FDA.reportPublic FDA data

SciPharm Gel Etch Dental Conditioner

Primary DI
D801SP7012RB1
Brand
SciPharm Gel Etch Dental Conditioner
Company
SCIENTIFIC PHARMACEUTICALS, INC.
Model
SP 70-12 RB
Catalog number
70-12
Device description
Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Fluoridized Syringe. Boxed. Refill.
Published
2016-08-10
Public version status
Update
Distribution status
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K872569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872569000TEMREX ETCHING GELScientific Pharmaceuticals, Inc.1987-07-21EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D801SP7012RB1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Fahrenheit83 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-634-3047Denise@scipharm.com
909-595-9922Denise@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
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
D801SP5505N1SciPharm Diamond Luster Polishing PasteSP 55-05 N55-052016-08-08

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