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.
D002659770V1
HIBCC

2
083235549 *Terms of Use
Palodent V3 Narrow Rings Refill
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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
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FDA Product Code

[?]
Product Code Product Code Name
DZN INSTRUMENTS, DENTAL HAND
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2x Narrow Rings
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Device Record Status

fc6fd835-cf78-48fb-ad20-d05f7be98395
April 10, 2019
1
April 02, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D002659770V0 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
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