510(k) Report

510(k) · Cleared

Cleared

Intra-Lock Hydroxyapatite Coated Implants

K031322510(k) AbbreviatedCleared Dec 23, 2003242-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 Dec 23, 2003 as substantially equivalent to K021244 (Ace Surgical Supply Co., Inc., 2002) and 5 other predicates after a 242-day review. Its family tree reaches back 1 generation to 1996.

Decided
Dec 23, 2003
Review
242 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K960288 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestorK960288 · HA & TPS Restore Self Tapping Dental Implant System · Lifecore Biomedical, Inc. · 199619961998200020022004
Other ancestors, by generation 1 generation back: 5 other ancestors K960288 · HA & TPS Restore Self Tapping Dental Implant System · Lifecore Biomedical, Inc. · 19960
  1. Root · 1 generation backK960288 HA & TPS Restore Self Tapping Dental Implant SystemLifecore Biomedical, Inc. · 1996
  2. This deviceK031322 Intra-Lock Hydroxyapatite Coated ImplantsIntra-Lock International · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K960288HA & TPS Restore Self Tapping Dental Implant SystemLifecore Biomedical, Inc.1996—
0 (this device)K031322Intra-Lock Hydroxyapatite Coated ImplantsIntra-Lock International2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200120
200210
FIG. 1 — Lineage of K031322, 1996–2003Source: 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? (6)

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
*K021244Ace HA Screw Dental Implant System
Summary page 1
…Cosmetic Act, the device classification is Class III. Predicate Devices: Ace HA Screw Implant System K021244 HA-TI Implant K003045 BMR Dental Implant System…
Ace Surgical Supply Co., Inc.2002—
*K003045HA-TI (Hand Titanium Screw) Implant
Summary page 1
…. Predicate Devices: Ace HA Screw Implant System K021244 HA-TI Implant K003045 BMR Dental Implant System K010343 Replace Ha Coated Implants…
Hati Dental Ag.2001—
*K010343BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated, 3.308, 3.310,3.312…
Summary page 1
…K021244 HA-TI Implant K003045 BMR Dental Implant System K010343 Replace Ha Coated Implants K962845 Sterngold HA Coated Screws…
Buck Medical Research2001—
*K962845Replace HA Coated Implants
Summary page 1
…K003045 BMR Dental Implant System K010343 Replace Ha Coated Implants K962845 Sterngold HA Coated Screws K981516 Restore HA Coated Implants…
Steri-Oss, Inc.1996—
*K981516Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant HA…
Summary page 1
…K010343 Replace Ha Coated Implants K962845 Sterngold HA Coated Screws K981516 Restore HA Coated Implants K960288 Product Description: The Intra-Lock Hydroxyapatit…
Sterngold/Implamed1998—
*K960288HA & TPS Restore Self Tapping Dental Implant System
Summary page 1
…K962845 Sterngold HA Coated Screws K981516 Restore HA Coated Implants K960288 Product Description: The Intra-Lock Hydroxyapatite Coated Implants consists of root form dental implants that are manufactured…
Lifecore Biomedical, Inc.1996—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 6 ancestors has a recall.

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—

What is it indicated for?

The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

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
  • 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

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/K031322 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031322: Intra-Lock Hydroxyapatite Coated Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031322

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