| Primary Device ID | 00810000529643 |
| NIH Device Record Key | 04f85067-79b5-4fd1-9fab-d9760590dcfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C&B METABOND® |
| Version Model Number | S378 |
| Catalog Number | S378 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 3 |
| 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 | false |
| 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 | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000529643 [Unit of Use] |
| GS1 | 10810000529640 [Primary] |
| EMA | Cement, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-22 |
| Device Publish Date | 2023-12-14 |
| 00810000529230 | L-Powder Clear 3 grams for C&B METABOND® |
| 00810000529223 | ‘B’ Quick Base 10ml. for C&B METABOND® |
| 00810000529216 | L-Radiopaque Tooth Shade Powder 5grams for C&B METABOND® |
| 00810000529209 | Enamel Etchant Gel (Red) 5ml. for C&B METABOND® |
| 00810000529193 | ‘A’ Liquid Universal Dentin Activator 6ml. for C&B METABOND® & AMALGAMBOND® |
| 00810000529162 | C&B METABOND® Adhesive Cement System |
| 00810000529070 | ‘A’ Gel Universal Dentin Activator 5ml. for C&B METABOND® & AMALGAMBOND® |
| M595S3950 | Enamel Etchant Gel (Red) 5ml. for C&B METABOND® |
| 00810000529186 | Ceramic Mixing Dish for C&B MetaBond® |
| 00810000529643 | Measuring Scoops for C&B MetaBond® Powder |