FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

PY-CO-PROX TM DENTAL BRUSH

K Number: K800831 · Decision May 8, 1980
Classifications
1
FEI Numbers
573
Registration Numbers
574
Same Product Code
48
Applicant Total
10
Review Days
24

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Basic Information

Device Name
PY-CO-PROX TM DENTAL BRUSH
K Number
K800831
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6855
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Block Drug Company, Inc.
Date Received
April 14, 1980
Decision Date
May 8, 1980
Product Code
EFW
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EFW Toothbrush, Manual

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K884533 SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
K881974 PROFICIENT(TM) PROPHYLAXIS ANGLE
K872225 SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
K862876 NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
K791064 DUO TWO LAYER DENTURE CLEANSER
K780849 DENTROL LIQUID DENTURE ADHESIVE