Diagnostic devices · 21 CFR 872 Subpart B
Jaw Tracking Device for Monitoring Jaw Positions
FDA device type “Device, Jaw Tracking, For Monitoring Jaw Positions”.
- Companies listing it
- 158 makers
- Brands and models
- 47
- 510(k) clearances
- 20 in five years
- FDA name
- Device, Jaw Tracking, For Monitoring Jaw Positions
510(k) clearances per year, 1976–2026
Companies that list NFS
15 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Bioresearch | United States | Maker | BioPAK · JT-3 | 2 | 1995 |
| Endo Tech Instruments | Pakistan | Maker | ALLIGATOR SERR JAW STD PTRN 10MM SATIN · ALLIGATOR SERR JAW,8MM SATIN,DELICATE · ALLIGATOR SMOOTH,DEL 4MM JAW,3-1/2in · Atraumatic Angled (6mm) Jaws, 9? (229mm) · +6 | — | — |
| Shining 3D Tech Co., Ltd. | China | Maker | MetiSmile, MetiSmile-MR | — | — |
| ModJaw SAS | France | Maker | Fiducials (x36) · Forks (x20) · Frontal tracker (x1) · Kit patient · +7 | — | — |
| zebris Medical GmbH | Germany | Maker | Accessories: Alignment Spoon; Paraocclusal Attachment; Paraocclusal Attachment with Lip Arch; · Accessories: Occlusal Attachment UN; Bite Fork UN; Bite Fork Adapter UN; Bite Fork PS1; Fusion Bite; Fusion Bite Adapter · JMA-Optic · JMA-Optic AG "zebris for ceramill" · +3 | — | — |
| Myotronics-Noromed, Inc | United States | Maker | ESG-1 ELECTROSONOGRAM | — | — |
| Morpheus Co., Ltd. | South Korea | Maker | FACECAST DENTAL | — | — |
| Gamma Medizinisch Wissenschaftliche Fortbildungsge | Austria | Maker | — | — | — |
| GC America Inc. | United States | Contract manufacturer | Dental Prescale II | 137 | 2026 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| KaVo Dental GmbH | Germany | Contract manufacturer | 105.2301 - ARCUS digma USB | 2 | 2021 |
| Schutz Dental GmbH | Germany | Foreign exporter | Alignment Spoon (Alignment Fork) · Bite Fork Adapter UN · Bite Fork UN · JMA Optic · +1 | 7 | 2016 |
| Sicat GmbH & Co. KG | Germany | Foreign exporter | Fusion Bite · Fusion Bite Adapter · Paraocclusal Attachment | 1 | 2016 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| Bioesthetic Technologies | United States | Repacker / relabeler | Accessories: Alignment Spoon; Paraocclusal Attachment; Paraocclusal Attachment with Lip Arch · Accessories: Occlusal Attachment UN; Bite Fork UN; Bite Fork Adapter UN; Bite Fork PS1 · JMA-Optic | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 21 Sep 1995 | K952218 | JT-3 ELECTROGNATHOGRAPH | Bioresearch |
| 14 Nov 1984 | K843951 | SIROGNATHOGRAPH | Siemens Medical Solutions USA, Inc. |
Official records: FDA product classification for NFS · 21 CFR 872.2060.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026