Description of Event or Problem · 1
GIVEN THAT "OTC" DENTURE RELINER PRODUCTS ARE REGULATED ITEMS, I RECENTLY PURCHASED AN "INSTA DENTURE RELINE KIT" FROM A SELLER ON (B)(4). THE PRODUCT ARRIVED AND UPON INSPECTION I RECEIVED A QUANTITY OF WHAT I SUSPECT ARE POLYCAPROLACTONE (PCL) PLASTIC PELLETS, WHICH ARE COMMONLY USED AS "HOBBY PLASTIC" WHICH SOFTENS AND IS PLIABLE AT 60 DEGREES CELSIUS. THE PROVIDED MATERIAL IS HEATED AND MOLDED TO THE ILL-FITTING DENTURE. I SUSPECT THAT THE SALE OF THIS PRODUCT IS NON-COMPLIANT WITH REGULATIONS REGARDING THE CERTIFICATION FOR SALE AS A OTC MEDICAL DEVICE WAS LISTED IN "GUIDANCE FOR INDUSTRY AND FDA STAFF-OTC DENTURE CUSHIONS, PADS, RELINERS, REPAIR KITS, AND PARTIALLY FABRICATED DENTURE KITS". (DOCUMENT ISSUED ON: (B)(6) 1998), (B)(4), OFFICE OF DEVICE EVAL) DOCUMENT SHELF NUMBER (B)(4). I BELIEVE THAT SALES OF THIS PRODUCT SHOULD BE HALTED UNTIL THE SELLER CAN DEMONSTRATE COMPLIANCE WITH FDA MEDICAL DEVICE REGULATIONS AND REQUIREMENTS, MOST NOTABLY MATERIAL SAFETY AND DATA SHEET AND PRODUCT CERTIFICATION. APPARENTLY THIS ITEM HAS BEEN SOLD FOR OVER A YEAR, "OUT OF A POST OFFICE BOX" IN (B)(4), TO A (B)(4) ACCOUNT LISTED AS "(B)(4)". THE (B)(4) ITEM NUMBER IS (B)(4). THE SELLER IS "(B)(4)". THE ITEM IS LISTED AS "INSTA DENTURE RELINE KIT". I DO NOT BELIEVE THAT COMMERCIAL "HOBBY PLASTICS" SUCH AS PCL SOLD UNDER VARIOUS TRADENAMES (SUCH AS "INSTAMORPH", "FRIENDLY PLASTIC", "SHAPELOCK", "POLYMORPH", "PLASTIMAKE", "PROTOPLAST", "PLAAST" ETC.) RISE TO THE LEVEL OF SUBSTANCES WHICH ARE ACCEPTABLE TO LONG TERM STORAGE IN, AND CONTACT WITH, THE MOUTH. I RESPECTFULLY REQUEST THAT THIS PRODUCT BE EVALUATED FOR ELIGIBILITY AS AN APPROVED MEDICAL DEVICE, AND THE PROVIDER EVALUATED FOR COMPLIANCE, NOT EXCLUDING TAXATION FOR THIS CLASS OF PRODUCT. RESPECTFULLY, (B)(6).