DEVICE: V files (04560264562981)
Device Identifier (DI) Information
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
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| 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? |
|---|---|---|---|---|
| 64041 | Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusable |
A removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment/remove tissue during an endodontic procedure. It is available variety of forms and sizes, and is typically made of metal. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ELC | Scaler, ultrasonic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K991021 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
d1fcfbaa-81b5-4422-b924-81ceb4b86792
October 20, 2023
7
September 16, 2016
October 20, 2023
7
September 16, 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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
04560264565289
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined