510(k) · Cleared

Cleared

Periacryl

K974097510(k) TraditionalCleared Apr 9, 1998161-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

Blacklock Medical Products, Inc. · EMA Cement, Dental

Cleared on Apr 9, 1998 after a 161-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Apr 9, 1998
Review: 161 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK974097 PeriacrylBlacklock Medical Products, Inc. · 1998
Descendant · cites it directly · 1 of its ownK071484 Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK142130 Oral BondSteiner Laboratories · 2016

Most influential descendants

Showing 2 of 2 · See all

K071484Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007 · cites it directly1descendant
K142130Oral BondSteiner Laboratories · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974097	Periacryl	Blacklock Medical Products, Inc.	1998	—
+1	K071484	Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040	Glustitch, Inc.	2007	—
+2	K142130	Oral Bond	Steiner Laboratories	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2016	1	0

FIG. 1 — Lineage of K974097, 1998–2016Source: 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

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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
*	—	Indermil™ Dental Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K071484	Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040	Glustitch, Inc.	2007	1

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?

Of its descendants, K071484 (Glustitch, Inc., 2007) has gone furthest, with 1 descendant of its own.

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?

Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps, and pins.

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/K974097 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974097: Periacryl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974097

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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