| Primary Device ID | 00815967021728 |
| NIH Device Record Key | 32933b59-a4c3-4734-838b-0342e72d8d1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pac-Dent |
| Version Model Number | 8122 |
| Company DUNS | 959077454 |
| Company Name | PAC-DENT INTERNATIONAL 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815967021728 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| 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 | 2016-09-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PAC-DENT 88938193 not registered Live/Pending |
Pac-Dent, Inc. 2020-05-28 |