510(k) · Cleared
ClearedEndossous Implants
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 Jul 24, 2002 as substantially equivalent to K944683 (Nobelpharma USA, Inc., 1995) and 4 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Jul 24, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K894595 (1990). 13 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 1 generation backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- This deviceK021322 Endossous ImplantsIntra-Lock International · 2002
- Descendant · cites it directly · 5 of its ownK103194 Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · 2 generations on · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK132178 Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014
- Descendant · 2 generations on · 0 of its ownK133613 Intra-Lock Dental ImplantsIntra-Lock International, Inc. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc. · 2011 · cites it directly5descendants
- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · 2 generations on1descendant
- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · 2 generations on0descendants
- K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd · 2014 · 3 generations on0descendants
- K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −1 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| 0 (this device) | K021322 | Endossous Implants | Intra-Lock International | 2002 | — |
| +1 | K103194 | Intra-Lock Dental Implants with Blossom | Intra-Lock International, Inc. | 2011 | — |
| +2 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +2 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
| +3 | K132178 | Mostdi Dental Implant System | Mostdi Innovations Sdn Bhd | 2014 | — |
| +2 | K133613 | Intra-Lock Dental Implants | Intra-Lock International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K944683 | Branemark System 3.3MM FixtureSummary page 1…od, Drug, and Cosmetic Act, the device classification is Class Ill. Predicate Devices: Branemark Dental Implant System K944683 Branemark MklI Dental Implants K945398 Lifecore Self Tapping Implants K950624… | 1995 |
| * | K945398 | Branemark System (R) Mkii Self-Tapping FixtureSummary page 1…ice classification is Class Ill. Predicate Devices: Branemark Dental Implant System K944683 Branemark MklI Dental Implants K945398 Lifecore Self Tapping Implants K950624 Lifecore Stage 1 RBM Implants KO03226… | 1995 |
| * | K950624 | HA- and TPS- Restore Self Tapping Dental Implant SystemSummary page 1…Branemark Dental Implant System K944683 Branemark MklI Dental Implants K945398 Lifecore Self Tapping Implants K950624 Lifecore Stage 1 RBM Implants KO03226 IT1 Strauman One Part Implants K994 104 Pro… | 1995 |
| * | K003226 | The Lifecore Stage-1 Single Stage RBM Dental Implant System | 2001 |
| * | K984104 | Iti Dental Implant System Our reading of the summary gave K994104, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ITI Straumann One Part Implants”. | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103194 | Intra-Lock Dental Implants with Blossom | 2011 | 5 |
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 12 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K103194 (Intra-Lock International, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K944683.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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 prosthesis, from single tooth replacement to full arch reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021322: Endossous Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021322
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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