FDA.report

510(k) K230098

Device
Trusana?
Applicant
Myerson, LLC
510(k) number
K230098
Product code
EBI
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-13
Date received
2023-01-13
Regulation
872.3760
Classification name
Resin, Denture, Relining, Repairing, Rebasing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
James H Swartout
Address
5106 N. Ravenswood Ave. Chicago IL US 60640 60640

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00842326199477TrusanaThe Myerson Company Limited2025-08-26
00842326199460TrusanaThe Myerson Company Limited2025-08-26
00842326199668Trusana1The Myerson Company Limited2025-02-28
00842326199651Trusana1The Myerson Company Limited2025-02-28
00842326199637Trusana1The Myerson Company Limited2025-02-28
00842326199569TrusanaThe Myerson Company Limited2023-10-27
00842326199552TrusanaThe Myerson Company Limited2023-10-03
00842326199545TrusanaThe Myerson Company Limited2023-10-03
00842326199453TrusanaThe Myerson Company Limited2023-09-14
00842326199446TrusanaThe Myerson Company Limited2023-09-14
00842326128422TrusanaThe Myerson Company Limited2023-08-11
00842326128415TrusanaThe Myerson Company Limited2023-08-11
00842326128408TrusanaThe Myerson Company Limited2023-08-11
00842326128392TrusanaThe Myerson Company Limited2023-08-11

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