DEVICE: Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules (D0026562621)

Device Identifier (DI) Information

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
656262
Not in Commercial Distribution
656262
DENTSPLY INTERNATIONAL INC.
D0026562621
HIBCC
August 01, 2021
500
083235549 *Terms of Use
Dispersed Phase Alloy, Fast Set, 2 Spill, 2000 (600mg) Blue/White caps
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
34836 Dental amalgam alloy
A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJJ Alloy, amalgam
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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: Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
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Clinically Relevant Size

[?]
Size Type Text
Weight: 600 Milligram
Device Size Text, specify: Fast Set, 2 Spill, 4 cartons of 500 (600mg) Blue/White caps
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Device Record Status

53627f92-1b20-4ae3-9dec-3641701ccffa
December 20, 2023
3
September 21, 2016
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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
D0026562622 4 D0026562621 2021-07-31 Not in Commercial Distribution Case
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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: D0026562620 CLOSE

Direct Marking (DM)

[?]
Yes
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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