FDA.report

ARGEN

Primary DI
D818132653
Brand
ARGEN
Company
ARGEN CORPORATION, THE
Model
132653
Catalog number
132653
Device description
ArgeResin Flx Splint 1kg
Published
2022-09-26
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

Related Records

Product Codes

CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D818132653PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods

Method

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
true
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
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

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06974361422556Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
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06974361423058Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
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06974361423072Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
06974361423089Zhejiang YinchiliZhejiang Yinchili Medical Technology Co., Ltd.KMY2026-03-23
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03770020010170FroggymouthBIOTECH DENTAL SMILERSKMY2026-03-17
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