510(k) · Cleared
ClearedFrialit-2 Estheticbase Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friadent GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Dec 20, 2001 after a 64-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 14 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
14 later devices descend from it, 1 citing it directly.
- This deviceK013438 Frialit-2 Estheticbase AbutmentFriadent GmbH · 2001
- Descendant · cites it directly · 13 of its ownK122424 Isus Implant SuprastructuresDentsply International, Inc. · 2013
- Descendant · 2 generations on · 5 of its ownK160207 ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016
- Descendant · 2 generations on · 4 of its ownK212676 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022
- Descendant · 3 generations on · 4 of its ownK163350 Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017
- Descendant · 3 generations on · 3 of its ownK221019 Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122424Isus Implant SuprastructuresDentsply International, Inc. · 2013 · cites it directly13descendants
- K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc. · 2016 · 2 generations on5descendants
- K212676Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Osteon Medical) · 2022 · 2 generations on4descendants
- K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona · 2017 · 3 generations on4descendants
- K221019Osteon Precision Milled SuprastructureImplant Solutions Pty Ltd (Aka Osteon Medical) · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013438 | Frialit-2 Estheticbase Abutment | Friadent GmbH | 2001 | — |
| +1 | K122424 | Isus Implant Suprastructures | Dentsply International, Inc. | 2013 | — |
| +2 | K160207 | ATLANTIS ISUS Implant Suprastructures | Dentsply International, Inc. | 2016 | — |
| +2 | K212676 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Osteon Medical) | 2022 | — |
| +3 | K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | 2017 | — |
| +3 | K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K971706 | FDA’s K971706 is Tiadapt Abutment System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122424 | Isus Implant Suprastructures | 2013 | 13 |
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?
- Of its descendants, K122424 (Dentsply International, Inc., 2013) has gone furthest, with 13 descendants 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.
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 FRLALIT-26D EstheticBase Abutment is intended fbf use to fabricate screw-retained or cemeatabIe crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013438 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013438: Frialit-2 Estheticbase Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013438
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026