510(k) · Cleared

Cleared

Opc Low Wear Opaque Porcelain

K993249510(k) TraditionalCleared Nov 29, 199962-day reviewClass II21 CFR 872.6660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jeneric/Pentron, Inc. · EIH Powder, Porcelain

Cleared on Nov 29, 1999 as substantially equivalent to K982377 (Jeneric/Pentron, Inc., 1998) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1991.

Decided: Nov 29, 1999
Review: 62 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K910303 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK910303 Sysnpar PorcelainJeneric/Pentron, Inc. · 1991
This deviceK993249 Opc Low Wear Opaque PorcelainJeneric/Pentron, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910303	Sysnpar Porcelain	Jeneric/Pentron, Inc.	1991	—
0 (this device)	K993249	Opc Low Wear Opaque Porcelain	Jeneric/Pentron, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K993249, 1991–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K982377	Opc Lowwear Porcelain Summary page 1 …n porcelain-fused to metal restorations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment. We believe that OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, which have previously been approved by the FDA, are substantially equivalent. These devices are…	Jeneric/Pentron, Inc.	1998	—
*	K910303	Sysnpar Porcelain Summary page 1 …rations. OPC Low Wear Opaque Porcelain is to be used on patients in a dentist office environment. We believe that OPC Low Wear Porcelain, K982377, and Synspar Porcelain, K910303, which have previously been approved by the FDA, are substantially equivalent. These devices are powder porcelains used for fabri…	Jeneric/Pentron, Inc.	1991	—

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?

None of the 2 ancestors has a recall.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIH

13in 2025

2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007high 187 (2016) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EIH

1in 2025

2007high 21 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EIH

1in 2025

2007high 22 (2021) · low 0 (2007)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 Low Wear Opaque Porcelain is a porcelain powder, which will be bonded to metal copings to form dental restorations. Subsequent layers of translucent porcelains will be fired on top to complete the restoration.

Particularly, to be used with OPC Low Wear Porcelain, K982377 to cover the metal restoration.

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/K993249 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993249: Opc Low Wear Opaque Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993249

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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