510(k) · Cleared

Cleared

Permacem / Permacem Dual

K012316510(k) AbbreviatedCleared Aug 23, 200131-day reviewClass II21 CFR 872.3275

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

Cleared on Aug 23, 2001 as substantially equivalent to K940914 (Dentsply Intl., 1994) and 7 other predicates after a 31-day review. Its family tree reaches back 1 generation to 1992. 5 later devices descend from it.

Decided: Aug 23, 2001
Review: 31 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 9

Its longest line of descent runs back 1 generation to K924151 (1992). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK924151 Bisco D/C ResinomerBisco, Inc. · 1992
This deviceK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
Descendant · cites it directly · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
Descendant · cites it directly · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK162960 TotalC-RamItena Clinical · 2017
Descendant · 2 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007
Descendant · cites it directly · 0 of its ownK030168 Agc CemWieland Dental + Technik GmbH & Co. KG · 2003

Most influential descendants

Showing 5 of 5 · See all

K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · cites it directly1descendant
K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · cites it directly1descendant
K162960TotalC-RamItena Clinical · 2017 · 2 generations on0descendants
K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · 2 generations on0descendants
K030168Agc CemWieland Dental + Technik GmbH & Co. KG · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924151	Bisco D/C Resinomer	Bisco, Inc.	1992	—
0 (this device)	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—
+1	K121804	Provitemp, Dentotemp, Totalcem, Dentocem	Itena Clinical	2013	—
+1	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—
+2	K162960	TotalC-Ram	Itena Clinical	2017	—
+2	K063444	Total Etch Bonding Agent	Dmg USA, Inc.	2007	—
+1	K030168	Agc Cem	Wieland Dental + Technik GmbH & Co. KG	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	4	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2007	1	0
2013	1	0
2017	1	0

FIG. 1 — Lineage of K012316, 1992–2017Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (12)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K940914	New Luting Cement Material (NLC) Summary page 1 …uting material Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class IL. Predicate Devices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 P…	Dentsply Intl.	1994	—
*	K940513	Optibond Summary page 1 …cording to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class IL. Predicate Devices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Var…	Kerr Corporation (Danbury)	1994	—
*	K940030	Bisco Composite Summary page 1 …Drug, and Cosmetic Act, the device classification is Class IL. Predicate Devices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown D…	Bisco, Inc.	1994	—
*	K922249	Flexi-Flow Cement Natural Summary page 1 …he device classification is Class IL. Predicate Devices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji…	Essential Dental Systems, Inc.	1994	—
*	K960464	C & B Metabond (Modification) Summary page 1 …s Class IL. Predicate Devices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji Plus) K946100 GC Resinomer…	Parkell, Inc.	1996	—
Kept off the family tree	K943596	FDA’s K943596 is Vantage, for Adac Gamma Cameras Our OCR of the scanned summary read K943596, FDA’s number for Vantage, for Adac Gamma Cameras (Adac Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Duolink”. Kept off the family tree. Summary page 1 …evices: Advance K 940914 Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji Plus) K946100 GC Resinomer K924151 Bisco Cement-It…	Adac Laboratories	1995	—
*	K931309	Variolink Summary page 1 …Dentsply Int'l. Optibond K940513 Kerr Mfg. Co. C&B Luting Composite K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji Plus) K946100 GC Resinomer K924151 Bisco Cement-It Unknown Jeneric/Pentron…	Ivoclar North America, Inc.	1993	—
*	K946100	Fuji Duet Summary page 1 …K 940030 Bisco Flexi-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji Plus) K946100 GC Resinomer K924151 Bisco Cement-It Unknown Jeneric/Pentron Inc. ABC Dual Adhesive Bridge Cement Unknown Vivadent Product Descr…	GC America, Inc.	1995	—
*	K924151	Bisco D/C Resinomer Summary page 1 …-Flow K922249 EDS C&B Metabond K960464 Parkell Duolink K 943596 Bisco Variolink K931309 Vivadent Dyract Cem Unknown Dentsply Fuji Duet (Fuji Plus) K946100 GC Resinomer K924151 Bisco Cement-It Unknown Jeneric/Pentron Inc. ABC Dual Adhesive Bridge Cement Unknown Vivadent Product Description: PermaCem: P…	Bisco, Inc.	1992	—
*	—	Dyract Cem Named without a submission number			—
*	—	Cement-It Named without a submission number			—
*	—	ABC Dual Adhesive Bridge Cement Named without a submission number			—

Also cleared against K940914: 2 other devices →

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121804	Provitemp, Dentotemp, Totalcem, Dentocem	Itena Clinical	2013	1
K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	1
K030168	Agc Cem	Wieland Dental + Technik GmbH & Co. KG	2003	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?

None of the 8 ancestors has a recall.
Of its descendants, K121804 (Itena Clinical, 2013) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K940914.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

PermaCem is a chemical cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual is a dual cure compomer cement for permanent luting of metal, resin, or ceramic crowns, bridges, inlays and onlays.

PermaCem Dual can also be used for:

Luting of orthodontic anchors and brackets

Luting of abutments for dentures

Core build-up

Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials

Repair material for resin-based provisionals

Bite registration material

Occlusal individualisation of plastic bite rails

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/K012316 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012316: Permacem / Permacem Dual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012316

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026