FDA.reportPublic FDA data

DFV Desensitizing Varnish (Wonderful Varnish) Chocolate

Primary DI
D801SP70231
Brand
DFV Desensitizing Varnish (Wonderful Varnish) Chocolate
Company
SCIENTIFIC PHARMACEUTICALS, INC.
Model
70-23
Catalog number
70-23
Device description
DFV Desensitizing Varnish (Wonderful Varnish), Chocolate flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Published
2022-01-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192381000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192381000DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow FlavorScientific Pharmaceuticals2020-02-18LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D801SP70231PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cavity varnishA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9095959922Denise@scipharm.com

Regulatory Flags#

DUNS number
096010525
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D801ID70125BI1International Dental Supply Gel Etch Dental ConditionerID 70-125 BI70-1252016-08-11
D801SP50013B1SciPharm Dental Etching Agent BottleSP 50-013 B50-0132016-07-06
D801SP50013N1SciPharm Dental Etching Agent Bottle, Non-BoxedSP 50-013 N50-0132016-07-07
D801SP701211SciPharm Gel Etch Dental ConditionerSP 70-12170-1212016-08-11
D801SP70125B1SciPharm Gel Etch Dental ConditionerSP 70-125 B70-1252016-08-11
D801SP70125N1SciPharm Gel Etch Dental ConditionerSP 70-125 N70-1252016-08-11
D801SP70125RB1SciPharm Gel Etch Dental ConditionerSP 70-125 RB70-1252016-08-11
D801SP70125SB1SciPharm Gel Etch Dental ConditionerSP 70-125 SB70-1252016-08-11
D801SP70128B1SciPharm Gel Etch Dental ConditionerSP 70-125 B70-1282016-08-11
D801SP7012B1SciPharm Gel Etch Dental ConditionerSP 70-12 B70-122016-08-10
D801SP7012N1SciPharm Gel Etch Dental ConditionerSP 70-12 N70-122016-08-10
D801SP7012RB1SciPharm Gel Etch Dental ConditionerSP 70-12 RB70-122016-08-10
D801SP7012SB1SciPharm Gel Etch Dental ConditionerSP 70-12 SB70-122016-08-10
D801SP70130B1SciPharm Gel Etch Dental ConditionerSP 70-130 B70-1302016-08-11
D801SP70130N1SciPharm Gel Etch Dental ConditionerSP 70-130 N70-1302016-08-11
D801SP70143B1SciPharm Gel Etch Dental ConditionerSP 70-143 B70-1432016-08-11
D801SP70143N1SciPharm Gel Etch Dental ConditionerSP 70-143 N70-1432016-08-11
D801SP7014B1SciPharm Gel Etch Dental ConditionerSP 70-14 B70-142016-08-11
D801SP7014N1SciPharm Gel Etch Dental ConditionerSP 70-14 N70-142016-08-11
D801SP5505B1SciPharm Diamond Luster Polishing PasteSP 55-05 B55-052016-08-08

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