| Primary Device ID | 04064896000113 |
| NIH Device Record Key | a2df1568-4223-4a15-be78-29255aff1201 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monolith Prophy Paste MEDIUM "Spearmint" Cup |
| Version Model Number | M504 |
| Company DUNS | 117569946 |
| Company Name | PRISMAN INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04064896000113 [Primary] |
| EJR | Agent, Polishing, Abrasive, Oral Cavity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-10 |
| 04064896000564 - PWR Classic Powder Mint | 2024-11-01 Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel. |
| 04064896000571 - PWR Classic Powder Neutral | 2024-11-01 Sodium bicarbonate prophylaxis powder (40µ) for the supragingival removal of intractable plaque and discolorations on enamel. |
| 04064896000601 - PWR Perio Powder Mint | 2024-11-01 Prophylaxis powder based on non-cariogenic glycine (approx. 25µ). For the gentle, abrasive removal of supra- and subgingival pl |
| 04064896000625 - PWR Perio Powder Neutral | 2024-11-01 Prophylaxis powder based on non-cariogenic glycine (approx. 25µ). For the gentle, abrasive removal of supra- and subgingival pl |
| 04064896000014 - Air Supra | 2024-08-05 Prophylaxis powder based on non-cariogenic spherical calciumcarbonate (45µ). For the effective removal of supragingivial plaque |
| 04064896000038 - Air Supreme | 2024-08-05 Prophylaxis powder based on non-cariogenic tagatose (15µ). For the gentle abrasive removal of supra- and subgingival plaque and |
| 04064896000267 - Monolith InstruZyme conc. | 2022-01-17 |
| 04064896000427 - Monolith InstruZyme Powder conc. | 2022-01-17 |