FDA.reportPublic FDA data

NovaPro Flow

Primary DI
30816537020173
Brand
NovaPro Flow
Company
NANOVA BIO MATERIALS INC
Model
63118-12
Catalog number
63118-12
Device description
Flowable Composite Carpule - A2 Shade
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40816537020170PackageGS110In Commercial Distribution
30816537020173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4081653702017040816537020170
3081653702017330816537020173

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+1(573)875-6682support@nanovabio.com

Regulatory Flags#

DUNS number
006084093
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816537021698FiberFIX90723-12021-08-21
00816537021704FiberFIX90730-12021-08-21
00816537021711FiberFIX90735-12021-08-21
00816537021728FiberFIX90823-12021-08-21
00816537021735FiberFIX90830-12021-08-21
00816537021742FiberFIX90835-12021-08-21
00816537021759FiberFIX90923-12021-08-21
00816537021766FiberFIX90930-12021-08-21
00816537021773FiberFIX90935-12021-08-21
00816537021780FiberFIX91023-12021-08-21
00816537021797FiberFIX91030-12021-08-21
00816537021803FiberFIX91035-12021-08-21
00816537021810FiberFIX91123-12021-08-21
00816537021827FiberFIX91130-12021-08-21
00816537021834FiberFIX91135-12021-08-21
00816537021841FiberFIX91223-12021-08-21
00816537021858FiberFIX91230-12021-08-21
00816537021865FiberFIX91235-12021-08-21
00816537020943NovaBright14202-0012021-12-15
00816537020950NovaBright14213-0012021-12-15

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Primary DI, Brand, Company table
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