AccessGUDID - DEVICE: Self Etching primer (D798SEPC0)

GUDID

Device Identifier (DI) Information

Brand Name: Self Etching primer
Version or Model: SEPC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SEPC
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798SEPC0
Issuing Agency: HIBCC
Commercial Distribution End Date: February 15, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36153	Dental etching solution	An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071688	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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