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

PERIO PIK

K Number: K905188 · Decision Feb 15, 1991
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
9
Review Days
88

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Basic Information

Device Name
PERIO PIK
K Number
K905188
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.6510
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Teledyne Water Pik
Date Received
November 19, 1990
Decision Date
February 15, 1991
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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K970594 KALGINATE IMPRESSION MATERIAL
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K944162 DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM
K940288 WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT
K931380 WATER PIK PLUS PLAQUE CONTROL SYSTEM
K900547 WATER PIK(R) W/ADD'L CLAIMS
K895259 PIK POCKET(R), MODEL PP-3
K894015 WATER PIK(R)