510(k) · Cleared
ClearedP pro Crown & Bridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deltamed GmbH · EBG Crown And Bridge, Temporary, Resin
Cleared on Jul 31, 2020 as substantially equivalent to K102776 (Deltamed GmbH, 2011) and 2 other predicates after a 205-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Jul 31, 2020
- Review
- 205 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K924830 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 2 generations backK013674 Luxatemp/Luxatemp Solar/InstatempDmg USA, Inc. · 2002
- 1 generation backK101710 Luxatemp Ultra /StarDmg USA, Inc. · 2010
- This deviceK200039 P pro Crown & BridgeDeltamed GmbH · 2020
- Descendant · cites it directly · 0 of its ownK243370 DentaTOOTHAsiga Pty, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243370DentaTOOTHAsiga Pty, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −2 | K013674 | Luxatemp/Luxatemp Solar/Instatemp | Dmg USA, Inc. | 2002 | — |
| −1 | K101710 | Luxatemp Ultra /Star | Dmg USA, Inc. | 2010 | — |
| 0 (this device) | K200039 | P pro Crown & Bridge | Deltamed GmbH | 2020 | — |
| +1 | K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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 |
|---|---|---|---|
| * | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing SystemSummary page 5…in Lab (3) Predicate Device : Luxatemp Ultra / Luxatemp Star Submission: Class. Name: Product Code Regulation No. (1) K102776 Crown and Bridge, Temporary, Resin EBG 872.3770 (2) K070991 Crown and Bridge, Temporary, Resin… | 2011 |
| * | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202…Summary page 5…lass. Name: Product Code Regulation No. (1) K102776 Crown and Bridge, Temporary, Resin EBG 872.3770 (2) K070991 Crown and Bridge, Temporary, Resin EBG 872.3770 (3) K101710 Crown and Bridge, Temporary, Resin… | 2007 |
| * | K101710 | Luxatemp Ultra /StarSummary page 5…Crown and Bridge, Temporary, Resin EBG 872.3770 (2) K070991 Crown and Bridge, Temporary, Resin EBG 872.3770 (3) K101710 Crown and Bridge, Temporary, Resin EBG 872.3770 The table on the following page compares the subje… | 2010 |
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 |
|---|---|---|---|
| K243370 | DentaTOOTH | 2025 | 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 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K243370 (Asiga Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K102776.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Additive production of temporary anterior and posterior restorations, e.g.
- Single tooth crowns.
- Bridges (max. six units, max. two consecutive pontics).
- Veneers, Inlays, Onlays.
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/K200039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200039: P pro Crown & Bridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200039
Report an extraction error
Are you the manufacturer?
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