FDA.reportPublic FDA data

Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules

Primary DI
D00265628621
Brand
Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules
Company
DENTSPLY INTERNATIONAL INC.
Model
656-2862
Catalog number
656-2862
Device description
Dispersed Phase Alloy, Fast Set, 2 Spill, 500 (600mg) Blue/White caps
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJJAlloy, amalgam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJJAlloy, AmalgamDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00265628622PackageHIBCC10Not in Commercial Distribution
D00265628621PrimaryHIBCC0
D00265628620Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam alloyA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight600Milligram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
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D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D662070900258PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900266PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900373PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900381PD SPHERICALSDI LIMITEDEJJ2026-02-17
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