Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules 656262

GUDID D0026562622

Dispersed Phase Alloy, Fast Set, 2 Spill, 2000 (600mg) Blue/White caps

DENTSPLY INTERNATIONAL INC.

Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy
Primary Device IDD0026562622
NIH Device Record Key53627f92-1b20-4ae3-9dec-3641701ccffa
Commercial Distribution Discontinuation2021-08-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDispersalloy® Dispersed Phase Alloy Self-Activating Capsules
Version Model Number656262
Catalog Number656262
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count500
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0
Weight600 Milligram
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Storage temperature 25° Celcius/77° Fahrenheit. Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026562620 [Unit of Use]
HIBCCD0026562621 [Primary]
HIBCCD0026562622 [Package]
Contains: D0026562621
Package: Case [4 Units]
Discontinued: 2021-07-31
Not in Commercial Distribution

FDA Product Code

EJJAlloy, amalgam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-12-20
Device Publish Date2016-09-21

On-Brand Devices [Dispersalloy® Dispersed Phase Alloy Self-Activating Capsules]

D0026562932Dispersed Phase Alloy, Regular Set, 3 Spill, 2000 (800mg) Yellow/White caps
D0026562922Dispersed Phase Alloy, Regular Set, 2 Spill, 2000 (600mg) Blue/White caps
D0026562912Dispersalloy Dispersed Phase Alloy, Regular Set, 1 Spill, 2000 (400mg) Green/White caps
D0026562612Dispersed Phase Alloy, Fast Set, 1 Spill, 2000 (400mg) Green/White caps
D0026562622Dispersed Phase Alloy, Fast Set, 2 Spill, 2000 (600mg) Blue/White caps

Trademark Results [Dispersalloy]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DISPERSALLOY
DISPERSALLOY
72304837 0868727 Live/Registered
UNITEK CORPORATION
1968-08-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.