OAT · Class II · 21 CFR 872.3640

FDA Product Code OAT: Implant, Endosseous, Orthodontic

It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.

Leading manufacturers include Biomaterials Korea, Inc., Bomei Co, Ltd. and Synthes (Usa).

52
Total
52
Cleared
215d
Avg days
1998
Since
52 devices
25–48 of 52
Cleared Oct 03, 2012
ORTHOFIX SCREW
K113650
Bonafix Surgical and Dental Implants, LLC
Dental · 296d
Cleared Dec 14, 2011
PSM LOMAS / BENEFIT SCREWS
K110392
Psm Medical Solutions
Dental · 306d
Cleared Sep 26, 2011
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
K111809
Biomaterials Korea, Inc.
Dental · 91d
Cleared Jun 03, 2011
ORTHO EASY PIN
K110275
Forestadent Bernhard Forster GmbH
Dental · 123d
Cleared Mar 25, 2011
ORTHODONTIC SCREW
K103105
Osstem Implant Co., Ltd.
Dental · 156d
Cleared Dec 16, 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299
Synthes (Usa)
Dental · 421d
Cleared Mar 08, 2007
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473
Synthes (Usa)
Dental · 112d
Cleared Feb 09, 2007
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
K063386
Walter Lorenz Surgical, Inc.
Dental · 93d
Cleared Aug 16, 2006
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
K061397
Ace Surgical Supply Co., Inc.
Dental · 89d
Cleared Feb 03, 2006
STRAUMANN ORTHOSYSTEM
K060062
Institut Straumann AG
Dental · 25d
Cleared Apr 15, 2005
TOMAS PIN
K042965
Dentaurum, Inc.
Dental · 170d
Cleared Sep 30, 1998
ORTHO IMPLANT AND ACCESSORIES
K982509
Straumann USA
Dental · 72d