| Primary Device ID | D04020011540 |
| NIH Device Record Key | a9575ac6-b302-4b41-ad7d-44a6c656f9ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unit Assembly 9645 FB |
| Version Model Number | 20011540 |
| Company DUNS | 006385173 |
| Company Name | WHIP-MIX CORPORATION |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | D04020011540 [Primary] |
| KCR | Facebow |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-06 |
| Device Publish Date | 2023-10-27 |
| D040711810 - VeriTray | 2024-04-30 VeriTray Turquoise - Impression Tray |
| D040711820 - Veri DENT Tryin | 2024-04-26 |
| 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 temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This is a reusable device. |
| 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 |