510(k) clearances

Chemo Mouthpiece

Chemo Mouthpiece, LLC · Dental

K232917Substantially EquivalentTraditionalQUA
Open FDA's page for this record
Third party flag
N
City
Closter
Advisory committee description
Dental
Address 1
10 Railroad Ave.
Statement or summary
Summary
Product code
QUA
Zip code
07624
Applicant
Chemo Mouthpiece, LLC
Decision date
2024-01-23
Decision code
SESE
Country code
US
Device name
Chemo Mouthpiece
Advisory committee
DE
Contact
David Yoskowitz
K number
K232917
State
NJ
Date received
2023-09-19
Review advisory committee
DE
Postal code
07624
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Intraoral Cooling Device
Medical specialty description
Dental
Regulation number
872.5590
Device class
2
Registration number
3004906872, 3005977121, 3015177652, 3014426939
FEI number
3004906872, 3005977121, 3015177652, 3014426939
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.