| Primary Device ID | D040711861 |
| NIH Device Record Key | 6237eb5f-bcb3-4317-8212-b2038c660929 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Keystone Keysplint Soft 1Kg |
| Version Model Number | 71186 |
| Company DUNS | 006385173 |
| Company Name | WHIP-MIX 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 | 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 |
|---|---|
| HIBCC | D040711861 [Primary] |
| KMY | Positioner, Tooth, 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 | 2021-09-06 |
| Device Publish Date | 2021-08-27 |
| D040200113770 - Denar Mark 310 Articulator | 2024-03-06 A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosi |
| D040200113780 - Denar Mark 320 Articulator | 2024-03-06 A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosi |
| D040200114080 - Denar Mark 330 Articulator | 2024-03-06 A dental articulator is a device designed to simulate all or part of the mandibular movements and used for examination, diagnosi |
| D04020000031 - Denar Deprogrammer | 2023-11-22 |
| D04020002950 - Unit-Assy Slidematic | 2023-11-06 A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the t |
| D04020011540 - Unit Assembly 9645 FB | 2023-11-06 A facebow is a device intended for use in a dental diagnostic procedure to record the relative position of the mandible to the |
| D040600081 - ARDENT | 2023-11-06 Ardent™ Articulating Paper Quadrant Red Blue Curved .0025 144 Strips 63 microns |
| D040600130 - ARDENT | 2023-11-06 Ardent™ Complete Kit- Trial Kit |