Features:
Niti Open Springs
Delivers continuous force for opening or holding of spaces between teeth
Length: 914 mm/ 3 feet
Dia Size options:
0.010 ,0.012
FDA Statement
The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies.
If so, do not bid on this item unless you are an authorized purchaser.
If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item.
510(K) Number: K192233
Regulation Number: 21 CFR 872.6070
Product Code: EBZ
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
FDA for Scaler:
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS