FDA.reportPublic FDA data

OpalCups Bristle

Primary DI
00883205020017
Brand
OpalCups Bristle
Company
ULTRADENT PRODUCTS, INC.
Model
5800
Catalog number
5800
Device description
OpalCups Bristle 20 pack
Published
2017-12-23
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
EHKCUP, PROPHYLAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205020017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205020017008832050200178832050200170883205020017

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, reusableA rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205004550ViscoStat ClearS646S6462018-04-28
00883205103192ViscoStat Clear641064102018-04-28
00883205103208ViscoStat Clear640964092018-04-28
00883205106889ViscoStat Clear640764072018-04-28
00883205106896ViscoStat Clear640864082018-04-28
00883205045775ClearTemp LC351835182026-04-28
00883205045782ClearTemp LCS3518S35182026-04-28
00883205045805Universal Dentin Sealant2662662026-04-28
00883205045904UltraSealS3529S35292026-04-28
00883205045911Peak Universal BondS4554S45542026-04-28
00883205045928Peak Universal BondS4551S45512026-04-28
00883205044990Porcelain Repair110811082026-03-28
00883205045003Porcelain Etch4054052026-03-28
00883205045010UltraSeal XT353235322026-03-28
00883205045027UltraSeal XT353335332026-03-28
00883205045034Peak Universal Bond454145412026-03-28
00883205045041Peak Universal Bond454245422026-03-28
00883205045058Peak Universal Bond455145512026-03-28
00883205045720Porcelain Etch101910192026-03-28
00883205042835Opalustre5545542026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850079280366CavexHexa DentalEHK2026-01-22
00850079280373CavexHexa DentalEHK2026-01-22
00850079280380CavexHexa DentalEHK2026-01-22
00883205032638OpalCupsULTRADENT PRODUCTS, INC.EHK2025-03-11
06975492100023PBCDONGGUAN YILONG MEDICAL SUPPLIES CO.. LTD.EHK2025-01-09
TQ26PA25523S0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
10302730003243Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003250Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003267Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003274Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003284Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003291Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00842517111578Karl SchumacherKarl Schumacher Dental, LLCEHK2024-03-01
00842517103214Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00842517103221Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00348783001181ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00348783004564ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00813360023424AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023431AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023448AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023455AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023462AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023479AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023486AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023493AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023509AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023516AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023523AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023530AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25