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Dental Waterline Treatment Cartridge

QYJ · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6640

Classification

FDA Product Code
QYJ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.6640
Review panel
DE
Medical specialty
Dental
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Intended to reduce microbial bioburden in dental unit water lines

Market data

Cleared 510(k) submissions
1
Registered establishments
3

Source

Authoritative
FDA Device Classification database
Machine
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