| Primary Device ID | 20818524020145 |
| NIH Device Record Key | 9bbddfcc-f0ed-48e3-91f4-f2ac9897e732 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROOT LABS - BITE REGISTRATION |
| Version Model Number | RL800 |
| Catalog Number | RL800 |
| Company DUNS | 030479000 |
| Company Name | CROWN DELTA CORPORATION |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818524020141 [Primary] |
| GS1 | 10818524020148 [Package] Contains: 00818524020141 Package: KIT [4 Units] In Commercial Distribution |
| GS1 | 20818524020145 [Package] Contains: 10818524020148 Package: CASE [10 Units] In Commercial Distribution |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-05-01 |
| 00818524020714 - EVOLVE KoR | 2023-09-29 EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE |
| 00818524020707 - IMPRESS-RITE HP-MIXING TIPS | 2020-12-30 M&S DENTAL IMPRESS-RITE HP TEMPORARY CEMENT MIXING TIP |
| 00818524020684 - IMPRESS-RITE T-MIXING TIPS | 2020-12-22 M&S DENTAL CORE MATERIAL T-MIXER BROWN 1:1 BLUNT END 20 PER BAG |
| 00818524020646 - IMPRESS-RITE 380 | 2020-02-24 M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT |
| 10818524020629 - IMPRESS-RITE | 2020-02-18 M&S DENTAL IMPRESS-RITE 380 HEAVY BODY REGULAR SET |
| 10818524020605 - IMPRESS-RITE T-MIXING TIPS | 2020-02-12 M&S DENTAL IMPRESS-RITE T-MIXERS C&B BLUE ORANGE 25 PER BAG |
| 00818524020523 - IMPRESS-RITE HP MIXING TIPS | 2020-02-06 M&S DENTAL IMPRESS-RITE C&B BLUE ORANGE 25 PER BAG |
| 10818524020377 - IMPRESS-RITE T-MIXING TIPS | 2019-11-06 M&S DENTAL IMPRESS-RITE GREEN T-MIXERS (6.5MM) 48/BAG |