510(k) · Cleared
ClearedIntra-Lock Dental Implants with Blossom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra-Lock International, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 21, 2011 as substantially equivalent to K021322 (Intra-Lock International, 2002) and 1 other predicate after a 174-day review. Its family tree reaches back 9 generations to 1993. 5 later devices descend from it.
- Decided
- Apr 21, 2011
- Review
- 174 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K925765 (1993). 67 ancestors in all, the oldest K781060 (1978). 5 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK072363 Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc. · 2008
- This deviceK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · cites it directly · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
- Descendant · cites it directly · 0 of its ownK133613 Intra-Lock Dental ImplantsIntra-Lock International, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK111199 Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc. · 2011
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK072363 Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexBiomet 3i, Inc. · 2008
- This deviceK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · cites it directly1descendant
- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · cites it directly0descendants
- K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014 · 2 generations on0descendants
- K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc. · 2014 · cites it directly0descendants
- K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex | Biomet 3i, Inc. | 2008 | — |
| 0 (this device) | K103194 | Intra-Lock Dental Implants with Blossom | Intra-Lock International, Inc. | 2011 | — |
| +1 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +1 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
| +2 | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
| +1 | K133613 | Intra-Lock Dental Implants | Intra-Lock International, Inc. | 2014 | — |
| +1 | K111199 | Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled Abutments | Intra-Lock International, Inc. | 2011 | — |
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 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021322 | Endossous ImplantsSummary page 1…561-447-8283 Classification Name: Endlosseous Dental Implant 21 CFR 872.3640 Trade Name: Intra-Lock Dental Implant System with Blossom Legally Marketed Device: K021322 Intra-Lock Dental Implant System, K063341 Certain dental implants and K072363 Nanotite dental implants Device Description: The I… | 2002 |
| * | K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External HexSummary page 1…2.3640 Trade Name: Intra-Lock Dental Implant System with Blossom Legally Marketed Device: K021322 Intra-Lock Dental Implant System, K063341 Certain dental implants and K072363 Nanotite dental implants Device Description: The Intra-Lock Endlosseous Dental Implant System with Blossom isa screw-type implan… | 2008 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 8 of the 67 ancestors have a recall of any class.
- Of its descendants, K130140 (Intra-Lock International, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Intra-Lock Dental Implant System has 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 prothesis, from single tooth replacement to full arch reconstruction. They are intended for immediate function on single 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 as stated in the FDA summary.
https://510kreport.com/device/K103194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103194: Intra-Lock Dental Implants with Blossom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103194
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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