510(k) · Cleared
Recalled · Class II · 2022E-Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisiontec GmbH · MQC Mouthguard, Prescription
Cleared on Nov 27, 2020 as substantially equivalent to K190107 (Whip Mix Corporation, 2019) after a 210-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 27, 2020
- Review
- 210 days
- Class
- Class U
- Product code
- MQC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924830 (1994). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924830 Luxatemp AutomixDmg Chemisch Pharmazeutische Fabrik GmbH · 1994
- 4 generations backK060293 Temporary Crown and Bridge MaterialDentsply International, Inc. · 2006
- 3 generations backK071548 Wieland Zeno Cao Temporary Pmma Disc, Tooth-ColoredMerz Dental GmbH · 2007
- 2 generations backK150432 Idodentine Disc, Idodentine BlockUnion Dental S.A. · 2015
- 1 generation backK190107 VeriSplintWhip Mix Corporation · 2019
- This deviceK201173 E-GuardEnvisiontec GmbH · 2020
- Descendant · cites it directly · 0 of its ownK222489 Harvest Printable ResinHarvest Dental Products, LLC · 2023
- Descendant · cites it directly · 0 of its ownK210940 LuxaPrint Ortho PlusDmg Digital Enterprises SE · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924830 | Luxatemp Automix | Dmg Chemisch Pharmazeutische Fabrik GmbH | 1994 | — |
| −4 | K060293 | Temporary Crown and Bridge Material | Dentsply International, Inc. | 2006 | — |
| −3 | K071548 | Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored | Merz Dental GmbH | 2007 | — |
| −2 | K150432 | Idodentine Disc, Idodentine Block | Union Dental S.A. | 2015 | — |
| −1 | K190107 | VeriSplint | Whip Mix Corporation | 2019 | — |
| 0 (this device) | K201173 | E-Guard | Envisiontec GmbH | 2020 | — |
| +1 | K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | 2023 | — |
| +1 | K210940 | LuxaPrint Ortho Plus | Dmg Digital Enterprises SE | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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 MQC? 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 MQC device
- #1 K203000 KeyPrint KeySplint Hardscore 15.3 · 5 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 |
|---|---|---|---|
| * | K190107 | VeriSplintSummary page 4…ified 21 CFR 872.3760, Class 2 MQC EBI III. PREDICATE DEVICE Primary Predicate Device: K190107: VeriSplint, Whip Mix Corporation Reference Device K102776: e-DENT Temporary Resin and Extra-Oral Curing System… | 2019 |
| † | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | 2011 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2022 | Class II | Z-0746-2022 | Unknown/Undetermined by firm | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K222489 (Harvest Dental Products, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190107.
How does its category compare?
All MQC devicesMQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MQC
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQC
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQC
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQC
7in 2025
MAUDE reports naming product code MQC, 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 | 4 | 79 | 0 | 9 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 4 | 194 | 0 | 2 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 3 | 234 | 0 | 5 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 2 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 71 |
| 2019 | 5 | 286 | 0 | 62 |
| 2020 | 4 | 204 | 0 | 46 |
| 2021 | 7 | 158 | 0 | 111 |
| 2022 | 5 | 120 | 0 | 137 |
| 2023 | 6 | 230 | 1 | 62 |
| 2024 | 8 | 249 | 0 | 8 |
| 2025 | 4 | 185 | 0 | 7 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201173: E-Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201173
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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