510(k) · Cleared

Cleared

Synspar Advanced

K123613510(k) AbbreviatedCleared Feb 20, 201389-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

Cleared on Feb 20, 2013 as substantially equivalent to K050144 (Glidewell Laboratories, 2005) and 1 other predicate after an 89-day review. Its family tree reaches back 3 generations to 1994.

Decided: Feb 20, 2013
Review: 89 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K940252 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK940252 Finesse Porcelain SystemDentsply Intl. · 1994
2 generations backK041335 PTM SystemDentsply International · 2004
1 generation backK071848 Ips Inline Pom SystemIvoclar Vivadent, Inc. · 2007
This deviceK123613 Synspar AdvancedArdent, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K940252	Finesse Porcelain System	Dentsply Intl.	1994	—
−2	K041335	PTM System	Dentsply International	2004	—
−1	K071848	Ips Inline Pom System	Ivoclar Vivadent, Inc.	2007	—
0 (this device)	K123613	Synspar Advanced	Ardent, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K123613, 1994–2013Source: 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
*	K050144	Prismatik Ceramic Summary page 1 …Synspar Advance Pressable Ceramic (Pellets) Classification Name: Porcelain Powder for Clinical Use (872.6660) Predicate Devices: Prismatik NetPress (K050144) IPS InLine PoM System (K071848) Device Description: Synspar Advance Pressable Ceramic (Pelle…	Glidewell Laboratories	2005	—
*	K071848	Ips Inline Pom System Summary page 1 …Name: Porcelain Powder for Clinical Use (872.6660) Predicate Devices: Prismatik NetPress (K050144) IPS InLine PoM System (K071848) Device Description: Synspar Advance Pressable Ceramic (Pellets) is a dental porcelain system composed of a leucite-cera…	Ivoclar Vivadent, Inc.	2007	—

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 19 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
None of the 4 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. 2013, 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?

Synspar Advance Pressable Ceramic (Pellets) is a leucite ceramic system for:

Press-an-Metal Restorations

* Single unit fully anatomical crowns in the anterior and posterior regions

* Fully anatomical splinted crowns and bridges in the anterior and posterior regions

* Compatible with dental alloys in the GTE range 13.6-14.6 x 101IK (25-500*C). Alloys should be copper-free and contain less than 14% silver.

Pressed All-ceramic Restorations

*Adhesively cemented single unit anterior all-ceramic restorations (crowns, inlays, onlays, veneers)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123613: Synspar Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123613

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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