FDA.reportPublic FDA data

FORTRESS PORCELAIN A1 28 GRAM

Primary DI
FPA128
Brand
FORTRESS PORCELAIN A1 28 GRAM
Company
CHAMELEON DENTAL PRODUCTS, INC
Model
FPA128
Device description
DENTAL PORCELAIN POWDER FOR CREATING DENTAL RESTORATIONS
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
FPA128PrimaryHIBCC0

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
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
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