GingiShield™ Antibacterial Dental Sealant - Starter Kit

Primary DI
00851951008139
Brand
GingiShield™ Antibacterial Dental Sealant - Starter Kit
Company
SELENBIO DENTAL, INC.
Model
SBD-950-1
Published
2019-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851951008139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851951008139008519510081398519510081390851951008139

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resin kitA collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080965107
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851951008115DenteShield™ Pit & Fissure Sealant PLUSSBD-650-32019-08-07
00851951008122GingiShield™ Antibacterial Dental Sealant - RefillSBD-950-52019-08-07
00851951008054DenteShield™ Pit & Fissure Sealant, ClearSBD-600-12018-04-11
00851951008061DenteShield™ Pit & Fissure Sealant, OpaqueSBD-600-52018-04-11
00851951008078DenteShield™ Orthodontic Primer, 7mlSBD-200-12018-04-11
00851951008085DenteShield™ Orthodontic Primer, 3mlSBD-200-52018-04-11
00851951008092DenteShield™ Light Cure Ortho Enamel Surface Sealant, 3mlSBD-100-52018-04-11
00851951008108DenteShield™ Light Cure Ortho Enamel Surface Sealant, 7mlSBD-100-12018-04-11