FDA.reportPublic FDA data

CHROMASURGE

Primary DI
D8328020A1
Brand
CHROMASURGE
Company
PLASDENT CORPORATION
Model
8020A
Catalog number
8020A
Device description
"CHROMA Surgical Tips, 1/8"", Assorted "
Published
2022-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8328020A1PrimaryHIBCC0
D8328020A0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Regulatory Flags#

DUNS number
190377184
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832BEE0001PlasdentBEE-000BEE-0002026-05-06
D832BEE0011PlasdentBEE-001BEE-0012026-05-06
D832BEE0021PlasdentBEE-002BEE-0022026-05-06
D832906CDG20Plasdent906CDG2906CDG22026-05-01
D832906CDG30Plasdent906CDG3906CDG32026-05-01
D832BLT1011PlasdentBLT-101BLT-1012026-05-01
D832BLT2001PlasdentBLT-200BLT-2002026-05-01
D832BLT2011PlasdentBLT-201BLT-2012026-05-01
D832BLT3001PlasdentBLT-300BLT-3002026-05-01
D832BLT3011PlasdentBLT-301BLT-3012026-05-01
D832BLT3021PlasdentBLT-302BLT-3022026-05-01
D832BLT4181PlasdentBLT-418BLT-4182026-05-01
D832BLT4201PlasdentBLT-420BLT-4202026-05-01
D832BLT4211PlasdentBLT-421BLT-4212026-05-01
D832BLT4221PlasdentBLT-422BLT-4222026-05-01
D832BLT4231PlasdentBLT-423BLT-4232026-05-01
D832BLT4251PlasdentBLT-425BLT-4252026-05-01
D832BLT4271PlasdentBLT-427BLT-4272026-05-01
D832BLT5221PlasdentBLT-522BLT-5222026-05-01
D832BLT522B1PlasdentBLT-522BBLT-522B2026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347018448Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
TQ26ST2553121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553411Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553621Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553921Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
10889950144838Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144845Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144852Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144869Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144876Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144883Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10888277652941MedlineMEDLINE INDUSTRIES, INC.EHZ2024-01-24
D248B101051Saliva Ejector Tip (Gray) - Pack of 10HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101081Saliva Ejector Tip (Gray) - Pack of 3HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101120Serviceable Saliva EjectorHAGER WORLDWIDE, INC.EHZ2023-09-12
10889950140717HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
10889950140724HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20