DenteShield™ Orthodontic Primer, 3ml

Primary DI: 00851951008085
Brand: DenteShield™ Orthodontic Primer, 3ml
Company: SELENBIO DENTAL, INC.
Model: SBD-200-5
Published: 2018-04-11
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: false
OTC: false
Sterile: false
Single use: false

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00851951008085	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00851951008085	00851951008085	851951008085	0851951008085

GMDN Terms#

Term, Definition table
Term	Definition
Dental composite resin kit	A 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
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: false
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00851951008115	DenteShield™ Pit & Fissure Sealant PLUS	SBD-650-3		2019-08-07
00851951008122	GingiShield™ Antibacterial Dental Sealant - Refill	SBD-950-5		2019-08-07
00851951008139	GingiShield™ Antibacterial Dental Sealant - Starter Kit	SBD-950-1		2019-08-07
00851951008054	DenteShield™ Pit & Fissure Sealant, Clear	SBD-600-1		2018-04-11
00851951008061	DenteShield™ Pit & Fissure Sealant, Opaque	SBD-600-5		2018-04-11
00851951008078	DenteShield™ Orthodontic Primer, 7ml	SBD-200-1		2018-04-11
00851951008092	DenteShield™ Light Cure Ortho Enamel Surface Sealant, 3ml	SBD-100-5		2018-04-11
00851951008108	DenteShield™ Light Cure Ortho Enamel Surface Sealant, 7ml	SBD-100-1		2018-04-11