Surgical devices · 21 CFR 872 Subpart E
Parallelometer
FDA device type “Parallelometer”.
- Companies listing it
- 43 makers
- Brands and models
- 4
- 510(k) clearances
- 10 in five years
- FDA name
- Parallelometer
510(k) clearances per year, 1976–2026
Companies that list EGI
4 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Drill Guide | 1 | 2026 |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | Surveyor B2 Dental Surveyor / Parallelometer for dental prosthetic laboratory applications | — | — |
| Jiangsu Sintang Health&Technology Co.,Ltd | China | Maker | Parallel Bars | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Surveyor / Parallelometer | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 13 Aug 1980 | K801853 | PARALLEL-A-PREP | C.D. Charles, Inc. |
Official records: FDA product classification for EGI · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026