FDA.reportPublic FDA data

SciPharm Luster Polishing Paste

Primary DI
D801SP50051
Brand
SciPharm Luster Polishing Paste
Company
SCIENTIFIC PHARMACEUTICALS, INC.
Model
SP 50-05
Catalog number
50-05
Device description
Dental Polishing Paste for Composite Restoratives, Amalgams, and Castings.
Published
2016-07-08
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
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842403000LUSTER, DENTAL POLISHING PASTEScientific Pharmaceuticals, Inc.1984-08-17EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D801SP50051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. 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
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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