DEVICE: Palodent® V3 Sectional Matrix System Designed by Triodent® (D002659770V1)
Device Identifier (DI) Information
Palodent® V3 Sectional Matrix System Designed by Triodent®
659770V
In Commercial Distribution
659770V
DENTSPLY INTERNATIONAL INC.
659770V
In Commercial Distribution
659770V
DENTSPLY INTERNATIONAL INC.
Palodent V3 Narrow Rings Refill
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? |
---|---|---|---|---|
45008 | Dental matrix band tensioner |
A hand-held, dental instrument designed for tightening a matrix band around a tooth that is being prepared for a dental restoration. It is a rod-like device, typically designed with a manually controlled rotating action at its distal end for insertion into and tightening of a retainerless matrix band around the tooth. When the matrix band is in place, this device is removed offering a clear field of vision. Some types may incorporate a torque control mechanism to limit over-tensioning. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZN | INSTRUMENTS, DENTAL HAND |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 2x Narrow Rings |
Device Record Status
fc6fd835-cf78-48fb-ad20-d05f7be98395
April 10, 2019
1
April 02, 2019
April 10, 2019
1
April 02, 2019
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:
D002659770V0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com