510(k) · Cleared
ClearedImmediate Stabilizing Implant (Isi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O Co., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 10, 2003 as substantially equivalent to K983120 (Oraltronics Marketing-Und Vertriebs GmbH, 1999) and 3 other predicates after a 48-day review. Its family tree reaches back 2 generations to 1982. 5 later devices descend from it.
- Decided
- Dec 10, 2003
- Review
- 48 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K820013 (1982). 10 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK820013 Titanium Implant DevicesBofors Nobelpharma, Inc. · 1982
- 1 generation backK983120 Bicortical ScrewOraltronics Marketing-Und Vertriebs GmbH · 1999
- This deviceK033392 Immediate Stabilizing Implant (Isi)O Co., Inc. · 2003
- Descendant · cites it directly · 4 of its ownK090174 Tsi; EriOco Biomedical · 2009
- Descendant · cites it directly · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · 2 generations on · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142846 BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
Most influential descendants
Showing 5 of 5 · See all- K090174Tsi; EriOco Biomedical · 2009 · cites it directly4descendants
- K110337Universal Maxillary MolarOco Biomedical · 2012 · cites it directly1descendant
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · 2 generations on0descendants
- K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016 · cites it directly0descendants
- K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820013 | Titanium Implant Devices | Bofors Nobelpharma, Inc. | 1982 | — |
| −1 | K983120 | Bicortical Screw | Oraltronics Marketing-Und Vertriebs GmbH | 1999 | — |
| 0 (this device) | K033392 | Immediate Stabilizing Implant (Isi) | O Co., Inc. | 2003 | — |
| +1 | K090174 | Tsi; Eri | Oco Biomedical | 2009 | — |
| +1 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +2 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
| +1 | K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | 2016 | — |
| +1 | K122198 | 6.00MM X 6.00MM Macro External Implant System | Oco Biomedical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K983120 | Bicortical ScrewSummary page 1…ing Implant Common Name: Endosseous Screw Implant Classification Name: Dental Implant Endosseous / Code 76DZE Substantial Equivalence to: Bicortical Screw K983 120 Cleared 7/29/99 LaminOss K982925 Cleared 5/15/99 Altiva K9925 12… | 1999 |
| * | K982925 | Laminoss Dental ImplantSummary page 1…fication Name: Dental Implant Endosseous / Code 76DZE Substantial Equivalence to: Bicortical Screw K983 120 Cleared 7/29/99 LaminOss K982925 Cleared 5/15/99 Altiva K9925 12 Cleared 11/1/99 Crystal Stableden… | 1999 |
| * | K992512 | Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation…Summary page 1…tial Equivalence to: Bicortical Screw K983 120 Cleared 7/29/99 LaminOss K982925 Cleared 5/15/99 Altiva K9925 12 Cleared 11/1/99 Crystal Stabledent K01 1502 10/22/01 Description of Device: Self-tappin… | 1999 |
| * | K011502 | Crystal and Crystal-Care Implants SystemSummary page 1…LaminOss K982925 Cleared 5/15/99 Altiva K9925 12 Cleared 11/1/99 Crystal Stabledent K01 1502 10/22/01 Description of Device: Self-tapping one-piece CP Titanium threaded dental impl… | 2001 |
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 21 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K090174 (Oco Biomedical, 2009) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K983120.
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 Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted between the mental foramina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033392 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033392: Immediate Stabilizing Implant (Isi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033392
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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