| Primary Device ID | H6681009227 |
| NIH Device Record Key | c220185f-5aa9-4f6f-8a0d-afa4b7c87bf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clearmet |
| Version Model Number | 1009227 |
| Catalog Number | 1009227 |
| Company DUNS | 073503117 |
| Company Name | Keystone Industries |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Length | 77 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H6681009227 [Primary] |
| HIBCC | H66810092270 [Unit of Use] |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-15 |
| H66810092291 | Clearmet Dental Appliance Extrusion Pellets, bulk bag |
| H6681009227 | Medium Dental Device Extrusion Pellets |
| H6681009225 | Small Dental Device Extrusion Pellets |