MTAFlow Gel 2.0 g (Version 2)

Primary DI
00850008515194
Brand
MTAFlow Gel 2.0 g (Version 2)
Company
NUSMILE, LTD.
Model
14083
Device description
Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.
Published
2020-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850008515194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850008515194008500085151948500085151940850008515194

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
185497372
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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