510(k) clearances

Silver Fluoride Hypersensitivity Varnish

Young Dental Manufacturing Co. 1, LLC · Dental

K241041Substantially EquivalentTraditionalPHR
Open FDA's page for this record
Third party flag
N
City
Earth City
Advisory committee description
Dental
Address 1
13705 Shoreline Ct. E.
Statement or summary
Summary
Product code
PHR
Zip code
63045
Applicant
Young Dental Manufacturing Co. 1, LLC
Decision date
2025-02-28
Decision code
SESE
Country code
US
Device name
Silver Fluoride Hypersensitivity Varnish
Advisory committee
DE
Contact
Brian Prange
K number
K241041
State
MO
Date received
2024-04-16
Review advisory committee
DE
Postal code
63045
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Medical specialty description
Dental
Regulation number
872.3260
Device class
2
Registration number
3014615644, 1941138, 3009603151, 3007113445, 3006444232, 1281412, 3027618252, 3020703838, 3003130442, 3004140838
FEI number
3014615644, 1941138, 3009603151, 3007113445, 3006444232, 1281412, 3027618252, 3020703838, 3003130442, 3004140838
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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.