FDA.reportPublic FDA data

Mirage Prolong Bond Enhancer Kit

Primary DI
MPBEK1
Brand
Mirage Prolong Bond Enhancer Kit
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
PBEK
Device description
dental Silane Bond Enhancer kit to enhance bond of restoration to tooth structure
Published
2018-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
MPBEK1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis priming agentA material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
174145664
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
ABCRN1Mirage Nitric Acid conditionerABCRN2018-10-19
MUFRTR1Mirage Tooth Bonding ResinUFR2019-07-12
MPOK11Mirage Prime One KitPOK2018-10-19
MPOKR1Mirage Prime One Dentin Enamel PrimerPOKR2019-04-19
MUFRBNHCR1Mirage Ceramic Bonding ResinUFRBNH2019-07-12
ABCRC1Mirage Dentin Metal Adhesive ActivatorABCRC2019-04-15
ABCRA1MIRAGE RESIN ADHESIVE ACTIVATOR ABCRA2019-02-21
ABCRB1MIRAGE ADHESIVE RESIN BABCRBABCRB2018-08-28
MSBE11Mirage Silane Bond EnhancerSBE2020-01-20
MDP847Mirage Diamond Paste-847 grams DP8472019-04-25
MEVKSM1MIRAGE ENVISION STARTER BONDING KIT-MODIFIEDEVKSM2019-02-21
MPBERA1Mirage Prolong Silane Bond Enhancer APBERA2019-02-21
MPBERB1MIRAGE PROLONG SILANE BOND ENHANCER BPBERB2019-02-21
FPA128FORTRESS PORCELAIN A1 28 GRAMFPA1282019-02-21
MEVK11Envision Complete Bonding SystemEVK2018-11-08
MEVKM1 Envision Complete Bonding System (modified)EVKM2018-11-08
DPKI11Mirage Diamond PasteDPKIDPKI2018-09-17
FMI211Fortress PFM Incisal 2FMI22018-09-06
EVRDCU1MIRAGE ENVISION DUAL CURE UNIVERSALEVRDCUEVRDCU2018-08-29