Embrace Wetbond Pit and Fissure Sealant

Basic Information

• Brand Name: Embrace Wetbond Pit and Fissure Sealant
• Primary DI: D701EMS3W2
• Version / Model: EMS3W
• Company Name: PULPDENT CORPORATION
• Labeler DUNS: 001006089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 314c4769-e843-4326-a219-fd0086eca3fc

Device Description

3 mL syringe only, off-white shade 36.6% filled

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	872.3765	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D701EMS3W2	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K020287	000

Device Sizes

Type	Value	Unit	Text
Total Volume	3	Milliliter