FDA.report

Novacryl Self Curing Acrylic B4 X 125g

Primary DI
07701126607939
Brand
Novacryl Self Curing Acrylic B4 X 125g
Company
PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A
Model
0017896
Catalog number
0017896
Device description
Novacryl Self Curing Acrylic B4 X 125g
Published
2017-05-23
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

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07701126607939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07701126607939077011266079397701126607939

GMDN Terms

TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
880141023
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07701126901211Portux 3D Printing Resin SG x 1000g0027364 0027364 2025-08-11
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07701126626343O-Cryl Self Curing Acrylic Shade Clear X 1 lb002319400231942024-05-08
07701126626350O-Cryl Self Curing Acrylic Liquid X 8 oz002319600231962024-05-08
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