PANASIL IMPRESSION MATERIAL

Material, Impression

ROYDENT DENTAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Roydent Dental Products, Inc. with the FDA for Panasil Impression Material.

Pre-market Notification Details

Device IDK954281
510k NumberK954281
Device Name:PANASIL IMPRESSION MATERIAL
ClassificationMaterial, Impression
Applicant ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills,  MI  48309
ContactDon Leroy
CorrespondentDon Leroy
ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills,  MI  48309
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-13
Decision Date1996-06-24

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