DFV Desensitizing Varnish (Wonderful Varnish) Bubblegum (Tutti-Fruity) 70-21

GUDID D801SP70211

DFV Desensitizing Varnish (Wonderful Varnish), Bubblegum (Tutti-Fruity) flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental cavity varnish

Primary Device ID	D801SP70211
NIH Device Record Key	9e5a44c2-f1b0-4948-8c70-55537132c98b
Commercial Distribution Status	In Commercial Distribution
Brand Name	DFV Desensitizing Varnish (Wonderful Varnish) Bubblegum (Tutti-Fruity)
Version Model Number	70-21
Catalog Number	70-21
Company DUNS	096010525
Company Name	SCIENTIFIC PHARMACEUTICALS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com
Phone	9095959922
Email	Denise@scipharm.com

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP70211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192381

FDA Product Code

LBH	Varnish, Cavity

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-27
Device Publish Date	2022-01-19

Devices Manufactured by SCIENTIFIC PHARMACEUTICALS, INC.

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D801SP70211 - DFV Desensitizing Varnish (Wonderful Varnish) Bubblegum (Tutti-Fruity)	2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Bubblegum (Tutti-Fruity) flavor, is a fluoride-containing resin preparation for t
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D801SP70241 - DFV Desensitizing Varnish (Wonderful Varnish) Marshmallow	2022-01-27 DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containing resin preparation for the treatment
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