FDA.report

FRIADENT®

Primary DI
EFRI324696402
Brand
FRIADENT®
Company
Dentsply Implants Manufacturing GmbH
Model
32469640
Catalog number
46-9640
Device description
MP Lab Set Gold Bar Coping D3.8
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFRI324696402PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Storage, in the original packaging, at room temperature in a dry place away from sunlight.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)531-3481implants-na-cs@dentsply.com
+1(800)531-3481implants-na-cs@dentsplysirona.com

Regulatory Flags

DUNS number
344038836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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