FDA.reportPublic FDA data

Envision Complete Bonding System (modified)

Primary DI
MEVKM1
Brand
Envision Complete Bonding System (modified)
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
EVKM
Device description
Dental Bonding Kit
Published
2018-11-08
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
MEVKM1PrimaryHIBCC0

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
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
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