510(k) Report

510(k) · Cleared

Cleared

5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant

K073368510(k) TraditionalCleared Oct 10, 2008315-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

Bicon, LLC · DZE Implant, Endosseous, Root-Form

Cleared on Oct 10, 2008 after a 315-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided
Oct 10, 2008
Review
315 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

17 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 3 descendants cleared2015: 2 descendants cleared2011: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2023: 4 descendants cleared20052010201520202025
  1. This deviceK073368 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantBicon, LLC · 2008
  2. Descendant · cites it directly · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
  4. Descendant · 3 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
  5. Descendant · 4 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
  6. Descendant · 4 generations on · 1 of its ownK191458 Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2011: 12013: 32015: 22016: 12018: 12019: 12020: 12021: 12022: 12023: 42024: 1
2011high 4 (2023) · low 0 (2012)2026

Most influential descendants

Showing 5 of 17 · See all
  • K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · cites it directly10descendants
  • K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · 2 generations on8descendants
  • K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 3 generations on6descendants
  • K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 4 generations on3descendants
  • K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2019 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0733685.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantBicon, LLC2008—
+1K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC20134
+2K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC2015—
+3K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2018—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.2020—
+4K191458Legacy SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201330
201520
201610
201810
201910
202010
202110
202210
202340
202410
FIG. 1 — Lineage of K073368, 2008–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (17)

See all 17

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC201310
K1505713i T3 Short ImplantsBiomet 3i20151
K103810KJ Submerged SystemKj Meditech Co., Ltd.20111
K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130
K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130

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?

  • Of its descendants, K130572 (Implant Direct Sybron Manufacturing, LLC, 2013) has gone furthest, with 10 descendants of its own.

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. 2008, 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 5.0 x 5.0mm and the 6.0 x 5.0mm implants are designed as a one stage or two stage surgical procedure implant for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement

Indications for use as stated in the FDA 510(k) statement.

More from Bicon, LLC

5 FDA decisions under this applicant name. See the company

  • K143524Fiber Disks and Blocks (TRINIA)Bicon, LLC · 2015
  • K133608TriniaBicon, LLC · 2014
  • K101849Bicon Dental Implant System 3.0MM Bicon Dental ImplantBicon, LLC · 2010
  • K092035Bicon Implants with a 2.5MM Internal ConnectionBicon, LLC · 2009

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/K073368 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073368

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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