DEVICE: iSmile (00816419021396)
Device Identifier (DI) Information
iSmile
20-0105
In Commercial Distribution
20-0105
Ismile Dental Products, Inc.
20-0105
In Commercial Distribution
20-0105
Ismile Dental Products, Inc.
Pre-Bent Tip 25 gauge Blue
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
64403 | Root canal irrigation blunt needle |
A slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KYZ | Syringe, Irrigating (Non Dental) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f2192e68-9700-4f53-9f58-a40ad8bee650
June 29, 2023
1
June 21, 2023
June 29, 2023
1
June 21, 2023
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
20816419021390
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
916-928-0359
info@ismiledp.com
info@ismiledp.com