| Primary Device ID | D687AD330640 |
| NIH Device Record Key | 120627c7-60ea-48f5-9ef9-df6a987b1fe7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dentray II |
| Version Model Number | AD33057FG |
| Catalog Number | AD33064 |
| Company DUNS | 056296981 |
| Company Name | Sultan Healthcare Inc |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
|---|---|
| HIBCC | D687AD330640 [Unit of Use] |
| HIBCC | D687AD330641 [Primary] |
| EHY | TRAY, IMPRESSION, PREFORMED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-12 |
| Device Publish Date | 2022-12-03 |
| D687AD330640 | Dentray II #10S Lower Anterior Solid Package of 12 |
| D687AD33060FG0 | Dentray II #10P Lower Anterior Perforated Package of 12 |
| D687AD33059FG0 | Dentray II #9P Upper Anterior Perforated Package of 12 |
| D687AD33058FG0 | Dentray II #8P Upper Right Lower Left Perforated Package of 12 |
| D687AD33057FG0 | Dentray II #7P Upper Left Lower Right Perforated Package of 12 |
| D687AD33056FG0 | Dentray II #6P Small Lower Perforated Package of 12 |
| D687AD33055FG0 | Dentray II #5P Small Upper Perforated Package of 12 |
| D687AD33054FG0 | Dentray II #4P Medium Lower Perforated Package of 12 |
| D687AD33053FG0 | Dentray II #3 Medium Upper Perforated Package of 12 |
| D687AD33052FG0 | Dentray II #2P Large Lower Perforated Package of 12 |
| D687AD33051FG0 | Dentray II #1P Large Upper Perforated Package of 12 |
| D687AD330500 | Dentray II Impression Trays Assorted Package of 12 |