PEMACO 3000 INTRAORAL DENTAL WAX

Wax, Dental, Intraoral

PEMACO, INC.

The following data is part of a premarket notification filed by Pemaco, Inc. with the FDA for Pemaco 3000 Intraoral Dental Wax.

Pre-market Notification Details

Device IDK895561
510k NumberK895561
Device Name:PEMACO 3000 INTRAORAL DENTAL WAX
ClassificationWax, Dental, Intraoral
Applicant PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton,  MO  63026
ContactRichard Perkowski
CorrespondentRichard Perkowski
PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton,  MO  63026
Product CodeEGD  
CFR Regulation Number872.6890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-06
Decision Date1989-11-06

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