510(k) Report

510(k) · Cleared

Cleared

Uniplant Dental Implant System

K011574510(k) TraditionalCleared Sep 28, 2001129-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

Universal Implant Systems, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 28, 2001 as substantially equivalent to K923889 (O Co., Inc., 1994) and 8 other predicates after a 129-day review. Its family tree reaches back 2 generations to 1991.

Decided
Sep 28, 2001
Review
129 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K900179 (1991). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 5 other ancestors1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK900179 · Screw-Vent Endosseous Implant Abutments · Core-Vent Corp. · 1991K961665 · O Butment ET Implant · O Co., Inc. · 19961990199219941996199820002002
Other ancestors, by generation 1 generation back: 8 other ancestors K961665 · O Butment ET Implant · O Co., Inc. · 1996K900179 · Screw-Vent Endosseous Implant Abutments · Core-Vent Corp. · 19910
  1. Root · 2 generations backK900179 Screw-Vent Endosseous Implant AbutmentsCore-Vent Corp. · 1991
  2. 1 generation backK961665 O Butment ET ImplantO Co., Inc. · 1996
  3. This deviceK011574 Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K900179Screw-Vent Endosseous Implant AbutmentsCore-Vent Corp.1991—
−1K961665O Butment ET ImplantO Co., Inc.1996—
0 (this device)K011574Uniplant Dental Implant SystemUniversal Implant Systems, Inc.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199850
FIG. 1 — Lineage of K011574, 1991–2001Source: 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
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What was it cleared against? (9)

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
*K923889O Butment ES Implant
Summary page 3
…redicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: “O” Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402,…
O Co., Inc.1994—
*K950066Dental Implant Endosseous
Summary page 3
…devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: “O” Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856,…
O Co., Inc.1995—
*K961665O Butment ET Implant
Summary page 3
…each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: “O” Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857)…
O Co., Inc.1996—
*K973926O Butment HS Implant
Summary page 3
…hich has been determined by FDA to be substantially equivalent to pre-amendment devices: “O” Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intend…
O Co., Inc.1998—
*K962845Replace HA Coated Implants
Summary page 3
…equivalent to pre-amendment devices: “O” Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intended Uses The indications for use for the Uniplant D…
Steri-Oss, Inc.1996—
*K9744014.0MM Simpler One Threaded Dental Implant
Summary page 3
…Company Threaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intended Uses The indications for use for the Uniplant Dental Implant System and the predicate dev…
Vancouver Implant Resources, Inc.1998—
*K9744023.25 MM Simpler One Threaded Dental Implant
Summary page 3
…hreaded Implants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intended Uses The indications for use for the Uniplant Dental Implant System and the predicate devices are…
Vancouver Implant Resources, Inc.1998—
*K9748563.25MM Simpler Threaded Dental Implant
Summary page 3
…mplants and Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intended Uses The indications for use for the Uniplant Dental Implant System and the predicate devices are substanti…
Vancouver Implant Resources, Inc.1998—
*K9748574.0MM Simpler Threaded Dental Implant
Summary page 3
…nd Fixed C&B Abutment (K923889, K950066, K961665, K973926), the Steri-Oss Replace HA-Coated Implant (K962845), and the Simpler Implant System (K974401, K974402, K974856, K974857). Intended Uses The indications for use for the Uniplant Dental Implant System and the predicate devices are substantially the…
Vancouver Implant Resources, Inc.1998—

Also cleared against K923889: 2 other devices →

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 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
  • None of the 10 ancestors has a recall.
  • 2 other devices also cite its predicate K923889.

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.

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?

Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

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

Also cleared against K923889

2 other devices cite the same predicate.

  • K973926O Butment HS ImplantO Co., Inc. · 1998
  • K961665O Butment ET ImplantO Co., Inc. · 1996

More from Universal Implant Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K905223Octa-Hex (TM) Implant Restoration SystemsUniversal Implant Systems, Inc. · 1991

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/K011574 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011574: Uniplant 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/K011574

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026