FDA 510(k) Applications for Medical Device Product Code "EBH"
(Material, Impression Tray, Resin)

FDA 510(k) Number Applicant Device Name Decision Date
K802751 3M COMPANY P-10 POSTERIOR FILLING MATERIAL 11/12/1980
K890712 ADVANTAGE DENTAL PRODUCTS, INC. ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS 04/25/1989
K933745 BIO-SYSTEMS RESEARCH PERMAGEN UNIVERSAL BONDING RESIN 01/26/1994
K782153 CHAYET AND SONNENRICH, P.C. IMPRESSION TRAY, MDDS CUSTOM 02/26/1979
K760754 CUTTER LABORATORIES, INC. CUTTER TRAY-ACRYLIC FOR IMP TRAYS 10/15/1976
K820998 DENTRON, INC. DENTRON-DIRECT-TRAY 06/10/1982
K820997 DENTRON, INC. DENTRON-EXACT - TRAY 06/10/1982
K813550 DENTSPLY INTL. HYBRID DENTAL PRODUCT 02/24/1982
K872210 DENTSPLY INTL. IMPRESSION TRAY 06/22/1987
K923979 DENTSPLY INTL. LC TRAY MATERIAL 11/17/1992
K854042 DENTSPLY INTL. RESIN TRAY IMPRESSION MATERIAL 11/07/1985
K844471 DENTSPLY INTL. VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE 02/08/1985
K873739 E&D DENTAL MANUFACTURING CO. ACRYLIC IMPRESSION TRAY MATERIALS 03/07/1988
K912820 E&D DENTAL PRODUCTS, INC. POLYESTER RESIN HAND MOLDED TRAY 08/21/1991
K875257 ESPE GMBH (US) IMPREGUM F ADHESIVE 03/09/1988
K881838 ESPE GMBH (US) MODIFIED PERMAGUM ADHESIVE 07/27/1988
K875228 ESPE GMBH (US) PERMADYNE ADHESIVE 03/09/1988
K923549 HERAEUS KULZER, INC. PALADISC LC 09/29/1992
K930487 HERAEUS KULZER, INC. PALATRAY LC MINT 06/18/1993
K863421 IVOCLAR USA, INC. SR-IVOLEN TRAY MATERIAL 11/03/1986
K810686 J. ADERER, INC. SR-IVOLEN 04/14/1981
K902350 KULZER, INC. PALATRAY LC RESIN IMPRESSION TRAY MATERIAL 07/26/1990
K905058 KULZER, INC. PALAVIT L 06/06/1991
K850014 MEDI-DENT AMERICAN, INC. HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE 01/23/1985
K801780 OXY DENTAL PRODUCTS, INC. OXY CUSTOM TRAY RESIN 08/07/1980
K901782 PRODUCTIVITY TRAINING CORP. CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM 06/29/1990
K853093 PSP DENTAL CO., LTD. PSP TEMP - TRAY 09/06/1985
K831293 SOLAR DENTAL CO., INC. SOLARCRYL CUSTOM TRAY MATERIAL 07/26/1983
K790897 STED, INC. QUAD IV CUSTOM IMPRESSION TRAY 06/15/1979
K852182 THE S. S. WHITE CO. EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER 07/02/1985


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact