DEVICE: Henry Schein (H65810118100)
Device Identifier (DI) Information
Henry Schein
1011810
In Commercial Distribution
1011810
HENRY SCHEIN, INC.
1011810
In Commercial Distribution
1011810
HENRY SCHEIN, INC.
ACR MON #1 HC (QT 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? |
---|---|---|---|---|
16729 | Denture base resin, heat-cured |
A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device.
|
Obsolete | 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 |
---|
Total Volume: 1 Quart |
Device Record Status
3e14c5f0-1beb-4064-97e5-c0a841e8160d
March 29, 2018
2
September 24, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
H65810118101 | 4 | H65810118100 | In Commercial Distribution | CASE |
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
[?]
No Customer Contact currently defined