AccessGUDID - DEVICE: Embrace Wetbond Pit and Fissure Sealant (D701EMSWB2)

GUDID

Device Identifier (DI) Information

Brand Name: Embrace Wetbond Pit and Fissure Sealant
Version or Model: EMSWB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701EMSWB2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: Bulk Pack: 20 x 1.2 mL syringes, off white-shade shade + 100 applicator tips 36.6% filled

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?
31780	Dental pit/fissure sealant	A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBC	Sealant, Pit And Fissure, And Conditioner

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020287	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.2 Milliliter

Device Record Status

Public Device Record Key: 0569bfb1-c3ab-4cde-9d5f-b60deea50e27
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 28, 2016