| Primary Device ID | M595S2880 |
| NIH Device Record Key | 0cb27130-d287-4eb6-a1b0-65f02eb09528 |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Brush&Bond® |
| Version Model Number | S288 |
| Catalog Number | S288 |
| 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dark, cool, low humidity environment. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M595S2880 [Primary] |
| KLE | Agent, Tooth Bonding, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2016-09-23 |
| 00810000529155 | Brush&Bond® Kit with Mini/Endo B&B Activator Brushes |
| 00810000529124 | Brush&Bond® Dentin/Enamel Bonding Liquid 3ml. |
| 00810000529117 | Brush&Bond® Kit |
| 00810000529094 | Brush&Bond® Universal Liquid 3ml. |
| 00810000529087 | Brush&Bond® Universal Bonding System |
| M595S2880 | Brush&Bond® Kit with Mini/Endo B&B Activator Brushes |
| M595S2871 | Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.) |
| M595S2861 | Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.) |
| M595S2850 | Brush&Bond® Dentin/Enamel Bonding Liquid 3ml. |
| M595S2840 | Brush&Bond® Kit |
| M595S2420 | Brush&Bond® Universal Liquid 3ml. |
| M595S2400 | Brush&Bond® Universal Bonding System |
| 00810000529674 | Brush&Bond® MAX Bonding Liner |
| 00810000529667 | Brush&Bond® MAX Kit |
| 10810000529145 | Brush&Bond® Mini/Endo Activator Brushes (Pkg. of 100 pcs.) |
| 10810000529138 | Brush&Bond® Standard Activator Brushes (Pkg. of 100 pcs.) |