DENTAL NEEDLE PROTECTIVE SYSTEM

Needle, Dental

HEALTH TECHNOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Health Technology Systems, Inc. with the FDA for Dental Needle Protective System.

Pre-market Notification Details

Device IDK910475
510k NumberK910475
Device Name:DENTAL NEEDLE PROTECTIVE SYSTEM
ClassificationNeedle, Dental
Applicant HEALTH TECHNOLOGY SYSTEMS, INC. 114 WOODLAND AVE. Lexington,  KY  40502
ContactHenry Evans
CorrespondentHenry Evans
HEALTH TECHNOLOGY SYSTEMS, INC. 114 WOODLAND AVE. Lexington,  KY  40502
Product CodeDZM  
CFR Regulation Number872.4730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-06
Decision Date1991-09-13

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