DEVICE: Henry Schein (00304040010532)

Device Identifier (DI) Information

Henry Schein
9011530
In Commercial Distribution
9011530
HENRY SCHEIN, INC.
00304040010532
GS1

1
012430880 *Terms of Use
Zirlux 16+ D4 100X18
CLOSE

Device Characteristics

MR Safe
No
No
Yes
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EIH POWDER, PORCELAIN
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141724 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Dry storage space
Storage Environment Temperature: between 0 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 100 Millimeter
CLOSE

Device Record Status

595686bb-3d1f-4d33-8d85-521ca80d4ea7
July 24, 2018
4
September 24, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE