FDA.reportPublic FDA data

NovaBright

Primary DI
30816537020944
Brand
NovaBright
Company
NANOVA BIO MATERIALS INC
Model
14202-002
Device description
0.4mL Sodium Fluoride White Varnish (Bubblegum) - 2 Units
Published
2020-05-22
Public version status
New
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
LBHVARNISH, CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30816537020944PrimaryGS10
00816537020943Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081653702094430816537020944
00816537020943008165370209438165370209430816537020943

GMDN Terms#

Term, Definition table
TermDefinition
Fluoride gelA preparation in the form of a gel, containing fluorine, in a chemical form and sufficient concentration to permit the treatment of tooth tissues by topical application. 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
2
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816537023012FiberFIX160129-1160129-12026-06-09
00816537023029FiberFIX160135-1160135-12026-06-09
00816537023036FiberFIX160145-1160145-12026-06-09
00816537023043FiberFIX190145-1190145-12026-06-09
00816537023050FiberFIX190155-1190155-12026-06-09
00816537023067FiberFIX190165-1190165-12026-06-09
00816537023234FiberFIX160125-1160125-12026-06-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850006606740Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606757Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606788Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606795Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606825Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606832Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606863Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606870Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606900Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606917Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606948Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606955Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00850006606986Wonderful DentalRoses and Rubies, LLCLBH2026-08-27
00197998150340Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150371Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150401Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150432Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150463Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150494Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998150517Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219092Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219108Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219115Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219139Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219146Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998219214Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
00197998486050Solventum™ Clinpro™Solventum US LLCLBH2026-08-23
E22122751VOCO Profluorid Varnish + BioMinVOCO GmbHLBH2026-07-26
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10