| Primary Device ID | B0046520081 |
| NIH Device Record Key | d1583c56-72d4-4036-8be2-665effea1de2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient-Fitted TMJ Reconstructive Prosthesis Syste |
| Version Model Number | 65-2008 |
| Company DUNS | 035877922 |
| Company Name | TMJ SOLUTIONS INC |
| Device Count | 5 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0046120081 [Unit of Use] |
| HIBCC | B0046520081 [Primary] |
| LZD | Joint, Temporomandibular, Implant |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
[B0046520081]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-27 |
| B004TYYNNNNRM0 | Right Mandibular Component |
| B004TYYNNNNRF0 | Right Fossa Component |
| B004TYYNNNNM0 | Anatomical Bone Model |
| B004TYYNNNNLM0 | Left Mandibular Component |
| B004TYYNNNNLF0 | Left Fossa Component |
| B0046523161 | Bone Screw 2.3mm x 16mm, 5 Pack |
| B0046523141 | Bone Screw 2.3mm x 14mm, 5 Pack |
| B0046523121 | Bone Screw 2.3mm x 12mm, 5 Pack |
| B0046523101 | Bone Screw 2.3mm x 10mm, 5 Pack |
| B0046523081 | Bone Screw 2.3mm x 8mm, 5 Pack |
| B0046523061 | Bone Screw 2.3mm x 6mm, 5 Pack |
| B0046520161 | Bone Screw 2.0mm x 16mm, 5 Pack |
| B0046520141 | Bone Screw 2.0mm x 14mm, 5 Pack |
| B0046520121 | Bone Screw 2.0mm x 12mm, 5 Pack |
| B0046520101 | Bone Screw 2.0mm x 10mm, 5 Pack |
| B0046520081 | Bone Screw 2.0mm x 8mm, 5 Pack |
| B0046520061 | Bone Screw 2.0mm x 6mm, 5 Pack |
| B0046520051 | Bone Screw 2.0mm x 5mm, 5 Pack |
| B0046123160 | Bone Screw 2.3mm x 16mm |
| B0046123140 | Bone Screw 2.3mm x 14mm |
| B0046123120 | Bone Screw 2.3mm x 12mm |
| B0046123100 | Bone Screw 2.3mm x 10mm |
| B0046123080 | Bone Screw 2.3mm x 8mm |
| B0046123060 | Bone Screw 2.3mm x 6mm |
| B0046120160 | Bone Screw 2.0mm x 16mm |
| B0046120140 | Bone Screw 2.0mm x 14mm |
| B0046120120 | Bone Screw 2.0mm x 12mm |
| B0046120100 | Bone Screw 2.0mm x 10mm |
| B0046120080 | Bone Screw 2.0mm x 8mm |
| B0046120060 | Bone Screw 2.0mm x 6mm |
| B0046120050 | Bone Screw 2.0mm x 5mm |
| B0046005200 | Sterilization Case Instrument Base |
| B0046005100 | Sterilization Case Screw Base |
| B0046005000 | Sterilization Case Lid |
| B0046004230 | Pilot Drill 2.3mm |
| B0046004200 | Pilot Drill 2.0mm |
| B0046003000 | Drill Guide |
| B0046002000 | Fossa Seating Tool |
| B0046001300 | Mandibular Forceps |
| B0046001200 | Implant Stabilizer |
| B0046001100 | Driver Blade |
| B0046001000 | Quick-Connect Instrument Handle |
| B0046000200 | TMJ Fixation Instrument Set (Loaner) |
| B0046000100 | TMJ Driver Handle and Blade (Loaner) |