BEACH AMALGAM CARVER

Carver, Dental Amalgam, Operative

PACIFIC DENTAL CORP.

The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Beach Amalgam Carver.

Pre-market Notification Details

Device IDK821785
510k NumberK821785
Device Name:BEACH AMALGAM CARVER
ClassificationCarver, Dental Amalgam, Operative
Applicant PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEKH  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-17
Decision Date1982-07-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.