DEVICE: Power Slot (D798LED11MMP0)

Device Identifier (DI) Information

Power Slot
LED11MMP
Not in Commercial Distribution
LED11MMP
RELIANCE ORTHODONTIC PRODUCTS INC
D798LED11MMP0
HIBCC
December 21, 2017
1
113170088 *Terms of Use
11 mm LED Power Slot
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48101 Dental photo-activated disinfection system handpiece light guide
A detachable component of a dental photo-activated disinfection system that is attached to the distal end of the system's handpiece and designed to guide and transmit the photo-activating light from the handpiece into the hard and soft tissue within the oral cavity as part of the bacteria-eliminating process. The device is typically a rigid, curved tube containing a fibreoptic core and is sterilized between patients. It can be used without the attachment of a dedicated tip when larger tissue areas are to be treated. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ECP Instrument, Ligature Tucking, Orthodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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

44c49ac4-1976-49a2-b4b4-377fa9c49b7b
March 29, 2018
2
September 20, 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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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