DEVICE: Diamond file A3 (04580406860775)
Device Identifier (DI) Information
Diamond file A3
Diamond file A3
In Commercial Distribution
46051
OSADA ELECTRIC CO.,LTD.
Diamond file A3
In Commercial Distribution
46051
OSADA ELECTRIC CO.,LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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46035 | Ultrasonic dental scaling/debridement system handpiece tip, endodontic |
An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to fragment and dislodge the debris within the dental pulp for removal during an endodontic procedure; it is not primarily intended for dental cleaning or periodontal therapy. Also referred to as an ultrasonic endodontic file or rasp, it is available in a 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 |
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ELC | Scaler, ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K844250 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8dda0a0f-338c-42c8-8dc5-4c5a73bc122a
February 21, 2019
4
September 20, 2016
February 21, 2019
4
September 20, 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
[?]
No Customer Contact currently defined