| Primary Device ID | H66809210141 |
| NIH Device Record Key | e946f8bc-303e-485c-bc1d-2de883e66fbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bosworth SuperEBA |
| Version Model Number | 0921014 |
| Catalog Number | 0921014 |
| Company DUNS | 014769301 |
| Company Name | Harry J Bosworth Company |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
| Total Volume | 1 Fluid Ounce |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66809210141 [Primary] |
| EMA | CEMENT, DENTAL |
| 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 |
| H66809210141 | 1 oz ZOE Cement Liquid |
| H66809210131 | 2 oz ZOE Cement Pwd, Reg |
| H66809210121 | 2 oz ZOE Cement Pwd, Fast |
| H66809210101 | 6.5 ml ZOE Cement Liquid |
| H66809210091 | 15 g ZOE Cement Pwd, Reg |
| H66809210081 | 15 g ZOE Cement Pwd, Fast |
| H6680921007R1 | 15 g Pwd & 6.5 ml Liq Cement Kit, Reg Set |
| H6680921007F1 | 15 g Pwd & 6.5 ml Liq Cement Kit, Fast Set |
| H66809210071 | 15 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set |