DEVICE: Wooden Applicators (D798WA0)
Device Identifier (DI) Information
Wooden Applicators
WA
Not in Commercial Distribution
WA
RELIANCE ORTHODONTIC PRODUCTS INC
WA
Not in Commercial Distribution
WA
RELIANCE ORTHODONTIC PRODUCTS INC
Wooden Applicators are used to apply adhesive paste to any bracket or band surface.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38530 | Dental spatula, reusable |
A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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ECP | Instrument, Ligature Tucking, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at ambiet conditions. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2a0be3b2-cbe0-4359-9edb-4585f38c9476
December 21, 2018
4
July 25, 2016
December 21, 2018
4
July 25, 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