FDA.reportPublic FDA data

MIRAGE ENVISION STARTER BONDING KIT-MODIFIED

Primary DI
MEVKSM1
Brand
MIRAGE ENVISION STARTER BONDING KIT-MODIFIED
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
EVKSM
Device description
DENTAL COMPOSITE BONDING KIT
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
MEVKSM1PrimaryHIBCC0

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.

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
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
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