DEVICE: Henry Schein (H65810134660)
Device Identifier (DI) Information
Henry Schein
1013466
In Commercial Distribution
1013466
HENRY SCHEIN, INC.
1013466
In Commercial Distribution
1013466
HENRY SCHEIN, INC.
DNT BASE REPR LT CHAR SC (5 LBS 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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Weight: 5 Pound |
Device Record Status
3b2574d5-2bc8-4e46-9751-97727e15fe5d
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 |
---|---|---|---|---|---|
H65810134661 | 4 | H65810134660 | 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