FDA.reportPublic FDA data

ArgenPMMA Multi 98x16-A2

Primary DI
D818116256
Brand
ArgenPMMA Multi 98x16-A2
Company
ARGEN CORPORATION, THE
Model
116256
Catalog number
116256
Device description
Crown And Bridge, Temporary, Resin
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D818116256PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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
false
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

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Primary DI, Brand, Company table
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