FDA.report

Polyjel® NF™ Elastic Polyether Impression Material

Primary DI
D0026181101
Brand
Polyjel® NF™ Elastic Polyether Impression Material
Company
DENTSPLY INTERNATIONAL INC.
Model
618110
Catalog number
618110
Device description
Polyjel® NF™ Elastic Polyether Impression Material, 10 base and 10 catalyst, Bulk
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026181101PrimaryHIBCC0
D0026181100Unit of UseHIBCC0

GMDN Terms

TermDefinition
Polyether dental impression materialAn elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Weight200Gram
Weight1300Gram

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
083235549
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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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