Duns Number:113170088
Device Description: The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P College Kit – 1x S.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW 50 x Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD
Catalog Number
SEPC
Brand Name
Self Etching primer
Version/Model Number
SEPC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 2018
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
K071688
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
7a8ff8d1-6a24-4f8b-8502-9287a3ae33a8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 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 |