Miscellaneous devices · 21 CFR 872 Subpart G
Disk Guard
FDA device type “Guard, Disk”.
- Companies listing it
- 1310 makers
- Brands and models
- 14
- 510(k) clearances
- 10 in five years
- FDA name
- Guard, Disk
510(k) clearances per year, 1976–2026
Companies that list EEJ
13 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Directa AB | Sweden | Maker | Snap-on Discguard | 1 | 2015 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Face former · Oral Screen "Ulmer Model" · OrthoSafe | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Disk Guard | — | — |
| Lohar Medical Company | Pakistan | Maker | EEJ / GUARD, DISK | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Disk Guard | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | China | Maker | dental night guard | — | — |
| Ascend Excellence Daily Products Jiangsu Co., Ltd | China | Maker | Ascend · Dental Guard | — | — |
| DSD Planning Center SL | Spain | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Disc Guard | 23 | 2025 |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | PROTECTER DISC GUARD | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | DISK GUARD | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 12 Mar 1986 | K854467 | S.T.P.B SOFT TISSUES PROTECTIVES BLADES | Nortex USA, Inc. |
Official records: FDA product classification for EEJ · 21 CFR 872.6010.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026