510(k) · Cleared
ClearedIntra-Lock OP Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra-Lock International · DZE Implant, Endosseous, Root-Form
Cleared on Aug 1, 2013 as substantially equivalent to K052997 (Zimmer Dental, Inc., 2006) and 3 other predicates after a 191-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Aug 1, 2013
- Review
- 191 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K960026 (1996). 87 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK050970 Milo Dental Implant SystemIntra-Lock International · 2005
- This deviceK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · cites it directly · 0 of its ownK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK050970 Milo Dental Implant SystemIntra-Lock International · 2005
- This deviceK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
Most influential descendants
Showing 1 of 1 · See all- K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −1 | K050970 | Milo Dental Implant System | Intra-Lock International | 2005 | — |
| 0 (this device) | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +1 | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 1…t Classification Name: Implant, Endosseous, Root-Form Classification: Class 11 Regulation Number: 872.3640 Product Code: DZE Predicate Devices: K052997 & K062281 Zimmer® One-Piece Implant K050970, MILO® Implant System,… | 2006 |
| * | K062281 | Zimmer One-Piece Implant, 4.7MM, Straight, Models ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16Summary page 1…cation Name: Implant, Endosseous, Root-Form Classification: Class 11 Regulation Number: 872.3640 Product Code: DZE Predicate Devices: K052997 & K062281 Zimmer® One-Piece Implant K050970, MILO® Implant System, Impla… | 2006 |
| * | K050970 | Milo Dental Implant SystemSummary page 1…ion: Class 11 Regulation Number: 872.3640 Product Code: DZE Predicate Devices: K052997 & K062281 Zimmer® One-Piece Implant K050970, MILO® Implant System, Implant System with Blossomi K103 194,… | 2005 |
| * | K103194 | Intra-Lock Dental Implants with BlossomSummary page 1…® One-Piece Implant K050970, MILO® Implant System, Implant System with Blossomi K103 194, Intra-Lock®& Description The Intra-Lock® OP Dental Implants are threaded dental implants diame… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132178 | Mostdi Dental Implant System | 2014 | 0 |
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 17 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 11 of the 87 ancestors have a recall of any class.
- Of its descendants, K132178 (Mostdi Innovations Sdn Bhd, 2014) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K052997.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The 3.0mm Intra-Lock® OP Dental implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to…
Read the full statement (141 words)
The 3.0mm Intra-Lock® OP Dental implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130140 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130140: Intra-Lock OP Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130140
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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