510(k) · Cleared
ClearedOpc Lowwear Porcelain
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 Aug 18, 1998 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 18, 1998
- Review
- 41 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982377 Opc Lowwear PorcelainJeneric/Pentron, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK993249 Opc Low Wear Opaque PorcelainJeneric/Pentron, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K993249Opc Low Wear Opaque PorcelainJeneric/Pentron, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982377 | Opc Lowwear Porcelain | Jeneric/Pentron, Inc. | 1998 | — |
| +1 | K993249 | Opc Low Wear Opaque Porcelain | Jeneric/Pentron, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K993249 | Opc Low Wear Opaque Porcelain | 1999 | 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?
- Of its descendants, K993249 (Jeneric/Pentron, Inc., 1999) has gone furthest, with 0 descendants of its own.
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?
OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 pm, with a crystal size range between 1-4 ym. The…
Read the full statement (107 words)
OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 pm, with a crystal size range between 1-4 ym. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 pm) resuits in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982377: Opc Lowwear Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982377
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