Fortress PFM Incisal 2

GUDID FMI211

Fortress PFM Porcelain Powder 28 gram

CHAMELEON DENTAL PRODUCTS, INC

Dental porcelain/ceramic restoration kit
Primary Device IDFMI211
NIH Device Record Key65c2dd3e-fc91-485b-b01f-0bbb72d1b9d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFortress PFM Incisal 2
Version Model NumberFMI2
Company DUNS174145664
Company NameCHAMELEON DENTAL PRODUCTS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCFMI211 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-08
Device Publish Date2018-09-06

Devices Manufactured by CHAMELEON DENTAL PRODUCTS, INC

MPOK11 - Mirage Prime One Kit2024-02-16 Dentine Bonding Kit
MPOKR1 - Mirage Prime One Dentin Enamel Primer2024-02-16 6 ml Dentin Enamel Primer
MUFRBNHCR1 - Mirage Ceramic Bonding Resin2019-07-22 Dental Ceramic Bonding Resin
ABCRC1 - Mirage Dentin Metal Adhesive Activator2019-04-23 Dentin Adhesive Metal Activator
FPA128 - FORTRESS PORCELAIN A1 28 GRAM2019-03-11 DENTAL PORCELAIN POWDER FOR CREATING DENTAL RESTORATIONS
ABCRA1 - MIRAGE RESIN ADHESIVE ACTIVATOR 2019-03-11 DENTIN ADHESIVE RESIN ACTIVATOR
ABCRN1 - Mirage Nitric Acid conditioner2018-11-19 Dental Etching liquid
DPKI11 - Mirage Diamond Paste2018-10-18 PorcelainPolishing Paste

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