Prosthetic devices · 21 CFR 872 Subpart D
Arch Tracing Ink
FDA device type “Ink, Arch Tracing”.
- Companies listing it
- 32 makers
- Brands and models
- 4
- 510(k) clearances
- 20 in five years
- FDA name
- Ink, Arch Tracing
510(k) clearances per year, 1976–2026
Companies that list KZO
3 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Ivoclar Vivadent, AG | United States | Maker | Gnathometer- CAD · Gnathometer-M | 94 | 2026 |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 5 May 1981 | K810972 | THE GNATHOMETER-M | Bauer, Cheng & Associates, Inc. |
| 16 Aug 1977 | K771176 | GOTHIC ARCH TRACING | Dentsply Intl., Inc. |
Official records: FDA product classification for KZO · 21 CFR 872.3150.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026