Home / 510(k) Clearances / K872622

510(k) K872622

ORTHODONTIC ARCH by Wonder Wire — Product Code EJZ

K872622 is an FDA 510(k) premarket notification submitted by Wonder Wire for the device "ORTHODONTIC ARCH". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code EJZ (Knife, Margin Finishing, Operative), a Class I device regulated under 21 CFR 872.4565. Wonder Wire has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
July 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Margin Finishing, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Wonder Wire

  • K931631 — COATED ORTHODONTIC DEVICES (July 28, 1993)

Other clearances for product code EJZ

  • K823315 — DENTAL INSTRUMENTS - KNIVES (November 24, 1982)

FDA data resources