Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
The Dental Cement Without Zinc Oxide Eugenol for Ulcer Covering and Pain Relief is a dental device used to place a temporary protective covering over oral ulcers or exposed dentinal surfaces to provide pain relief without the use of zinc oxide eugenol, which can cause irritation in some patients. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 872.3275 (Dental specialty). This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- MZW
- Device Class
- FDA class 2
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.