510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901257Substantially Equivalent

Wirontom Clasp Wire

Ivoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901257 is the FDA 510(k) clearance record for WIRONTOM CLASP WIRE, a class I device, cleared for Ivoclar North America, Inc. on under FDA product code EJW (Clasp, Wire). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K901257.

Clearance record

Decision date
Received
(41 days to decision)
Product code
EJW Clasp, Wire
Regulation
21 CFR 872.3285
Device class
Class I
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code EJW

Trailing 12 months

FDA records hold no clearances under product code EJW in the trailing twelve months.

FDA records show no clearances under product code EJW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260