DEVICE: Bonita Pit and Fissure Sealant (D820BONOW0)
Device Identifier (DI) Information
Bonita Pit and Fissure Sealant
1.2 mL Opaque White
In Commercial Distribution
BONOW
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution
BONOW
DENALI CORPORATION
Pit and Fissure Sealant, Dental.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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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 [?] |
---|---|
K071158 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3d8ddd66-3e72-4ca4-81ba-e048ee6453f5
July 06, 2018
3
August 05, 2016
July 06, 2018
3
August 05, 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 |
---|---|---|---|---|---|
D820BONOW1 | 4 | D820BONOW0 | In Commercial Distribution |
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
[?]
+1-781-826-9190
denalicorp@denalicorporation.com
denalicorp@denalicorporation.com