PLASTODENT DENTAL IMPRESSION ADHESIVE MANUFACTURED BY PLASTODENT

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Request for Information Form	Contact Information
Company Name	PLASTODENT
Address	2881 MIDDLETOWN RD.
City, State, Zip	BRONX, NY 10461
Country	US
FDA Owner/Operator Phone	718-792-3554
FDA Medical Specialty Code	SU - General Plastic Surgery
FDA Product Code	GBJ
FDA Classification Name	PROSTHESIS, ADHESIVE, EXTERNAL
FDA Device Classification Code	General Controls
FDA Regulation Number	878.3750
FDA Common Generic Name	DENTAL IMPRESSION ADHESIVE
FDA Proprietary Device Name	PLASTODENT DENTAL IMPRESSION ADHESIVE
FDA Owner / Operator Number	9924032
FDA Owner / Operator Name	PLASTODENT
FDA Establishment Registration Number	2418377
FDA Registered Establishment Name	PLASTODENT
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AMOENA MEDIZIN-ORTHOPADIE-TECHNIK GMBH KAPELLENWEG 36 RAUBLING, BAVARIA, D-83064 GM 49-80-358710 / 49-80-35871152	AMOENA CONTACT BREAST FORMS, MULTIPLE	AMOENA CONTACT BREAST FORMS, VARIOUS TYPES & SIZES
2	ATOS MEDICAL AB KRAFTGATAN 8 HORBY, SE-24222 SW 46-415-198 00 / 46-415-198 00	PROVOX SILICONE GLUE	EXTERNAL ADHESIVE FOR PROSTHESIS
3	DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906	SILICONE ADHESIVE	SILICONE ADHESIVE
4	EYEMEE BEAUTY WORLD RM.602,OJU B/D YOKSAM-DONG, GANGNAM-GU SEOUL, 135-080 KS 82-2-508-0797 / 82-2-34719008	MAXI GLUE	ADHESIVE
5	FACTOR, II, INC. 5642 WHITE MOUNTAIN AVE. LAKESIDE, AZ 85929 US 928-537-8387 / 928-537-8387 224	ADHESIVE	ADHESIVE
6	HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. SKOKIE, IL 60076 US 847-679-3400 / 847-679-3400	TAC	TAC
7	NEARLY ME TECHNOLOGIES, INC. 3630 SOUTH I-35, SUITE A WACO, TX 76706 US 254-662-1752 / 254-662-1752 229	NEARLY ME SILICONE SECURITY STRIPS	SILICONE PROSTHESIS ADHESIVE
8	SMITHS MEDICAL ASD, INC. 5700 WEST 23RD AVE. GARY, IN 46406 US 114-420-8-458-3232 / 614-791-5568	LIQUID SILICONE ADHESIVE	LIQUID SILICONE ADHESIVE
9	UROCARE PRODUCTS, INC. 2735 MELBOURNE AVE. POMONA, CA 91767 US 909-621-6013 / 909-621-6013 15	URO-BOND SILICONE ADHESIVE	SILICONE ADHESIVE, EXTERNAL USE ONLY