DEVICE: SI-11 LED G, FRIADENT (J021329068501)
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Device Identifier (DI) Information
SI-11 LED G, FRIADENT
32906850
Not in Commercial Distribution
90-6850
W & H Dentalwerk Bürmoos GmbH
32906850
Not in Commercial Distribution
90-6850
W & H Dentalwerk Bürmoos GmbH
Surgical handpiece
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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 66245 | Dental surgical power tool motorized handpiece/set, electric |
An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KMW | Handpiece, Rotary Bone Cutting |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 35 Degrees Celsius |
| Storage Environment Humidity: between 8 and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f9732ae5-88d2-47dd-90ad-df68dd3f0ec1
August 08, 2024
6
September 29, 2016
August 08, 2024
6
September 29, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined