FDA.reportPublic FDA data

Fortress PFM Incisal 2

Primary DI
FMI211
Brand
Fortress PFM Incisal 2
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
FMI2
Device description
Fortress PFM Porcelain Powder 28 gram
Published
2018-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
FMI211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
174145664
Device count
1
Kit
true
Lot or batch
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
MPBEK1Mirage Prolong Bond Enhancer KitPBEK2018-10-26
DPKI11Mirage Diamond PasteDPKIDPKI2018-09-17
EVRDCU1MIRAGE ENVISION DUAL CURE UNIVERSALEVRDCUEVRDCU2018-08-29