DEVICE: Bosworth Pit & Fissure (H6680921561)
Device Identifier (DI) Information
Bosworth Pit & Fissure
092156
In Commercial Distribution
092156
Harry J Bosworth Company
092156
In Commercial Distribution
092156
Harry J Bosworth Company
Pit & Fissure LC Sealant w Fluoride
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
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 |
---|
Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Storage Environment Temperature: between 32 and 86 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep away from moisture |
Special Storage Condition, Specify: Keep out of direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 1.2 Milliliter |
Device Record Status
0d250084-fa80-42d3-a7af-9442e3fe9a8b
March 29, 2018
2
September 15, 2016
March 29, 2018
2
September 15, 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:
H6680921560
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)333-3131
8455
tschwear@keystoneind.com
tschwear@keystoneind.com