FDA.reportPublic FDA data

LWT 720PF LW RL (1dwt)

Primary DI
D818111800
Brand
LWT 720PF LW RL (1dwt)
Company
ARGEN CORPORATION, THE
Model
111800
Catalog number
111800
Device description
Gold based noble metal
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJTAlloy, gold-based noble metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJTAlloy, Gold-Based Noble MetalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D818111800PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(858) 455-7900pcascone@argen.com

Regulatory Flags#

DUNS number
103095543
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D818138360Zimax ClassicUltra 98x121383601383602026-02-11
D818137839ArgenZ GT 98x12 A11378391378392026-01-15
D818137840ArgenZ GT 98x12 A21378401378402026-01-15
D818137841ArgenZ GT 98x12 A31378411378412026-01-15
D818137849ArgenZ GT 98x16 A11378491378492026-01-15
D818137850ArgenZ GT 98x16 A21378501378502026-01-15
D818137851ArgenZ GT 98x16 A31378511378512026-01-15
D818137859ArgenZ GT 98x20 A11378591378592026-01-15
D818137860ArgenZ GT 98x20 A21378601378602026-01-15
D818137861ArgenZ GT 98x20 A31378611378612026-01-15
D818137864ArgenZ GT 98x25 A11378641378642026-01-15
D818137865ArgenZ GT 98x25 A21378651378652026-01-15
D818137866ArgenZ GT 98x25 A31378661378662026-01-15
D818137874ArgenZ GT 98x12 B11378741378742026-01-15
D818137877ArgenZ GT 98x12 B41378771378772026-01-15
D818137882ArgenZ GT 98x16 B11378821378822026-01-15
D818137885ArgenZ GT 98x16 B41378851378852026-01-15
D818137890ArgenZ GT 98x20 B11378901378902026-01-15
D818137893ArgenZ GT 98x20 B41378931378932026-01-15
D818137894ArgenZ GT 98x25 B11378941378942026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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