Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.
Listings on file with FDA
Device Name
Product Code
Status
Last Validated
Point, Paper, Endodontic
EKN
Valid
February 18, 2025
Device Listing
Device Name
Point, Paper, Endodontic
Product Code
EKN
Company Function(s)
Manufacturer
Proprietary Name(s)
ACEONE-ENDO
Knife, Margin Finishing, Operative
EJZ
Valid
February 18, 2025
Device Listing
Device Name
Knife, Margin Finishing, Operative
Product Code
EJZ
Company Function(s)
Manufacturer
Proprietary Name(s)
GP Trimmer
Gutta-Percha
EKM
Valid
February 18, 2025
Device Listing
Device Name
Gutta-Percha
Product Code
EKM
Company Function(s)
Manufacturer
Proprietary Name(s)
ACEONE-ENDO
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