FDA.reportPublic FDA data

Mirage Prolong Silane Bond Enhancer A

Primary DI
MPBERA1
Brand
Mirage Prolong Silane Bond Enhancer A
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
PBERA
Device description
SILANE BOND ENHANCER USED TO ENHANCE BOND ON TOOTH RESTORATION
Published
2019-02-21
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
MPBERA1PrimaryHIBCC0

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
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
MPBEK1Mirage Prolong Bond Enhancer KitPBEK2018-10-26
DPKI11Mirage Diamond PasteDPKIDPKI2018-09-17
FMI211Fortress PFM Incisal 2FMI22018-09-06
EVRDCU1MIRAGE ENVISION DUAL CURE UNIVERSALEVRDCUEVRDCU2018-08-29