DEVICE: Palodent® 360 (D0026596070)
Device Identifier (DI) Information
Palodent® 360
659607
In Commercial Distribution
659607
DENTSPLY INTERNATIONAL INC.
659607
In Commercial Distribution
659607
DENTSPLY INTERNATIONAL INC.
Palodent® 360 Intro Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
38786 | Dental matrix band, single-use |
A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use 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 |
---|
Special Storage Condition, Specify: Store at room temperature. |
Storage Environment Temperature: between 2 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep away from moisture or excessive humidity. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 48 Matrices (8 of 4.5mm, 24 of 5.5mm, 16 of 6.5mm) |
Device Record Status
b69caf77-5156-491f-a0de-09be12b1b66b
August 24, 2022
1
August 16, 2022
August 24, 2022
1
August 16, 2022
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
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com