FDA.reportPublic FDA data

IMPRESS-RITE HP MIXING TIPS

Primary DI
00818524020479
Brand
IMPRESS-RITE HP MIXING TIPS
Company
CROWN DELTA CORPORATION
Model
VPS-8105
Catalog number
VPS-8105
Device description
M&S DENTAL IMPRESS-RITE HP MIXING TIPS (YELLOW - 4.2MM) 48/BAG
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10818524020476PackageGS148In Commercial Distribution
00818524020479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081852402047610818524020476
00818524020479008185240204798185240204790818524020479

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
00818524020486IMPRESS-RITE HP MIXING TIPSVPS-8106VPS-81062017-07-05
00818524020493IMPRESS-RITE HP MIXING TIPSVPS-8104VPS-81042017-07-05
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
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20