DEVICE: Wagotrix (00850028211427)
Device Identifier (DI) Information
Wagotrix
WGSMEK-B
In Commercial Distribution
WGSMEK-B
GoldenDent
WGSMEK-B
In Commercial Distribution
WGSMEK-B
GoldenDent
Wagotrix Sectional Matrix System Essential Kit, 3.5mm anatomical matrix refill - Qty 25, 4.5mm anatomical matrix refill - Qty 25, 5.5mm anatomical matrix refill - Qty 25, 6.5mm anatomical matrix refill - Qty 25, Wedge - small - Qty 25, Wedge - medium - Qty 25, Wedge - large - Qty 25, Matrix ring universal - Qty 10
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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62764 | Dental matrix band kit |
A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EKF | INSTRUMENT, CONTOURING, MATRIX, OPERATIVE |
EJB | HANDLE, INSTRUMENT, DENTAL |
JEP | RETAINER, MATRIX |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
07758024-5201-4485-9bd9-71a68f11f6f9
March 05, 2021
1
February 25, 2021
March 05, 2021
1
February 25, 2021
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