510(k) Report

510(k) · Cleared

Cleared

Ace Surgical Secure-Mini Implant System, Model 09-270X-XX

K073343510(k) TraditionalCleared Mar 13, 2008106-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

Ace Surgical Supply Co., Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 13, 2008 as substantially equivalent to K951392 (Ace Surgical Supply Co., Inc., 1995) and 1 other predicate after a 106-day review. Its family tree reaches back 2 generations to 2002. 135 later devices descend from it.

Decided
Mar 13, 2008
Review
106 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K021045 (2002). 5 ancestors in all, the oldest K951392 (1995). 135 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2009: 1 descendant cleared2013: 2 descendants cleared2012: 1 descendant cleared2010: 1 descendant cleared2021: 13 descendants cleared2014: 4 descendants cleared2015: 4 descendants cleared2022: 14 descendants cleared2020: 12 descendants cleared2024: 14 descendants cleared2018: 6 descendants cleared2016: 2 descendants cleared2019: 8 descendants cleared2025: 23 descendants cleared2017: 1 descendant cleared2023: 17 descendants cleared2026: 12 descendants clearedK021045 · Era Implant · Sterngold · 2002K070601 · Mini Drive-Lock Dental Implant System · Intra-Lock International · 20071995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 11 descendants3 generations forward: 17 descendants4 generations forward: 28 descendants5 generations forward: 28 descendants6 generations forward: 23 descendants7 generations forward: 10 descendants8 generations forward: 8 descendants9 generations forward: 6 descendants10 generations forward: 1 descendant11 generations forward: 1 descendant K070601 · Mini Drive-Lock Dental Implant System · Intra-Lock International · 2007K021045 · Era Implant · Sterngold · 20020+5+10
  1. Root · 2 generations backK021045 Era ImplantSterngold · 2002
  2. 1 generation backK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
  3. This deviceK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  4. Descendant · cites it directly · 134 of its ownK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009
  5. Descendant · cites it directly · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  6. Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  7. Descendant · 2 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  8. Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015

Showing 5 of 135 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 12013: 22014: 42015: 42016: 22017: 12018: 62019: 82020: 122021: 132022: 142023: 172024: 142025: 232026: 12
2009high 23 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 135 · See all
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009 · cites it directly134descendants
  • 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
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 2 generations on109descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K021045Era ImplantSterngold2002—
−1K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007—
0 (this device)K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008—
+1K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc.2009—
+1K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+2K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
201320
201440
201540
201620
201710
201860
201980
2020120
2021130
2022140
2023170
2024140
2025230
2026120
FIG. 1 — Lineage of K073343, 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), 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? (2)

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
*K951392Miniboneplate System
Summary page 1
…ant Screw Classification Name: Implant, Endosseous, Root form, product code DZE Predicate device: ACE Surgical Miniboneplate system, K951392 Intra-Lock International Mini Drive-Lock TM Implant System, K070601 Reason for submission:…
Ace Surgical Supply Co., Inc.1995—
*K070601Mini Drive-Lock Dental Implant System
Summary page 1
…device: ACE Surgical Miniboneplate system, K951392 Intra-Lock International Mini Drive-Lock TM Implant System, K070601 Reason for submission: Not previously marketed in the USA Device Description and Materials: The ACE Surgical Secu…
Intra-Lock International2007—

Also cleared against K951392: 3 other devices →

What descends from it? (135)

See all 135

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

NumberDeviceApplicantDecidedDescendants
K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc.2009134
K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127

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 6 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K092594 (Ace Surgical Supply Co., Inc., 2009) has gone furthest, with 134 descendants of its own.
  • 3 other devices also cite its predicate K951392.

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 ACE Surgical Secure-MiniTM Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.

Indications for use as stated in the FDA summary.

Also cleared against K951392

3 other devices cite the same predicate.

  • K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
  • K062436Sis Sinus Implant StabilizerMondeal Medical Systems GmbH · 2007
  • K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X…Ace Surgical Supply Co., Inc. · 2006

More from Ace Surgical Supply Co., Inc.

21 FDA decisions under this applicant name. See the company

  • K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 20101 recall
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009
  • K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
  • K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X…Ace Surgical Supply Co., Inc. · 2006
  • K051381Ace Surgicalplaster Calcium Sulface HemihydrateAce Surgical Supply Co., Inc. · 20052 recalls

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/K073343 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073343: Ace Surgical Secure-Mini Implant System, Model 09-270X-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073343

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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