K253248

Bright Cavity Liner

510(k) number
K253248
Device name
Bright Cavity Liner
Applicant
Dmp Dental Industry S.A. GR
Product code
EJK — Liner, Cavity, Calcium Hydroxide
Decision date
2026-01-13
Date received
2025-09-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.