Duns Number:657693730
Device Description: OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titaniu OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and pre-prosthetics appliances, in order to facilitate the orthodontic movement of teeth.OBS Anchorage Screw is available in the following diameter and length.• Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm )• Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) There are three types of OBS Anchorage Screw.• Square collar mushroom head none hole• Square collar mushroom head round hole• Square collar mushroom head slot holeOBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.The sterilization recommendations documented in the instructions for use (IFU) are according to “AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities” have been validated.Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.
Catalog Number
BD-2012-0
Brand Name
OBS Anchorage Screw
Version/Model Number
BD-2012-0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OAT
Product Code Name
Implant, Endosseous, Orthodontic
Public Device Record Key
b53899f2-096b-46ae-9efb-bf5449f044d3
Public Version Date
October 18, 2021
Public Version Number
5
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 42 |