510(k) · Cleared
ClearedOpc 3G All-Ceramic System, Core and Overlay Porcelains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · EIH Powder, Porcelain
Cleared on Feb 10, 2000 as substantially equivalent to K971869 (Dentsply Intl., 1997) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1983. 5 later devices descend from it.
- Decided
- Feb 10, 2000
- Review
- 42 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830955 (1983). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 1 generation backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- This deviceK994435 Opc 3G All-Ceramic System, Core and Overlay PorcelainsJeneric/Pentron, Inc. · 2000
- Descendant · cites it directly · 3 of its ownK141400 Dcceram SystemCeramay GmbH & Co.Kg · 2015
- Descendant · 2 generations on · 1 of its ownK192251 Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020
- Descendant · 3 generations on · 0 of its ownK251084 zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025
- Descendant · 2 generations on · 0 of its ownK163228 APVolution SystemAesthetic-Press, LLC · 2017
- Descendant · cites it directly · 0 of its ownK063842 Cyrtina SystemOratio B.V. · 2007
Most influential descendants
Showing 5 of 5 · See all- K141400Dcceram SystemCeramay GmbH & Co.Kg · 2015 · cites it directly3descendants
- K192251Livento Press, Soprano 10, SopranoCendres+Metaux SA · 2020 · 2 generations on1descendant
- K251084zirkon; structure; LFU shades, stains and glazesEstetic Ceram AG · 2025 · 3 generations on0descendants
- K163228APVolution SystemAesthetic-Press, LLC · 2017 · 2 generations on0descendants
- K063842Cyrtina SystemOratio B.V. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −1 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| 0 (this device) | K994435 | Opc 3G All-Ceramic System, Core and Overlay Porcelains | Jeneric/Pentron, Inc. | 2000 | — |
| +1 | K141400 | Dcceram System | Ceramay GmbH & Co.Kg | 2015 | — |
| +2 | K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | 2020 | — |
| +3 | K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025 | — |
| +2 | K163228 | APVolution System | Aesthetic-Press, LLC | 2017 | — |
| +1 | K063842 | Cyrtina System | Oratio B.V. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 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? (4)
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 |
|---|---|---|---|
| * | K971869 | Finesse All-Ceramic SystemSummary page 1…Fax: 203-265-7662 Contact Person: Annmarie Tenero Date Summary Prepared: May 26, 2000 The compositions for 3G All-Ceramic Corc is similar to Finesse All-Ceramic Core, K971869, Dentsply International and Empress2 Core, K982616, Ivoclar North America, in both composition and function. Likewise, the 3G All… | 1997 |
| * | K982616 | Ips Empress 2Summary page 1…Date Summary Prepared: May 26, 2000 The compositions for 3G All-Ceramic Corc is similar to Finesse All-Ceramic Core, K971869, Dentsply International and Empress2 Core, K982616, Ivoclar North America, in both composition and function. Likewise, the 3G All Ceramic overlay used in conjunction with the 3G Co… | 1998 |
| * | — | Finesse Porcelain Named without a submission number | |
| * | — | Empress2 Porcelain Named without a submission number |
What descends from it? (5)
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)
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 17 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141400 (Ceramay GmbH & Co.Kg, 2015) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K971869.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glass-ceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and characterizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used. The dental restoration…
Read the full statement (244 words)
The OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glass-ceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and characterizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used.
The dental restoration is prepared by a lost wax technique. The dental restorations are designed in a wax pattern and invested into refractory. The refractory is burned out to remove the wax and leave a cavity of the dental design. Pellets of 3G All-Ceramic are placed into the investment cavity and transferred to a hot pressing furnace where the investment/pellets are brought to a higher temperature. The temperature is maintained long enough for the glass-ceramic to become molten and then pressed into the cavity creating an exact duplicate of the original wax pattern.
In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM equipment.
The OPC 3G All-Ceramic System, Core and Overlay Porcelains are intended for either hot pressing or CAD/CAM machining all-ceramic dental restorations. The OPC 3G All-Ceramic System, Core and Overlay Porcelains should be used with 3G All-Ceramic materials only and not intermixed with other manufacturers products/porcelains. The system is used for fabrication of dental restorations including inlays, onlays, veneers, single units, and anterior
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/K994435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994435: Opc 3G All-Ceramic System, Core and Overlay Porcelains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994435
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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