| Primary Device ID | M595S3950 |
| NIH Device Record Key | 40082a08-7ab5-4dc1-bbfa-3d80c3cfed4a |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | C&B METABOND® |
| Version Model Number | S395 |
| Catalog Number | S395 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| 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 |
| Phone | 6312491134 |
| customerservice@parkell.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry location. Avoid exposure to heat and light. Do not refrigerate catalyst. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M595S3950 [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 | 2019-04-01 |
| Device Publish Date | 2016-09-23 |
| 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 |