IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE

Handpiece, Air-powered, Dental

GLENWOOD, LLC.

The following data is part of a premarket notification filed by Glenwood, Llc. with the FDA for Impact Air 45 Handpiece For Periodontal Use.

Pre-market Notification Details

Device IDK972376
510k NumberK972376
Device Name:IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE
ClassificationHandpiece, Air-powered, Dental
Applicant GLENWOOD, LLC. 82 NORTH SUMMIT ST. Tenafly,  NJ  07670
ContactJohn I Gruen
CorrespondentJohn I Gruen
GLENWOOD, LLC. 82 NORTH SUMMIT ST. Tenafly,  NJ  07670
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-25
Decision Date1997-09-10
Summary:summary

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