FDA.reportPublic FDA data

AllPro

Primary DI
00813360020850
Brand
AllPro
Company
Cordica Medical, Inc.
Model
402 (Latch Mandel)
Catalog number
402-P-144
Device description
Prophy Cup, Latch Mandrel, Rib & Web, Pink Strawberry
Published
2022-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00813360020850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813360020850008133600208508133600208500813360020850

GMDN Terms#

Term, Definition table
TermDefinition
Dental polishing cup, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
078550672
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10813360023667UnoDoseUD45-PINK-BULK504462026-10-06
20813360023664UnoDoseUD45-PINK-BELMAR506162026-10-06
30813360023661UnoDoseUD45-PINK500012026-10-06
00813360022076DoselogixTCPERL017550132022-09-07
00813360022083DoselogixTC35 White7551682022-09-07
00813360022106DoselogixTC35 Purple7551702022-09-07
00813360022113DoselogixTC35 Red7551712022-09-07
00813360022120DoselogixTC35 Black7551722022-09-07
00813360022137DoselogixTC35 Green7551732022-09-07
00813360022144DoselogixTC35 Gold7551742022-09-07
00813360022151DoselogixTC35 Silver7551752022-09-07
00813360022168DoselogixTC35 Orange7551762022-09-07
00813360022175DoselogixTC35ORTUBE-WHITE7551782022-09-14
00813360022182DoselogixTC35 ALL ORANGE7551792022-09-14
00813360022199DoselogixTC9-A-BLUE7551842022-09-14
00813360022205DoselogixTC9-A-PINK7551852022-09-14
00813360022212DoselogixTC9-A-BLACK7551862022-09-14
00813360022229DoselogixTC9-A-GOLD7551872022-09-14
00813360022236DoselogixTC9-A-SILVER7551882022-09-14
00813360022243DoselogixTC9-A-PURPLE7551892022-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00883205026286Ultrapro TxULTRADENT PRODUCTS, INC.EHK2026-08-22
00840456220474JMUJMU DENTAL, INCEHK2026-07-07
00840456220481JMUJMU DENTAL, INCEHK2026-07-07
00840456220498JMUJMU DENTAL, INCEHK2026-07-07
00840456220504JMUJMU DENTAL, INCEHK2026-07-07
00840456220115JMUJMU DENTAL, INCEHK2026-06-25
00840456220122JMUJMU DENTAL, INCEHK2026-06-25
00840456220139JMUJMU DENTAL, INCEHK2026-06-25
00840456220146JMUJMU DENTAL, INCEHK2026-06-25
00840456220153JMUJMU DENTAL, INCEHK2026-06-25
00840456220160JMUJMU DENTAL, INCEHK2026-06-25
00840456220177JMUJMU DENTAL, INCEHK2026-06-25
00840456220184JMUJMU DENTAL, INCEHK2026-06-25
00840456220191JMUJMU DENTAL, INCEHK2026-06-25
00840456220207JMUJMU DENTAL, INCEHK2026-06-25
00840456220214JMUJMU DENTAL, INCEHK2026-06-25
00840456220221JMUJMU DENTAL, INCEHK2026-06-25
00840456220238JMUJMU DENTAL, INCEHK2026-06-25
00840456220245JMUJMU DENTAL, INCEHK2026-06-25
00840456220252JMUJMU DENTAL, INCEHK2026-06-25
00840456220269JMUJMU DENTAL, INCEHK2026-06-25
00840456220276JMUJMU DENTAL, INCEHK2026-06-25
07897990300103PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300110PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300127PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300219PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300233PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300264PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300271PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18
07897990300288PROPHY BRUSHESTDV DENTAL LTDAEHK2026-05-18