FDA.reportPublic FDA data

APPLAUSE®

Primary DI
D001181200050
Brand
APPLAUSE®
Company
Dentsply International Inc.
Model
Alloy
Catalog number
18120005
Published
2017-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJSALLOY, OTHER NOBLE METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJSAlloy, Other Noble MetalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D001181200050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight31.1Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags#

DUNS number
606173334
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092172766CekaPreat CorporationEJS2023-12-21
00842092166611CekaPreat CorporationEJS2023-12-21
00842092112922CekaPreat CorporationEJS2023-11-02
00841549118289Platinum Foil 1 DWT STERNGOLD DENTAL LLCEJS2023-10-06
D772031325005000POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290010JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI070290020JUSTI PAKTO PURE ALLOYAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI290001K0JUSTI PAKTO PURE ALLOY AMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500010POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
D772ATI32500050POZZI MALIBU SILVER SOLDERAMERICAN TOOTH INDUSTRIESEJS2023-08-30
00843471101346The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
00843471101353The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
10843471101343The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
10843471101350The Orthodontic StoreYoung Innovations, Inc.EJS2022-11-24
06970469230253Aidite Firing PasteAidite (Qinhuangdao) Technology Co., Ltd.EJS2022-04-07
D818100025ARGEBOND 80ARGEN CORPORATION, THEEJS2022-03-14
D818100270ARGELITE 50ARGEN CORPORATION, THEEJS2022-03-14
D818100273ARGELITE 54+ARGEN CORPORATION, THEEJS2022-03-14
D818100275ARGELITE 54BARGEN CORPORATION, THEEJS2022-03-14
D818100278ARGELITE 55ARGEN CORPORATION, THEEJS2022-03-14
D818100280ARGELITE 58PARGEN CORPORATION, THEEJS2022-03-14
D818100286ARGELITE 60ARGEN CORPORATION, THEEJS2022-03-14
D818100291ARGELITE 61ARGEN CORPORATION, THEEJS2022-03-14
D818100296ARGELITE 75+6ARGEN CORPORATION, THEEJS2022-03-14
D818100305ARGELITE 76SF+ARGEN CORPORATION, THEEJS2022-03-14
D818100323ARGELITE PF+ARGEN CORPORATION, THEEJS2022-03-14
D818100540ARGELITE 80SF+ARGEN CORPORATION, THEEJS2022-03-14
D818101549ARGELITE 52+ARGEN CORPORATION, THEEJS2022-03-14
D818101555ARGELITE 49ARGEN CORPORATION, THEEJS2022-03-14
D818102525ARGISTAR 40ARGEN CORPORATION, THEEJS2022-03-14