GLASION

Cement, Dental

SCIENTIFIC PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Glasion.

Pre-market Notification Details

• Device ID: K895386
• 510k Number: K895386
• Device Name: GLASION
• Classification: Cement, Dental
• Applicant: SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010
• Contact: Jan A Orlowski
• Correspondent: Jan A Orlowski; SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-08-30
• Decision Date: 1990-04-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816526023856	K895386	000
D801SP510221	K895386	000
D801SP51022B1	K895386	000
D801SP51025B1	K895386	000
D801SP51025N1	K895386	000
D801SP51031	K895386	000
D801SP510311	K895386	000
D801SP510411	K895386	000
D801SP510421	K895386	000
D801SP51021B1	K895386	000
D801SP510211	K895386	000
00858290006444	K895386	000
D801SP50021	K895386	000
D801SP500211	K895386	000
D801SP50021B1	K895386	000
D801SP500221	K895386	000
D801SP50022B1	K895386	000
D801SP5002S1	K895386	000
D801SP51021	K895386	000
D801SP5104S1	K895386	000
00858290006437	K895386	000
00858290006369	K895386	000
00816526020114	K895386	000
00816526020121	K895386	000
00816526020268	K895386	000
00816526020565	K895386	000
00816526020572	K895386	000
00816526021074	K895386	000
00816526021081	K895386	000
00816526021449	K895386	000
00816526020107	K895386	000
00816526020091	K895386	000
00858290006376	K895386	000
00858290006321	K895386	000
00858290006338	K895386	000
00858290006345	K895386	000
00858290006352	K895386	000
00816526020060	K895386	000
00816526020077	K895386	000
00816526020084	K895386	000
00816526021463	K895386	000