SBP DENTAL UNIT

Unit, Operative Dental

NORTHLAND DENTAL ENGINEERING

The following data is part of a premarket notification filed by Northland Dental Engineering with the FDA for Sbp Dental Unit.

Pre-market Notification Details

Device IDK934436
510k NumberK934436
Device Name:SBP DENTAL UNIT
ClassificationUnit, Operative Dental
Applicant NORTHLAND DENTAL ENGINEERING BOX 150-A Ridgeland,  WI  54763
ContactDewayne Varnes
CorrespondentDewayne Varnes
NORTHLAND DENTAL ENGINEERING BOX 150-A Ridgeland,  WI  54763
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-23
Decision Date1994-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00736239100081 K934436 000

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