FDA.reportPublic FDA data

IMPRESS-RITE HP MIXING TIPS

Primary DI
00818524020493
Brand
IMPRESS-RITE HP MIXING TIPS
Company
CROWN DELTA CORPORATION
Model
VPS-8104
Catalog number
VPS-8104
Device description
M&S DENTAL IMPRESS-RITE HP MIXING TIPS (GREEN - 6.5MM) 48/BAG
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EIDSyringe, Restorative And Impression Material
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818524020490PackageGS148In Commercial Distribution
00818524020493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081852402049010818524020490
00818524020493008185240204938185240204930818524020493

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030479000
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818524020721PerectoDW642026-04-22
00818524020714EVOLVE KoR10-1015A10-1015A2023-09-21
00818524020370IMPRESS-RITE T-MIXING TIPSIMP-8104TIMP-8104T2019-10-29
00818524020417IMPRESS-RITE T-MIXING TIPSIMP-8105TIMP-8105T2019-10-29
00818524020455IMPRESS-RITE T-MIXING TIPSIMP-8106TIMP-8106T2019-10-29
00818524020547IMPRESS-RITE HP MIXING TIPSVPS-8120VPS-81202019-10-07
00818524020608IMPRESS-RITE T-MIXING TIPSVPS-8108TVPS-8108T2020-02-04
00818524020660IMPRESS-RITE T-MIXING TIPSVPS8150TVPS8150T2020-12-14
00818524020691IMPRESS-RITE HP-MIXING TIPSIMP-8140IMP-81402020-12-22
00818524020080ROOT LABS - TIPSRL500RL5002017-05-01
00818524020097ROOT LABS - MIXING TIPSRL510RL5102017-05-01
00818524020158ROOT LABS - MIXING TIPSRL850RL8502017-05-01
00818524020165ROOT LABS - DISPENSERRL762RL7622017-05-01
00818524020479IMPRESS-RITE HP MIXING TIPSVPS-8105VPS-81052017-07-05
00818524020486IMPRESS-RITE HP MIXING TIPSVPS-8106VPS-81062017-07-05
00818524020509IMPRESS-RITE INTRA-ORAL TIPSVPS-8103VPS-81032017-07-05
00818524020516IMPRESS-RITE INTRA-ORAL TIPSVPS-8101VPS-81012017-07-05
00818524020561IMPRESS-RITE DISPENSERVPS-8201VPS-82012017-07-05
00818524020639IMPRESS-RITEIMP-8140IMP-81402017-07-05
00818524020707IMPRESS-RITE HP-MIXING TIPSIMP-8140IMP-81402020-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00304040194416Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194423Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194430Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00304040194447Henry ScheinHENRY SCHEIN, INC.ELW2026-07-20
00840456200940JMUJMU DENTAL, INCEID2026-07-20
00840456216743JMUJMU DENTAL, INCEID2026-07-20
00840456218198JMUJMU DENTAL, INCEID2026-07-20
00840456218204JMUJMU DENTAL, INCEID2026-07-20
07506338322638VIVID JELMDC DENTALELW2026-07-20
07506338322645VIVID JELMDC DENTALELW2026-07-20
07506338322652VIVID JELMDC DENTALELW2026-07-20
07506338322669BLU JELMDC DENTALELW2026-07-20
07506338322676BLU JELMDC DENTALELW2026-07-20
07506338322690VIVID JELMDC DENTALELW2026-07-20
07615208474398Clinical Auxiliary (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2026-07-14
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
08809518346721Disposable TipMEDICLUS CO.,LTDEID2026-06-05
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28