| Primary Device ID | D810PCSD2098NS111 |
| NIH Device Record Key | 7d8f2b26-69aa-4b7a-96fc-eab21e697d81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Original Clearsplint Disc |
| Version Model Number | PCSD98N |
| Catalog Number | PCSD98N |
| Company DUNS | 056624901 |
| Company Name | ASTRON DENTAL 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 | false |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 847-726-8787 |
| doug@astrondental.com | |
| Phone | 847-726-8787 |
| doug@astrondental.com | |
| Phone | 847-726-8787 |
| doug@astrondental.com | |
| Phone | 847-726-8787 |
| doug@astrondental.com | |
| Phone | 847-726-8787 |
| doug@astrondental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D810PCSD2098NS111 [Primary] |
| MQC | Mouthguard, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-26 |
| Device Publish Date | 2021-07-16 |
| D810PCSD985111 | Package of 1 disc 98mmX20mm with shoulder |
| D810PCSD2098NS111 | Package of 1 disc 98mmX20mm with no shoulder |
| D810PCSD2095Z111 | Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge |
| D810PCSD1698111 | Package of 1 disc 98mmX16mm with shoulder |