FDA.reportPublic FDA data

BluTab 2L Tablets

Primary DI
00850018182003
Brand
BluTab 2L Tablets
Company
PROEDGE DENTAL PRODUCTS, INC.
Model
BT20
Published
2020-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018182003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018182003008500181820038500181820030850018182003

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888433343richardv@proedgedental.com
18888433343coltonk@proedgedental.com

Regulatory Flags#

DUNS number
050414346
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018182041BluTube 180 Day Cartridge BT1802020-05-08
00850018182072BluTube 90 Day Cartridge BT902020-05-08
00850018182010BluTab 750mL TabletsBT50BT502020-04-20
00850018182089BluTube 180 Day Cartridge BT1802020-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832MTXA15021PlasdentPLASDENT CORPORATIONNRD2026-06-04
D832MTXA15031PlasdentPLASDENT CORPORATIONNRD2026-06-04
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
D678AS50X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
TQ26126171011Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263511Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26BC2263521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-20
TQ26126152121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152131Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152151Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152171Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152421Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152431Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26126152441Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26BC226111Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26BC226121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26BC226151Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26BC226161Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09
TQ26BC226171Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRD2024-12-09