PLASTICEPH

Cephalometer

MORNINGSTAR DENTAL CO.

The following data is part of a premarket notification filed by Morningstar Dental Co. with the FDA for Plasticeph.

Pre-market Notification Details

Device IDK810538
510k NumberK810538
Device Name:PLASTICEPH
ClassificationCephalometer
Applicant MORNINGSTAR DENTAL CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEAG  
CFR Regulation Number872.1830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-02-26
Decision Date1981-04-29

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