BEACH GINGIVAL RETRACTION INSTR. TYPE B

Retractor, All Types

PACIFIC DENTAL CORP.

The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Beach Gingival Retraction Instr. Type B.

Pre-market Notification Details

Device IDK821784
510k NumberK821784
Device Name:BEACH GINGIVAL RETRACTION INSTR. TYPE B
ClassificationRetractor, All Types
Applicant PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEIG  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-17
Decision Date1982-07-06

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