510(k) · Cleared

Cleared

Pavati Z40.2 Zirconia

K160867510(k) TraditionalCleared Sep 12, 2016166-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 Sep 12, 2016 as substantially equivalent to K150872 (Prismatik Dentalcraft, Inc., 2015) after a 166-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it.

Decided: Sep 12, 2016
Review: 166 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K150872 (2015). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK150872 BruxZir Anterior Milling BlanksPrismatik Dentalcraft, Inc. · 2015
This deviceK160867 Pavati Z40.2 ZirconiaCcri, Inc. · 2016
Descendant · cites it directly · 0 of its ownK201608 GenesisZr UHT700 ZirconiaUnited Dental Resources Corporation · 2021

Most influential descendants

Showing 1 of 1 · See all

K201608GenesisZr UHT700 ZirconiaUnited Dental Resources Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K150872	BruxZir Anterior Milling Blanks	Prismatik Dentalcraft, Inc.	2015	—
0 (this device)	K160867	Pavati Z40.2 Zirconia	Ccri, Inc.	2016	—
+1	K201608	GenesisZr UHT700 Zirconia	United Dental Resources Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K160867, 2015–2021Source: 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? (1)

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
*	K150872	BruxZir Anterior Milling Blanks Summary page 5 …0 Product Code: EIH Device Classification: Class II 3. Predicate Devices  Prismatik Dentalcraft BruxZir Anterior Milling Blanks-K150872 (Primary Predicate)  Prismatik Dentalcraft BruxZir Anterior-K143330 (Reference Predicate)…	Prismatik Dentalcraft, Inc.	2015	—
†	K143330	BruxZir Anterior	Prismatik Dentalcraft, Inc.	2014	—

Also cleared against K150872: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K201608	GenesisZr UHT700 Zirconia	United Dental Resources Corporation	2021	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?

Its one ancestor has no recall.
Of its descendants, K201608 (United Dental Resources Corporation, 2021) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K150872.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® Z40.2 Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (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.

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/K160867 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160867: Pavati Z40.2 Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160867

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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