510(k) · Cleared

Cleared

Cerana

K992161510(k) TraditionalCleared Sep 22, 199989-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

Nordiska Dental AB · EIH Powder, Porcelain

Cleared on Sep 22, 1999 as substantially equivalent to K913372 (Ivoclar North America, Inc., 1991) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1991.

Decided: Sep 22, 1999
Review: 89 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K912256 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK912256 Precise (R) Beta Quartz Glass-Ceramic InsertLee Pharmaceuticals · 1991
This deviceK992161 CeranaNordiska Dental AB · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912256	Precise (R) Beta Quartz Glass-Ceramic Insert	Lee Pharmaceuticals	1991	—
0 (this device)	K992161	Cerana	Nordiska Dental AB	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1997	1	0

FIG. 1 — Lineage of K992161, 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? (3)

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
*	K913372	Ips Empress Summary page 1 …II, EIH Identification of Predicate Devices ¢ Ivoclar North America, Inc. IPS Empress, Ivoclar North America, Inc., 175 Pineview Dr., Amherst, NY 14228; 510(k) number K913372. e Ivoclar North America, Inc. SONICSYS Inlay, Ivoclar North America, Inc., 175 Pineview Dr., Amherst, NY 14228; 510(k) number K…	Ivoclar North America, Inc.	1991	—
*	K972648	Sonicsys Inlay Summary page 1 …Amherst, NY 14228; 510(k) number K913372. e Ivoclar North America, Inc. SONICSYS Inlay, Ivoclar North America, Inc., 175 Pineview Dr., Amherst, NY 14228; 510(k) number K972648. ¢ Lee Pharmaceuticals. Precise ® Beta Quartz Glass-Ceramic Insert, Lee Pharmaceuticals, 1444 Santa Anita Avenue, P.O. Box 3836,…	Ivoclar North America, Inc.	1997	—
*	K912256	Precise (R) Beta Quartz Glass-Ceramic Insert Summary page 1 …¢ Lee Pharmaceuticals. Precise ® Beta Quartz Glass-Ceramic Insert, Lee Pharmaceuticals, 1444 Santa Anita Avenue, P.O. Box 3836, South El Monte, CA 91733; 510 (k) number K912256 Device Description; CERANA is an all-ceramic inlay that has the same translucency as enamel, can be finished and polished just…	Lee Pharmaceuticals	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 3 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?

CERANA is designed to be used in class I primary and secondary caries/replacement of filling; class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.

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/K992161 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992161: Cerana.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992161

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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