FDA.report

SIS (Luna)

Primary DI
08809458317041
Brand
SIS (Luna)
Company
Shinhung MST Co., Ltd.
Model
SPP40H
Device description
This product is used to implement fixture, abutment of oral cavity in impression acquisition and work model during dental implant procedure.
Published
2020-07-02
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
true

Related Records

Product Codes

CodeName
EGGAttachment, Precision, All

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809458317041PrimaryGS10

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
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82337301900syangt8823@shinhung.co.kr

Regulatory Flags

DUNS number
689667152
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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