| Primary Device ID | J014660009051 |
| NIH Device Record Key | ff2dd466-7077-42a9-bf74-188fac7510aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BITE REG INTRAORAL TIP CD 96 |
| Version Model Number | 66000905 |
| Catalog Number | 66000905 |
| Company DUNS | 315666321 |
| Company Name | Heraeus Kulzer GmbH |
| Device Count | 96 |
| DM Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014660009050 [Primary] |
| HIBCC | J014660009051 [Unit of Use] |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-17 |
| Device Publish Date | 2024-09-09 |
| J014500354060 - PROVIL NOVO L. 1X280 ML | 2024-09-17 Material, Impression |
| J014500354120 - PROVIL NOVO P SOFT FAST 1X500 | 2024-09-17 Material, Impression |
| J014656875141 - IOT white 96 | 2024-09-17 Syringe, Restorative and Impression Material |
| J014657670380 - CUTTERSIL P PLUS 1X900 ML | 2024-09-17 Material, Impression |
| J014658179300 - CUTTERSIL LIGHT GREEN 1X140 ML | 2024-09-17 Material, Impression |
| J014660007810 - Dispensing Gun 4:1 | 2024-09-17 Instruments, Dental Hand |
| J014660007821 - IOT yellow 96 | 2024-09-17 Syringe, Restorative and Impression Material |
| J014660009051 - BITE REG INTRAORAL TIP CD 96 | 2024-09-17Syringe, Restorative and Impression Material |
| J014660009051 - BITE REG INTRAORAL TIP CD 96 | 2024-09-17 Syringe, Restorative and Impression Material |