HANDPIECE, DENTAL

Drill, Dental, Intraoral

AESCULAP INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Handpiece, Dental.

Pre-market Notification Details

Device IDK801888
510k NumberK801888
Device Name:HANDPIECE, DENTAL
ClassificationDrill, Dental, Intraoral
Applicant AESCULAP INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDZA  
CFR Regulation Number872.4130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-07-28
Decision Date1980-08-20

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