121873: Avinent Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121873
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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