DEVICE: Palodent® 360 (D0026596070)

Device Identifier (DI) Information

Palodent® 360
659607
In Commercial Distribution
659607
DENTSPLY INTERNATIONAL INC.
D0026596070
HIBCC

1
083235549 *Terms of Use
Palodent® 360 Intro Kit
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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
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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
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.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 48 Matrices (8 of 4.5mm, 24 of 5.5mm, 16 of 6.5mm)
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Device Record Status

b69caf77-5156-491f-a0de-09be12b1b66b
August 24, 2022
1
August 16, 2022
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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: No Unit of Use DI Numbers Found 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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