DEVICE: ProSeal (D798LEDPRO0)
Device Identifier (DI) Information
ProSeal
LEDPRO
In Commercial Distribution
LEDPRO
RELIANCE ORTHODONTIC PRODUCTS INC
LEDPRO
In Commercial Distribution
LEDPRO
RELIANCE ORTHODONTIC PRODUCTS INC
LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets.
LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a Reliance Black Light or a simple portable (UV) light.
Cures using a 468nm LED Light.
6ml bottle LED ProSeal
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 |
---|---|
EBD | Coating, Filling Material, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K073243 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 degrees C) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
acf08673-5a20-48dc-acff-9f68933b6a8d
July 06, 2018
3
August 03, 2016
July 06, 2018
3
August 03, 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 |
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No Package DIs found |
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
[?]
630-773-4009
paulgropi@aol.com
paulgropi@aol.com