510(k) Report

510(k) · Cleared

Cleared

Mini Drive-Lock Dental Implant System Prosthetics

K080598510(k) AbbreviatedCleared May 21, 200879-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intra-Lock International · NHA Abutment, Implant, Dental, Endosseous

Cleared on May 21, 2008 after a 79-day review. The FDA summary names its predicate without a number. 128 later devices descend from it.

Decided
May 21, 2008
Review
79 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

128 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2021: 12 descendants cleared2014: 3 descendants cleared2015: 4 descendants cleared2022: 14 descendants cleared2020: 11 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 cleared20052010201520202025
  1. This deviceK080598 Mini Drive-Lock Dental Implant System ProstheticsIntra-Lock International · 2008
  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 · 2 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  5. Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
  6. Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

2013: 12014: 32015: 42016: 22017: 12018: 62019: 82020: 112021: 122022: 142023: 172024: 142025: 232026: 12
2013high 23 (2025) · low 1 (2013)2026

Most influential descendants

Showing 5 of 128 · 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
  • 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
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080598Mini Drive-Lock Dental Implant System ProstheticsIntra-Lock International2008—
+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—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201430
201540
201620
201710
201860
201980
2020110
2021120
2022140
2023170
2024140
2025230
2026120
FIG. 1 — Lineage of K080598, 2008–2026Source: 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 NHA? 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 NHA device

  1. #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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? (1)

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
*—Intra-Lock Dental Implant Systems
Named without a submission number
—

What descends from it? (128)

See all 128

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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?

  • 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 NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

The Intra-Lock Mini Drive Lock Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

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
  • K070601Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
  • 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 NHA

The NHA category page

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  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K080598 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080598: Mini Drive-Lock Dental Implant System Prosthetics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080598

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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