DEVICE: Vintage Halo (E23572160)

Device Identifier (DI) Information

Vintage Halo
7216
In Commercial Distribution
7216
SHOFU DENTAL CORPORATION
E23572160
HIBCC

1
054618202 *Terms of Use
HALO BODY POWDER 15G ROOT-CB
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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 appliance 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 used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.
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FDA Product Code

[?]
Product Code Product Code Name
EIH Powder, Porcelain
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K973247 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 1 and 30 Degrees Celsius
Handling Environment Temperature: between 1 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a9c5b9e7-7c9e-4019-a55a-a1600d327883
July 24, 2018
4
September 25, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
760-566-3528
ckaemmerlen@shofu.com
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