510(k) Report

510(k) · Cleared

Cleared

Zuga Dental Implant System

K171197510(k) TraditionalCleared Jun 30, 2018432-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zuga Medical, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jun 30, 2018 as substantially equivalent to K122664 (Zuga Medical, Inc., 2013) and 11 other predicates after a 432-day review. Its family tree reaches back 12 generations to 1993.

Decided
Jun 30, 2018
Review
432 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
12

Its longest line of descent runs back 12 generations to K925765 (1993). 172 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2011: 1 other ancestor2009: 2 other ancestors2007: 8 other ancestors2005: 5 other ancestors2013: 1 other ancestor2008: 1 other ancestor2006: 6 other ancestors2004: 4 other ancestors2003: 8 other ancestors2002: 10 other ancestors2001: 9 other ancestors1999: 9 other ancestors2000: 4 other ancestors1998: 6 other ancestors1997: 7 other ancestors1996: 12 other ancestors1995: 13 other ancestors1993: 16 other ancestors1990: 8 other ancestors1988: 1 other ancestor1994: 10 other ancestors1992: 4 other ancestors1991: 1 other ancestor1989: 5 other ancestors1987: 2 other ancestors1986: 2 other ancestors1984: 1 other ancestor1982: 1 other ancestor1985: 1 other ancestor1978: 1 other ancestorK925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 1993K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 2002K031475 · Osseotite NT Certain Implants · Implant Innovations, Inc. · 2003K041402 · Modification to Osseotite NT Certain Implants · Implant Innovations, Inc. · 2004×2: 2 generations cleared close together, K051189 (2005), K051461 (2005) ×2: 2 generations cleared close together, K062432 (2007), K062636 (2007) K100724 · Osseotite II Model Xifossxxx · Biomet 3i, Inc. · 2011 · recalledK122664 · Zuga Dental Implant System · Zuga Medical, Inc. · 201319801990200020102020
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 21 other ancestors3 generations back: 43 other ancestors4 generations back: 64 other ancestors5 generations back: 18 other ancestors6 generations back: 1 other ancestor7 generations back: 2 other ancestors8 generations back: 1 other ancestor K122664 · Zuga Dental Implant System · Zuga Medical, Inc. · 2013K100724 · Osseotite II Model Xifossxxx · Biomet 3i, Inc. · 2011 · recalledK062636 · Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental Implants · Implant Innovations, Inc. · 2007K062432 · Nanotite Dental Implants · Implant Innovations, Inc. · 2007K051461 · 3I Osseotite Dental Implants · Implant Innovations, Inc. · 2005K051189 · Prevail Dental Implants · Implant Innovations, Inc. · 2005K041402 · Modification to Osseotite NT Certain Implants · Implant Innovations, Inc. · 2004K031475 · Osseotite NT Certain Implants · Implant Innovations, Inc. · 2003K022009 · 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants · Implant Innovations, Inc. · 2002K014235 · Osseotite NT Dental Implants & Accessories · Implant Innovations, Inc. · 2002K994376 · Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped Cylinder Implant with Frios HA · Friadent GmbH · 2000K925765 · Branemark System Standard 3.75MM Fixture · Nobelpharma USA, Inc. · 1993−10−50
  1. Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
  2. 8 generations between
  3. 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
  4. 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
  5. 1 generation backK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
  6. This deviceK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
Show all 12 generations
  1. Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
  2. 11 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
  3. 10 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
  4. 9 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
  5. 8 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
  6. 7 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
  7. 6 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
  8. 5 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
  9. 4 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
  10. 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
  11. 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
  12. 1 generation backK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
  13. This deviceK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K925765Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc.1993—
−11K994376Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2…Friadent GmbH2000—
−10K014235Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc.2002—
−9K0220093I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc.2002—
−8K031475Osseotite NT Certain ImplantsImplant Innovations, Inc.2003—
−7K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004—
−6K051189Prevail Dental ImplantsImplant Innovations, Inc.2005—
−5K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005—
−4K062432Nanotite Dental ImplantsImplant Innovations, Inc.2007—
−3K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.2007—
−2K100724Osseotite II Model XifossxxxBiomet 3i, Inc.20115
−1K122664Zuga Dental Implant SystemZuga Medical, Inc.2013—
0 (this device)K171197Zuga Dental Implant SystemZuga Medical, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198410
198510
198620
198720
198810
198950
199080
199110
199240
1993160
1994100
1995130
1996120
199770
199860
199990
200040
200190
2002100
200380
200440
200550
200660
200780
200810
200920
201110
201310
201610
FIG. 1 — Lineage of K171197, 1993–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K122664Zuga Dental Implant System
Summary page 7
…eved and with appropriate occlusal loading. Predicate Devices: Zuga™ Dental Implant System – K122664 T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System –…
Zuga Medical, Inc.2013—
*K152787ST Internal Fixture System
Summary page 7
…System – K122664 T-Plus Implant Tech. Co., Ltd. ST Internal Fixture System – K152787 OCO Biomedical Fixed Solid O-Ball Abutment – K090174…
T-Plus Implant Tech. Co., Ltd.2016—
*K090174Tsi; Eri
Summary page 7
…nternal Fixture System – K152787 OCO Biomedical Fixed Solid O-Ball Abutment – K090174 Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570…
Oco Biomedical2009—
*K072570Nobelactive Multi Unit Abutment
Summary page 7
…OCO Biomedical Fixed Solid O-Ball Abutment – K090174 Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570 Reliadent Dental Implant System – K043428, K061323…
Nobel Biocare AB20071
*K043428Reliadent Dental Implant System
Summary page 7
…Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570 Reliadent Dental Implant System – K043428, K061323 Biomet 3i Certain System – K0100724…
Bioinfera, Inc.2005—
*K061323Modification to Reliadent Dental Implant System
Summary page 7
…Nobel Biocare AB NobelActive Multi-Unit Abutment – K072570 Reliadent Dental Implant System – K043428, K061323 Biomet 3i Certain System – K0100724 K…
Bioinfera, Inc.2007—
*K100724Osseotite II Model Xifossxxx
Summary page 7
…K043428, K083544, K070841, 510(k) Number New Device K122664 K100724 K061323 K101201 K071161 Pag…
Biomet 3i, Inc.20115
*K083544Kat Implant System
Summary page 7
…K0100724 KAT Implants System Implants, KAT Implants System Implant Abutment – K083544 KAT Implants System Implants, KAT Implants System Straight…
Kat Implants, LLC2009—
*K101201Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…
Summary page 7
…083544 KAT Implants System Implants, KAT Implants System Straight Abutments – K101201 Southern Implants Endosseous Dental Implant System –…
Kat Implants, LLC2011—
*K070841Endosseous Dental Implant System
Summary page 7
…Abutments – K101201 Southern Implants Endosseous Dental Implant System – K070841, K071161 Technological The fundamental scientific technology of the Zuga™ Characteris…
Southern Implants, Inc.2007—
*K071161Endosseous Dental Implant System
Summary page 7
…ments – K101201 Southern Implants Endosseous Dental Implant System – K070841, K071161 Technological The fundamental scientific technology of the Zuga™ Characteristics:…
Southern Implants, Inc.20072
*K072878Modification to: Locator Implant Anchor
Summary page 13
…movable Denture Abutment Endosseous Dental Implant 510(k) Number New Device K072878 Page 19 The Zuga™ Dental Implant…
Zest Anchors, Inc.20071

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 25 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 20 of the 172 ancestors have a recall of any class.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Zuga Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K122664Zuga Dental Implant SystemZuga Medical, Inc. · 2013

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K171197 · printed Nov 5, 2026

Cite this page

510(k) Report. “K171197: Zuga Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171197

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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