510(k) · Cleared
ClearedIcon Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Science Technologies, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 1, 1998 as substantially equivalent to K945398 (Nobelpharma USA, Inc., 1995) after a 213-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 1, 1998
- Review
- 213 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945398 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945398 Branemark System (R) Mkii Self-Tapping FixtureNobelpharma USA, Inc. · 1995
- This deviceK974106 Icon Implant SystemBio Science Technologies, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945398 | Branemark System (R) Mkii Self-Tapping Fixture | Nobelpharma USA, Inc. | 1995 | — |
| 0 (this device) | K974106 | Icon Implant System | Bio Science Technologies, Inc. | 1998 | — |
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? (1)
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 |
|---|---|---|---|
| * | K945398 | Branemark System (R) Mkii Self-Tapping FixtureSummary page 1…nium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc. The Icon Implant System is intended for use in either partially or fully edentulous mandib… | 1995 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K945398.
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 Bio Science Technologies, Inc.’s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc. The Icon Implant System is intended for use in either partially or fully edentulous mandibles and…
Read the full statement (135 words)
The Bio Science Technologies, Inc.’s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc. The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:
. Support of fixed (cemented) restorations utilizing multiple abutments;
. Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
e Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
Terminal or intermediate abutment support for fixed bridgework;
Free standing restorations without involvement of adjacent dentition when the external hex is engaged.
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/K974106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974106: Icon Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974106
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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