510(k) · Cleared
ClearedPINK CAD/CAM disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polident D.O.O., Dental Products Industry · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Sep 28, 2016 as substantially equivalent to K140758 (Merz Dental GmbH, 2014) after a 292-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Sep 28, 2016
- Review
- 292 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901789 (1990). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 4 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 3 generations backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 2 generations backK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- 1 generation backK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- This deviceK153546 PINK CAD/CAM discPolident D.O.O., Dental Products Industry · 2016
- Descendant · cites it directly · 0 of its ownK172683 Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172683Yamahachi Pink CAD/CAM DiskYAMAHACHI DENTAL MFG., Co. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −4 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −3 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| −2 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| −1 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| 0 (this device) | K153546 | PINK CAD/CAM disc | Polident D.O.O., Dental Products Industry | 2016 | — |
| +1 | K172683 | Yamahachi Pink CAD/CAM Disk | YAMAHACHI DENTAL MFG., Co. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · 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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172683 | Yamahachi Pink CAD/CAM Disk | 2018 | 0 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K172683 (YAMAHACHI DENTAL MFG., Co., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140758.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
- Fabrication of dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153546: PINK CAD/CAM disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153546
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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