DEVICE: Guardian Seal (10841396116527)
Device Identifier (DI) Information
Guardian Seal
31169
In Commercial Distribution
31169
Kerr Corporation
31169
In Commercial Distribution
31169
Kerr Corporation
Filled Pit and Fissure Sealant
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
31780 | Dental pit/fissure sealant |
A resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at ambient temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Weight: 4 Gram |
Device Record Status
b4cf87bb-8cd5-42cf-9ee5-3b7791067126
March 29, 2018
2
August 01, 2016
March 29, 2018
2
August 01, 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:
00841396116520
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+18005377123
customercare@kavokerrgroup.com
customercare@kavokerrgroup.com