510(k) · Cleared

Cleared

Pavati Zirconia

K151875510(k) TraditionalCleared Oct 29, 2015112-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

Ccri, Inc. · EIH Powder, Porcelain

Cleared on Oct 29, 2015 as substantially equivalent to K062509 (Sirona Dental Systems GmbH, 2006) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 2006.

Decided: Oct 29, 2015
Review: 112 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K060104 (2006). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
1 generation backK123545 Incoris TziSirona Dental Systems GmbH · 2013
This deviceK151875 Pavati ZirconiaCcri, Inc. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K060104	Prismatik Clinical Zirconia	Glidewell Laboratories	2006	—
−1	K123545	Incoris Tzi	Sirona Dental Systems GmbH	2013	—
0 (this device)	K151875	Pavati Zirconia	Ccri, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K151875, 2006–2015Source: 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
*	K062509	Incoris ZI Summary page 4 …r clinical use Submission Number: K151875 product code EIH 3. Predicate Devices Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ), (K062509) and Sirona inCoris TZI (K123545) CCRI, Inc. 510(k) Pavati™ Zirconia Page…	Sirona Dental Systems GmbH	2006	—
*	K123545	Incoris Tzi Summary page 4 …K151875 product code EIH 3. Predicate Devices Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ), (K062509) and Sirona inCoris TZI (K123545) CCRI, Inc. 510(k) Pavati™ Zirconia Page 1 of 4. Indications…	Sirona Dental Systems GmbH	2013	—

Also cleared against K062509: 2 other devices →

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 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K062509.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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?

Pavati™ Zirconia blanks are indicated for use in prosthetic dentistry to create poreelain (ceramic) prostheses (crowns and bridges) in the anterior/ posterior applications. Pavati™ Zirconia blanks are intended to be milled and fully sintered by Dental Professional or Dental Laboratory before use. Pavati™ Zirconia blanks are for "Rx only” and not for use by the general public or sold as “Over-the-Counter”

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/K151875 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151875: Pavati Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151875

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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