AccessGUDID - DEVICE: Self Etching Primer (D798SEPD0)

GUDID

Device Identifier (DI) Information

Brand Name: Self Etching Primer
Version or Model: SEPD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SEPD
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798SEPD0
Issuing Agency: HIBCC
Commercial Distribution End Date:
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 dispenser is intended to be used for the delivery of the primer in preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.

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:	No
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: store in ambient conditions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70768626-81aa-4dab-b7ae-c167de7ad387
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 01, 2016