DEVICE: Vintage Halo (E23577730)
Device Identifier (DI) Information
Vintage Halo
7773
In Commercial Distribution
7773
SHOFU DENTAL CORPORATION
7773
In Commercial Distribution
7773
SHOFU DENTAL CORPORATION
Vintage Halo Whitening 15g W30
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Dental prosthesis fabrication material, ceramic | A dental material made of ceramic materials e.g., zirconium oxide, intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is and is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EIH | Powder, Porcelain |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 1 and 30 Degrees Celsius |
Handling Environment Temperature: between 1 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0ceaffd6-aa14-4a0d-8315-5011346c95ef
March 29, 2018
2
September 25, 2016
March 29, 2018
2
September 25, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
760-566-3528
ckaemmerlen@shofu.com
ckaemmerlen@shofu.com