FDA.reportPublic FDA data

RC-Prep

Primary DI
00348783001211
Brand
RC-Prep
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
900-7135
Device description
RC-Prep 9g Syringe box of 1 (Pack of 10) - China
Published
2023-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKQPreparer, Root Canal Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKQPreparer, Root Canal EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783001228PrimaryGS10
00348783001211Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783001228003487830012283487830012280348783001228
00348783001211003487830012113487830012110348783001211

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic reaming aid materialA liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Kit
true
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
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972902580024C-RootBeijing C-Root Dental Medical Devices Co., LTD.EKQ2026-06-10
TQ26126091141Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091181Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091241Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091381Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091401Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091421Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091441Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091461Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091471Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091481Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091491Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091501Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091511Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091531Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091541Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091551Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091561Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091571Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28
TQ26126091581Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EKQ2024-10-28