DEVICE: ProSeal (D798LEDPRO0)

Device Identifier (DI) Information

ProSeal
LEDPRO
In Commercial Distribution
LEDPRO
RELIANCE ORTHODONTIC PRODUCTS INC
D798LEDPRO0
HIBCC

1
113170088 *Terms of Use
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
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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
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FDA Product Code

[?]
Product Code Product Code Name
EBD Coating, Filling Material, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K073243 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 degrees C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

acf08673-5a20-48dc-acff-9f68933b6a8d
July 06, 2018
3
August 03, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
630-773-4009
paulgropi@aol.com
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