510(k) Report

510(k) · Cleared

Cleared

6.0 X 5.7MM Dental Implant

K010185510(k) TraditionalCleared Dec 30, 2002710-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, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Dec 30, 2002 after a 710-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 234 later devices descend from it.

Decided
Dec 30, 2002
Review
710 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

234 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2013: 8 descendants cleared2008: 3 descendants cleared2011: 3 descendants cleared2012: 6 descendants cleared2010: 3 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2007: 2 descendants cleared2009: 3 descendants cleared2017: 5 descendants cleared2022: 23 descendants cleared2021: 21 descendants cleared2014: 5 descendants cleared2015: 4 descendants cleared2016: 4 descendants cleared2023: 27 descendants cleared2018: 13 descendants cleared2019: 14 descendants cleared2020: 22 descendants cleared2024: 25 descendants cleared2025: 28 descendants cleared2026: 13 descendants cleared200020052010201520202025
  1. This deviceK010185 6.0 X 5.7MM Dental ImplantBicon, Inc. · 2002
  2. Descendant · cites it directly · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  3. Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  4. Descendant · cites it directly · 118 of its ownK053353 Rescue Implant SystemMegagen Co., Ltd. · 2006
  5. Descendant · 2 generations on · 112 of its ownK063216 Rescue Internal Implant SystemMegagen Co., Ltd. · 2007
  6. Descendant · 2 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014

Showing 5 of 234 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22008: 32009: 32010: 32011: 32012: 62013: 82014: 52015: 42016: 42017: 52018: 132019: 142020: 222021: 212022: 232023: 272024: 252025: 282026: 13
2005high 28 (2025) · low 1 (2005)2026

Most influential descendants

Showing 5 of 234 · See all
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · cites it directly127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 2 generations on123descendants
  • K053353Rescue Implant SystemMegagen Co., Ltd. · 2006 · cites it directly118descendants
  • K063216Rescue Internal Implant SystemMegagen Co., Ltd. · 2007 · 2 generations on112descendants
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 2 generations on109descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0101856.0 X 5.7MM Dental ImplantBicon, Inc.2002—
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+1K053353Rescue Implant SystemMegagen Co., Ltd.2006—
+2K063216Rescue Internal Implant SystemMegagen Co., Ltd.2007—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200720
200830
200930
201030
201130
201260
201380
201450
201540
201640
201750
2018130
2019140
2020220
2021210
2022230
2023270
2024250
2025280
2026130
FIG. 1 — Lineage of K010185, 2002–2026Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (234)

See all 234

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

NumberDeviceApplicantDecidedDescendants
K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127
K053353Rescue Implant SystemMegagen Co., Ltd.2006118
K073058Rescue Internal Implant SystemMegagen Co., Ltd.200896
K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121
K103810KJ Submerged SystemKj Meditech Co., Ltd.20111
K093615Spi Dental Implant, ElementThommen Medical AG20101
K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130
K042971Titan Dental Implant SystemTitan Implants, Inc.20050

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, K123022 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2013) has gone furthest, with 127 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.

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—

More from Bicon, Inc.

13 FDA decisions under this applicant name. See the company

  • K062044The 5.0 X 6.0MM Dental ImplantBicon, Inc. · 2006
  • K051091SynthograftBicon, Inc. · 2005
  • K0507124.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental ImplantBicon, Inc. · 2005
  • K050408Bicon Orthodontic Implant SystemBicon, Inc. · 2005
  • K031568Biconite Surface TreatmentBicon, Inc. · 2004

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/K010185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010185: 6.0 X 5.7MM Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010185

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026