510(k) clearances

Remi Custom Night Guard

Grindguard, Inc. · Unknown

K243516Substantially EquivalentTraditionalMQC
Open FDA's page for this record
Third party flag
N
City
San Francisco
Advisory committee description
Unknown
Address 1
155 Jackson St.
Address 2
1206
Statement or summary
Summary
Product code
MQC
Zip code
94111
Applicant
Grindguard, Inc.
Decision date
2025-02-10
Decision code
SESE
Country code
US
Device name
Remi Custom Night Guard
Contact
Oscar Adelman
K number
K243516
State
CA
Date received
2024-11-13
Review advisory committee
DE
Postal code
94111
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mouthguard, Prescription
Medical specialty description
Unknown
Device class
U
Registration number
3030515618, 2032273, 3005350578, 8030452, 3020749939, 1483306, 1036212, 3005730680, 2280629, 2032807, 2433919, 3014888923, 3004491043, 3022068322, 3009482106, 3017567754, 3009779268, 3012623144, 3009133124, 3011532731, 3030686055, 3007233968, 3002789526, 3030268763, 3025434480, 3014289665, 3003283852, 3024749697, 3009440973, 3013652641, 1719513, 2515379, 3010002722, 1723435, 3009727738, 3001295407, 3017520337, 8044058, 3008347275, 3043044356 +44 more
FEI number
3030515618, 3005350578, 3020749939, 1483306, 1036212, 3005730680, 3003943714, 2433919, 3014888923, 3004491043, 3022068322, 3009482106, 3017567754, 3009779268, 3012623144, 3000203342, 3009133124, 3011532731, 3030686055, 3007233968, 3002789526, 3030268763, 3003240904, 3025434480, 3014289665, 3003283852, 3024749697, 3009440973, 3013652641, 1719513, 2515379, 3010002722, 3009727738, 3001295407, 3017520337, 3008347275, 3043044356, 2916735, 3027494823, 3008320092 +44 more
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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.