DEVICE: NA (M595S8150)
Device Identifier (DI) Information
NA
S815
Not in Commercial Distribution
S815
PARKELL, INC.
S815
Not in Commercial Distribution
S815
PARKELL, INC.
500ml Bottle of Bonding Liner for Acrylic Solder
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
17609 | Denture reliner, hard |
A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.
|
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: less than 86 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep containers tightly closed in a dry, cool and well-ventilated place. Store away from heat. Do NOT store under pure nitrogen or oxygen-free gas. Protect from direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
23ea747f-5caf-464d-a5e7-2daa1dfb2f15
April 01, 2019
4
September 23, 2016
April 01, 2019
4
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
6312491134
customerservice@parkell.com
customerservice@parkell.com