Vintage MP/Vintage Art

Primary DI
E2359627TK0
Brand
Vintage MP/Vintage Art
Company
SHOFU DENTAL CORPORATION
Model
001
Catalog number
9627TK
Device description
One Shot Vintage MP Trial Kit. Contains DI's: E23596270, E23592600, E23592610, E23592680, E23592720, E23592760, E23565130, E23565140, E23565170, E23565260, E23565270, E23565280, E23565290
Published
2018-07-27
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E2359627TK0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
760-566-3528ckaemmerlen@shofu.com

Regulatory Flags

DUNS number
054618202
Device count
1
DM exempt
false
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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