510(k) · Cleared
ClearedAPVolution System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic-Press, LLC · EIH Powder, Porcelain
Cleared on Jun 5, 2017 as substantially equivalent to K141400 (Ceramay GmbH & Co.Kg, 2015) after a 200-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Jun 5, 2017
- Review
- 200 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K024250 (2003). 12 ancestors in all, the oldest K830955 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK024250 Match Press Pressable CeramicDavis Schottlander & Davis, Ltd. · 2003
- 4 generations backK043221 Willi Geller Creation CP PorcelainJensen Industries, Inc. · 2004
- 3 generations backK070114 Creation CP-ZI PorcelainJensen Industries, Inc. · 2007
- 2 generations backK111743 The Insync Ceramic SystemJensen Industries, Inc. · 2011
- 1 generation backK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- This deviceK163228 APVolution SystemAesthetic-Press, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K024250 | Match Press Pressable Ceramic | Davis Schottlander & Davis, Ltd. | 2003 | — |
| −4 | K043221 | Willi Geller Creation CP Porcelain | Jensen Industries, Inc. | 2004 | — |
| −3 | K070114 | Creation CP-ZI Porcelain | Jensen Industries, Inc. | 2007 | — |
| −2 | K111743 | The Insync Ceramic System | Jensen Industries, Inc. | 2011 | — |
| −1 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| 0 (this device) | K163228 | APVolution System | Aesthetic-Press, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2005 | 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 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 |
|---|---|---|---|
| * | K141400 | Dcceram SystemSummary page 4…EIH FDA Regulation: 21 CFR 872.6660 – Porcelain Powder for Clinical Use Device Classification: Class II Premarket Notification: K141400 Indications for Use The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ce… | 2015 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K141400.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163228 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163228: APVolution System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163228
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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