FDA.report

digit Power™ Dispenser

Primary DI
D0026780610
Brand
digit Power™ Dispenser
Company
DENTSPLY INTERNATIONAL INC.
Model
678061
Catalog number
665790
Device description
digit Power Dispenser Kit - MIDWEST
Published
2019-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EHZEvacuator, oral cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026780610PrimaryHIBCC0

GMDN Terms

TermDefinition
Two-component dental material applicator, pneumaticA non-sterile, pneumatic device intended to dispense a two-component dental material (e.g., impression material) from a cartridge directly into the mouth or into another device (e.g., impression tray). It typically has an air regulator portion connected to a handpiece with a cartridge plunging mechanism; typically a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@den
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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