| Primary Device ID | FMI211 |
| NIH Device Record Key | 65c2dd3e-fc91-485b-b01f-0bbb72d1b9d8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortress PFM Incisal 2 |
| Version Model Number | FMI2 |
| Company DUNS | 174145664 |
| Company Name | CHAMELEON DENTAL PRODUCTS, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | FMI211 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2018-09-06 |
| MPOK11 - Mirage Prime One Kit | 2024-02-16 Dentine Bonding Kit |
| MPOKR1 - Mirage Prime One Dentin Enamel Primer | 2024-02-16 6 ml Dentin Enamel Primer |
| MUFRBNHCR1 - Mirage Ceramic Bonding Resin | 2019-07-22 Dental Ceramic Bonding Resin |
| ABCRC1 - Mirage Dentin Metal Adhesive Activator | 2019-04-23 Dentin Adhesive Metal Activator |
| FPA128 - FORTRESS PORCELAIN A1 28 GRAM | 2019-03-11 DENTAL PORCELAIN POWDER FOR CREATING DENTAL RESTORATIONS |
| ABCRA1 - MIRAGE RESIN ADHESIVE ACTIVATOR | 2019-03-11 DENTIN ADHESIVE RESIN ACTIVATOR |
| ABCRN1 - Mirage Nitric Acid conditioner | 2018-11-19 Dental Etching liquid |
| DPKI11 - Mirage Diamond Paste | 2018-10-18 PorcelainPolishing Paste |