FDA.reportPublic FDA data

SciPharm Diamond Luster Polishing Paste

Primary DI
D801SP5505N1
Brand
SciPharm Diamond Luster Polishing Paste
Company
SCIENTIFIC PHARMACEUTICALS, INC.
Model
SP 55-05 N
Catalog number
55-05
Device description
Diamond Luster Polishing Paste Syringe for Dental Ceramics. Non-Boxed.
Published
2016-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K873686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873686000DIAMOND-LUSTER DENTAL POLISHING PASTEScientific Pharmaceuticals, Inc.1987-11-12EJR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D801SP5505N1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive powderA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of implants prior to loading. This is a single-use device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
TQ26126191191Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191231Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191251Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191271Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191291Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191331Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191351Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31