AccessGUDID - DEVICE: EMBRACE VARNISH - 5% SODIUM FLUORIDE WITH CXP™ (D701FV502)

GUDID

Device Identifier (DI) Information

Brand Name: EMBRACE VARNISH - 5% SODIUM FLUORIDE WITH CXP™
Version or Model: FV50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701FV502
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: 50 x 0.4 mL Embrace Varnish unit dose with applicator brush

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?
35698	Dental cavity varnish	A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	Varnish, Cavity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.4 Milliliter

Device Record Status

Public Device Record Key: f4bbfae9-8a4f-45c9-b3fb-fb0d731d115a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 21, 2016