FDA.report

Degunorm®

Primary DI
D00113080900
Brand
Degunorm®
Company
Dentsply International Inc.
Model
Laser Wire .70
Catalog number
1308090
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EJTALLOY, GOLD-BASED NOBLE METAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJTAlloy, Gold-Based Noble MetalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D00113080900PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental soldering alloyA mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Weight1.2Gram

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentspl
+1(800)243-1942Prosthetics-Regulatory@dentsplysirona.com

Regulatory Flags

DUNS number
606173334
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21
D0013010321Ceramco® 3Powder Opaque Modifier Sienna3010322016-09-21
D0013010361Ceramco® 3Powder Opaque Modifier Pink3010362016-09-21
D0013010371Ceramco® 3Powder Opaque Modifier Ochre3010372016-09-21
D0013010481Ceramco® 3Paste Opaque A3.53010482016-09-21
D0013010591Ceramco® 3Paste Opaque C23010592016-09-21
D0013010701Ceramco® 3Paste Opaque Modifiers White3010702016-09-21
D0013011031Ceramco® 3Opaceous Dentin i13011032016-09-21
D0013011071Ceramco® 3Opaceous Dentin A3.53011072016-09-21
D0013011101Ceramco® 3Opaceous Dentin i63011102016-09-21
D0013011181Ceramco® 3Opaceous Dentin C23011182016-09-21
D0013011221Ceramco® 3Opaceous Dentin D33011222016-09-21
D0013011501Ceramco® 3Dentin C43011502016-09-21
D0013011611Ceramco® 3Dentin Modifier A3.53011612016-09-21
D0013011671Ceramco® 3Dentin Modifier Blue3011672016-09-21
D0013012001Ceramco® 3Natural Enamel White3012002016-09-21
D0013012011Ceramco® 3Natural Enamel Extra Light3012012016-09-21
D0013013221Ceramco® 3Overglaze3013222016-09-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
97640173081831Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081848Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081855Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173081862Dentalor 60Cendres+Métaux SAEJT2024-07-01
97640173082036Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082043Solaro 4Cendres+Métaux SAEJT2024-07-01
97640173082050Solaro 4Cendres+Métaux SAEJT2024-07-01
00841549115684Stern 99STERNGOLD DENTAL LLCEJT2023-03-13
D818100057ARGEDENT 51SFARGEN CORPORATION, THEEJT2022-03-14
D818100061ARGEDENT 52ARGEN CORPORATION, THEEJT2022-03-14
D818100064ARGEDENT 52SFARGEN CORPORATION, THEEJT2022-03-14
D818100072ARGEDENT 74ARGEN CORPORATION, THEEJT2022-03-14
D818100075ARGEDENT 75ARGEN CORPORATION, THEEJT2022-03-14
D818100080ARGEDENT B 78PFARGEN CORPORATION, THEEJT2022-03-14
D818100120ARGENCO 10 GRAINARGEN CORPORATION, THEEJT2022-03-14
D818100131ARGENCO BIO 1ARGEN CORPORATION, THEEJT2022-03-14
D818100136ARGENCO 20ARGEN CORPORATION, THEEJT2022-03-14
D818100160ARGENCO 40ARGEN CORPORATION, THEEJT2022-03-14
D00153130803050Degutan®Dentsply International Inc.EJT2019-03-13
D7075797690Academy GoldIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797780Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797800Aquarius HardIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797940Academy Gold XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797970Aquarius XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075797990Aquarius XHIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798510HGPKF 1015 YIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798740BioUniversal PKFIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798760BioUniversal PKFIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798840Brite GoldIVOCLAR VIVADENT, INC.EJT2018-10-29
D7075798860Brite GoldIVOCLAR VIVADENT, INC.EJT2018-10-29