Prosthetic devices · 21 CFR 872 Subpart D
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief
FDA device type “Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief”.
- Companies listing it
- 81 makers
- Brands and models
- 5
- 510(k) clearances
- 20 in five years
- FDA name
- Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
510(k) clearances per year, 1976–2026
Companies that list MZW
8 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | Maxcem Elite | 203 | 2026 |
| Jersey Dental Supplies | United States | Repacker / relabeler | — | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Maxcem | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Maxcem | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Maxcem | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | MAXCEM 2 | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Jan 2008 | K073209 | MAXCEM 2 | Sybron Dental Specialties |
| 2 Sep 1999 | K991923 | SOOTHE-N-SEAL CANKER SORE RELIEF | Closure Medical Corp. |
Official records: FDA product classification for MZW · 21 CFR 872.3275.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026