Home / 510(k) Clearances / K951776

510(k) K951776

BAND SEATER by Ormco Corp. — Product Code ECR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1995
Date Received
April 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Setter, Band, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Ormco Corp.

  • K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM (December 5, 2014)
  • K123118 — INSIGNIA DIGICAST (March 26, 2013)
  • K123416 — INSIGNIA WITH ITERO (March 13, 2013)
  • K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (February 8, 2013)
  • K121524 — INSIGNIA (August 9, 2012)
  • K112640 — HYPERELASTIC WIRE (November 16, 2011)
  • K101676 — CLEARARCH (September 13, 2010)
  • K081900 — TEMPORARY TOOTH REPLACEMENT (October 24, 2008)
  • K081415 — DAMON 4CLEAR (September 24, 2008)
  • K062856 — TF ROTARY NICKEL TITANIUM FILE (December 13, 2006)

Other clearances for product code ECR

  • K935156 — DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS (February 3, 1994)
  • K843018 — FLEXI-POST (September 27, 1984)