510(k) Report

510(k) · Cleared

Cleared

Mini Drive-Lock Dental Implant System

K070601510(k) TraditionalCleared Oct 12, 2007224-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

Intra-Lock International · DZE Implant, Endosseous, Root-Form

Cleared on Oct 12, 2007 as substantially equivalent to K040143 (Nats Corp., 2004) and 2 other predicates after a 224-day review. Its family tree reaches back 1 generation to 2002. 144 later devices descend from it.

Decided
Oct 12, 2007
Review
224 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K021045 (2002). 3 ancestors in all. 144 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2012: 3 descendants cleared2014: 5 descendants cleared2008: 2 descendants cleared2009: 4 descendants cleared2013: 3 descendants cleared2021: 13 descendants cleared2015: 4 descendants cleared2022: 14 descendants cleared2010: 1 descendant 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 · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 11 descendants3 generations forward: 18 descendants4 generations forward: 30 descendants5 generations forward: 29 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 K021045 · Era Implant · Sterngold · 20020+5+10
  1. Root · 1 generation backK021045 Era ImplantSterngold · 2002
  2. This deviceK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
  3. Descendant · cites it directly · 135 of its ownK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  4. Descendant · 2 generations on · 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

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

2008: 22009: 42010: 12012: 32013: 32014: 52015: 42016: 22017: 12018: 62019: 82020: 122021: 132022: 142023: 172024: 142025: 232026: 12
2008high 23 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 144 · See all
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008 · cites it directly135descendants
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009 · 2 generations on134descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021045Era ImplantSterngold2002—
0 (this device)K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International2007—
+1K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008—
+2K092594Ace 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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200940
201010
201230
201330
201450
201540
201620
201710
201860
201980
2020120
2021130
2022140
2023170
2024140
2025230
2026120
FIG. 1 — Lineage of K070601, 2002–2026Source: 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 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? (3)

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
*K040143Monorail
Summary page 1
…icate Devices: Product Name Company 510(k) Dentatus Monorail" NATS Corporation K040143 ERA" Implant Sterngold K021045 Imtec Sendax~MVDI and MVDI lmtec Corpo…
Nats Corp.2004—
*K021045Era Implant
Summary page 1
…510(k) Dentatus Monorail" NATS Corporation K040143 ERA" Implant Sterngold K021045 Imtec Sendax~MVDI and MVDI lmtec Corporation K031106 Plus Device Description: The Int…
Sterngold2002—
*K031106Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX
Summary page 1
…K040143 ERA" Implant Sterngold K021045 Imtec Sendax~MVDI and MVDI lmtec Corporation K031106 Plus Device Description: The Intra-Lock Mini Drive-Lock Tm Dental Implant System consists of…
Imtec Corp.20031

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008135
K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127
K073645Simpler Mini Dental Implant: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM659543 BC, Ltd.20083
K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121
K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140
K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120
K083669OBIEuroteknika20090

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K073343 (Ace Surgical Supply Co., Inc., 2008) has gone furthest, with 135 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. 2007, 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?

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications.

Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

Indications for use as stated in the FDA summary.

More from Intra-Lock International

8 FDA decisions under this applicant name. See the company

  • K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013
  • K080598Mini Drive-Lock Dental Implant System ProstheticsIntra-Lock International · 2008
  • K050970Milo Dental Implant SystemIntra-Lock International · 2005
  • K040205Intra-Lock International Angled Prosthetic AbutmentsIntra-Lock International · 2004
  • K031322Intra-Lock Hydroxyapatite Coated ImplantsIntra-Lock International · 2003

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/K070601 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070601: Mini Drive-Lock Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070601

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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