Duns Number:113170088
Device Description: The ACCESS™ Cheek Retractors are intended for use in pulling the cheeks back from the bucc The ACCESS™ Cheek Retractors are intended for use in pulling the cheeks back from the buccal and labial surfaces of the teeth during orthodontic procedures. Adult Size - Special posterior pads comfortably hold the cheeks away and allow excellent "accessibility" to the bicuspid and molar area. Spring stainless steel bow allows for adjustment and pivot points provide greater comfort.
Catalog Number
CH1
Brand Name
ACCESS
Version/Model Number
CH1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
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
EIF
Product Code Name
Accessories, Retractor, Dental
Public Device Record Key
32a5d298-8319-43a6-83c8-00b18703ef31
Public Version Date
October 05, 2018
Public Version Number
3
DI Record Publish Date
July 25, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |