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510(k) K261888

Device
ClearClub Impression Material
Applicant
ClearClub
510(k) number
K261888
Product code
SHI
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-16
Date received
2026-06-05
Regulation
872.3660
Classification name
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Pablo Osorio
Address
8915 S La Cienega Blvd. Suite A Inglewood CA US 90301 90301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SHI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251926enCore Impression MaterialEncore Guards2026-03-17
K251724Remi Impression MaterialGrindguard, Inc.2026-02-25