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

Metalor Dental USA Corp. · Predicate Candidate Screening

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

52 daysmedian FDA review time

93 days90th percentile

67clearances measured

K-number	Device	Applicant	Decided	Review days
K003387	AUROFILM NP	Metalor Dental USA Corp.	2001-01-09	70
K993475	AUROFLUID M, ALLOY NO. 5315	Metalor Dental USA Corp.	1999-12-09	56
K993505	V-DELTA SPECIAL, ALLOY NO. 5154	Metalor Dental USA Corp.	1999-12-08	54
K993506	PAGALINOR 4 , ALLOY NO. 5440	Metalor Dental USA Corp.	1999-12-08	54
K993507	V-SUPRAGOLD, ALLOY NO. 5024	Metalor Dental USA Corp.	1999-12-06	52
K993508	V-SUPRA PLUS, ALLOY NO. 5025	Metalor Dental USA Corp.	1999-12-06	52
K993474	DELTAPAL, ALLOY NO. 5161	Metalor Dental USA Corp.	1999-12-02	49
K982606	AUROFLUID CPF	Metalor Dental USA Corp.	1998-10-15	80
K973372	AUROFILM 2000	Metalor Dental USA Corp.	1997-11-26	79
K972683	V-DELTA 450	Metalor Dental USA Corp.	1997-08-18	32
K970044	AUROFLUID 22	Metalor Dental USA Corp.	1997-03-05	58
K970045	SOLARO 33	Metalor Dental USA Corp.	1997-03-05	58
K954702	IMPLANTALOY	Metalor Dental USA Corp.	1995-10-30	18
K951271	VS11 SF	Metalor Dental USA Corp.	1995-06-22	93
K952499	VS1 PLUS	Metalor Dental USA Corp.	1995-06-16	17
K952122	V-GNATHOS PLUS	Metalor Dental USA Corp.	1995-06-06	32
K933563	VS 1A	Metalor Dental USA Corp.	1993-10-20	90
K924155	SURA SNAP	Metalor Dental USA Corp.	1993-05-12	267
K925973	VS1 GPF, VACU PF	Metalor Dental USA Corp.	1993-03-31	126
K925974	CASTING GOLD,CERAMIC,GOLD WIRE,ALLOY PRECISION ATT	Metalor Dental USA Corp.	1993-03-31	126
K924292	CERAPALL 6 -- MODIFIED	Metalor Dental USA Corp.	1993-03-01	245
K921794	CERADELTA 2	Metalor Dental USA Corp.	1992-07-02	83
K915111	PONTOR MPF,V-GNATHOS PF,24K CASTING GOLD	Metalor Dental USA Corp.	1992-01-31	79
K914627	PLATINUM FOIL PLATINUM MILING WAFER	Metalor Dental USA Corp.	1991-11-13	28
K912435	DENTAL CONNECTOR PRECISION ATTACHMENT	Metalor Dental USA Corp.	1991-08-28	86
K912720	ENDO-CORE	Metalor Dental USA Corp.	1991-08-20	63
K912721	AUROFILM MP	Metalor Dental USA Corp.	1991-08-20	63
K911669	CERAPALL 6	Metalor Dental USA Corp.	1991-08-16	127
K911674	CERAPLUS	Metalor Dental USA Corp.	1991-08-16	127
K912302	VACU 2	Metalor Dental USA Corp.	1991-08-09	80
K912305	STANDARD S3	Metalor Dental USA Corp.	1991-08-09	80
K912307	STANDARD S31	Metalor Dental USA Corp.	1991-08-09	80
K912308	STANDARD S32	Metalor Dental USA Corp.	1991-08-09	80
K912313	SOLCHROM-PAL	Metalor Dental USA Corp.	1991-08-09	80
K911671	CERADELTA	Metalor Dental USA Corp.	1991-07-10	90
K911545	V-DELTA	Metalor Dental USA Corp.	1991-07-02	92
K912314	800 SOLDER	Metalor Dental USA Corp.	1991-07-02	42
K912315	V-DELTA S1	Metalor Dental USA Corp.	1991-07-02	42
K912567	CONICAST, INTRACAST, OMECAST	Metalor Dental USA Corp.	1991-07-02	21
K911668	CERAPALL 2	Metalor Dental USA Corp.	1991-06-27	77
K911675	PAGALIN 2	Metalor Dental USA Corp.	1991-06-27	77
K911677	SELECTOR 3	Metalor Dental USA Corp.	1991-06-27	77
K912297	VS1G	Metalor Dental USA Corp.	1991-06-26	36
K912298	VS1	Metalor Dental USA Corp.	1991-06-26	36
K912299	VS1B	Metalor Dental USA Corp.	1991-06-26	36
K912300	VS11	Metalor Dental USA Corp.	1991-06-26	36
K912303	STANDARD S1	Metalor Dental USA Corp.	1991-06-26	36
K912304	STANDARD S2	Metalor Dental USA Corp.	1991-06-26	36
K912306	STANDARD S4	Metalor Dental USA Corp.	1991-06-26	36
K912309	STANDARD S33	Metalor Dental USA Corp.	1991-06-26	36

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