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

WATER PIK PLUS PLAQUE CONTROL SYSTEM

K Number: K931380 · Decision Sep 20, 1993
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
9
Review Days
186

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Basic Information

Device Name
WATER PIK PLUS PLAQUE CONTROL SYSTEM
K Number
K931380
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6510
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Teledyne Water Pik
Date Received
March 18, 1993
Decision Date
September 20, 1993
Product Code
EFS
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
EFS Unit, Oral Irrigation

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Other Clearances by Teledyne Water Pik

K Number Device Name
K970594 KALGINATE IMPRESSION MATERIAL
K952422 ELASTIC IMPRESSION CREAM
K944162 DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
K940288 WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
K905188 PERIO PIK
K900547 WATER PIK(R) W/ADD'L CLAIMS
K895259 PIK POCKET(R), MODEL PP-3
K894015 WATER PIK(R)