DEVICE: Henry Schein (H65810183330)
Device Identifier (DI) Information
Henry Schein
1018333
In Commercial Distribution
1018333
HENRY SCHEIN, INC.
1018333
In Commercial Distribution
1018333
HENRY SCHEIN, INC.
ACR MON #3 SC (8 OZ 4 PER CASE)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16730 | Dental appliance fabrication material, resin |
A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
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 16 and 26 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 8 Fluid Ounce |
Device Record Status
4b4c8b88-0672-48c1-ae16-5875d0dabad7
November 10, 2021
4
September 24, 2016
November 10, 2021
4
September 24, 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 |
---|---|---|---|---|---|
H65810183331 | 4 | H65810183330 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined