510(k) · Cleared
ClearedPerfit CL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vatech Mcis Co., Ltd. · EIH Powder, Porcelain
Cleared on Jun 20, 2023 as substantially equivalent to K173769 (Dmax Co., Ltd., 2018) after a 264-day review. Its family tree reaches back 4 generations to 2013.
- Decided
- Jun 20, 2023
- Review
- 264 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K123680 (2013). No later device cites it as a predicate yet.
- Root · 4 generations backK123680 CoprancolorWhite Peaks Dental Systems GmbH & Co. KG · 2013
- 3 generations backK141723 Upcera Coloring Liquid (I and II )Liaoning Upcera Co., Ltd. · 2014
- 2 generations backK143090 Luminesse Pre-Sintered Zirconia Coloring LiquidTalladium, Inc. · 2015
- 1 generation backK173769 DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid…Dmax Co., Ltd. · 2018
- This deviceK223029 Perfit CLVatech Mcis Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K123680 | Coprancolor | White Peaks Dental Systems GmbH & Co. KG | 2013 | — |
| −3 | K141723 | Upcera Coloring Liquid (I and II ) | Liaoning Upcera Co., Ltd. | 2014 | — |
| −2 | K143090 | Luminesse Pre-Sintered Zirconia Coloring Liquid | Talladium, Inc. | 2015 | — |
| −1 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon… | Dmax Co., Ltd. | 2018 | — |
| 0 (this device) | K223029 | Perfit CL | Vatech Mcis Co., Ltd. | 2023 | — |
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 EIH? 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 EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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 |
|---|---|---|---|
| * | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring LiquidSummary page 4…duct Code EIH 5.3 Predicated or legally marketed devices which are substantially equivalent Primary Predicate device: K173769, “DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid”, manufactured by… | 2018 |
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?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K173769.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, 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 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
Perfit CL can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223029 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223029: Perfit CL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223029
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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