510(k) · Cleared
ClearedTransitional 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 Dec 19, 2002 as substantially equivalent to K972351 (Sendax Mdic Management, Inc., 1997) and 2 other predicates after a 191-day review. Its family tree reaches back 2 generations to 1978.
- Decided
- Dec 19, 2002
- Review
- 191 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K781060 (1978). 13 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K781060 | Monoject Endosseous Dental Implant | Sherwood Medical Industries | 1978 | — |
| −1 | K980620 | Dentatus Mti Modular Transitional Implants and Prosthetic System | Dentatus USA, Ltd. | 1998 | — |
| 0 (this device) | K021915 | Transitional Implants | Intra-Lock International | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K972351 | Sendax Mdi (Mini Dental Implant)Summary page 1…Cosmetic Act, the dcvicr: classification is Class Ill. Predicate Devices: Sendax Mini Dentat Implant K972351 Dentatus Transitional Irnplavts MTI-MP K980620 Irn trc Sendax MDI… | 1997 |
| * | K980620 | Dentatus Mti Modular Transitional Implants and Prosthetic SystemSummary page 1…icate Devices: Sendax Mini Dentat Implant K972351 Dentatus Transitional Irnplavts MTI-MP K980620 Irn trc Sendax MDI K990983 Product Description: The Intra-Lock Internatio… | 1998 |
| * | K990983 | Modification to Imtec Sendax MdiSummary page 1…K972351 Dentatus Transitional Irnplavts MTI-MP K980620 Irn trc Sendax MDI K990983 Product Description: The Intra-Lock International Transitional Implant System consists of root form Transitional Implants and r… | 1999 |
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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- None of the 13 ancestors has a recall.
- 7 other devices also cite its predicate K972351.
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?
This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021915: Transitional Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021915
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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