510(k) · Cleared
ClearedZuga Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zuga Medical, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 30, 2013 as substantially equivalent to K043428 (Bioinfera, Inc., 2005) and 6 other predicates after a 242-day review. Its family tree reaches back 11 generations to 1993. 1 later device descends from it.
- Decided
- Apr 30, 2013
- Review
- 242 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K925765 (1993). 129 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations between
- 3 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 2 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 1 generation backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- This deviceK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 9 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 8 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 7 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 6 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 5 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 3 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 2 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 1 generation backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- This deviceK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −10 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −9 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −8 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −7 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −6 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −5 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −3 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −2 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −1 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| 0 (this device) | K122664 | Zuga Dental Implant System | Zuga Medical, Inc. | 2013 | — |
| +1 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 8 | 0 |
| 1992 | 4 | 0 |
| 1993 | 11 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (7)
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 |
|---|---|---|---|
| * | K043428 | Reliadent Dental Implant SystemSummary page 1…ation screw is manufactured from titanium alloy (Ti-6A1-4V) as described by ASTM F1 36. Predicate Devices: Reliadent Dental Imnplant System (K043428 and K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201… | 2005 |
| * | K061323 | Modification to Reliadent Dental Implant SystemSummary page 1…is manufactured from titanium alloy (Ti-6A1-4V) as described by ASTM F1 36. Predicate Devices: Reliadent Dental Imnplant System (K043428 and K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201)… | 2007 |
| * | K100724 | Osseotite II Model XifossxxxSummary page 1…Ti-6A1-4V) as described by ASTM F1 36. Predicate Devices: Reliadent Dental Imnplant System (K043428 and K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071 161)… | 2011 |
| * | K083544 | Kat Implant SystemSummary page 1…ate Devices: Reliadent Dental Imnplant System (K043428 and K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071 161)… | 2009 |
| * | K101201 | Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Summary page 1…Reliadent Dental Imnplant System (K043428 and K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071 161)… | 2011 |
| * | K070841 | Endosseous Dental Implant SystemSummary page 1…K061323) Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071 161) Page 9 Technolog… | 2007 |
| * | K071161 | Endosseous Dental Implant SystemSummary page 1…Biomet 3i Certain®@ System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071 161) Page 9 Technological… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171197 | Zuga Dental Implant System | 2018 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 14 of the 129 ancestors have a recall of any class.
- Of its descendants, K171197 (Zuga Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043428.
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 Zuga Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122664: Zuga 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/K122664
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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