Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Shofu Dental Corporation · Predicate Candidate Screening

38 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

107 daysmedian FDA review time

240 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K252808	GlasIonomer FX-LC	Shofu Dental Corporation	2025-12-09	97
K252165	ZIRCONOMER P	Shofu Dental Corporation	2025-10-28	110
K251470	ResiCem EX	Shofu Dental Corporation	2025-07-11	59
K251578	BEAUTIFIL II	Shofu Dental Corporation	2025-05-27	5
K233161	BeautiLink SA	Shofu Dental Corporation	2023-09-28	1
K222253	GlasIonomer FX ULTRA	Shofu Dental Corporation	2022-09-22	57
K212939	Vintage Prime Press	Shofu Dental Corporation	2022-03-18	184
K213965	BeautiBond Xtreme	Shofu Dental Corporation	2022-03-18	88
K200470	Shofu Block HC Hard	Shofu Dental Corporation	2021-02-05	345
K191794	Vintage Art Universal	Shofu Dental Corporation	2019-10-03	92
K182869	Fit SA	Shofu Dental Corporation	2019-01-09	89
K181496	VINTAGE PRO	Shofu Dental Corporation	2018-12-18	194
K180803	BeautiBond Universal	Shofu Dental Corporation	2018-09-26	182
K180649	BeautiCem Veneer Kit	Shofu Dental Corporation	2018-06-11	90
K172530	BEAUTIFIL Flow Plus X	Shofu Dental Corporation	2017-12-06	107
K172106	SHOFU MZ Primer Plus	Shofu Dental Corporation	2017-08-31	50
K163568	SHOFU RESIN GLAZE	Shofu Dental Corporation	2017-08-16	240
K162261	CERAMAGE UP	Shofu Dental Corporation	2017-01-11	153
K161891	HC Primer	Shofu Dental Corporation	2016-11-21	133
K160596	BEAUTIFIL II LS	Shofu Dental Corporation	2016-07-27	147
K160086	SHOFU Enamel Conditioner	Shofu Dental Corporation	2016-07-21	188
K151700	BEAUTIFIL II Gingiva	Shofu Dental Corporation	2016-03-02	252
K152392	VINTAGE LD	Shofu Dental Corporation	2016-01-08	137
K152451	VINTAGE Art LF	Shofu Dental Corporation	2015-12-11	105
K151699	BEAUTIFIL II Enamel	Shofu Dental Corporation	2015-12-10	169
K132748	BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK	Shofu Dental Corporation	2013-12-04	92
K132141	BEAUTIFIL BULK FLOWABLE	Shofu Dental Corporation	2013-10-03	84
K130841	SHOFU BLOCK HC	Shofu Dental Corporation	2013-09-11	169
K131504	UNIVERSAL OPAQUE	Shofu Dental Corporation	2013-07-16	53
K122614	VINTAGE MP PRESS OVER	Shofu Dental Corporation	2013-05-16	262
K122908	PRG BARRIER COAT	Shofu Dental Corporation	2013-04-26	217
K123119	CERARESIN BOND	Shofu Dental Corporation	2012-11-28	56
K121749	VERACIA	Shofu Dental Corporation	2012-09-07	85
K120159	BEAUTICEM SA	Shofu Dental Corporation	2012-06-18	151
K112307	RESIGLASS PASTE	Shofu Dental Corporation	2012-03-28	230
K113426	VERACIA SA	Shofu Dental Corporation	2012-02-08	82
K111782	BEAUTISEALANT	Shofu Dental Corporation	2011-09-16	84
K111685	IP TEMP CEMENT	Shofu Dental Corporation	2011-09-02	78

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda