K-number	K253248
Device name	Bright Cavity Liner
Applicant	Dmp Dental Industry S.A.
Product code	EJK
Device class	Class II
Decision date	Jan 13, 2026
Decision	Substantially Equivalent
Regulation	872.3250

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Bright Cavity Liner is a calcium hydroxide-based dental material used to line the floor and walls of tooth cavities prior to application of filling materials. It is intended for prescription use by dental professionals.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Bright Cavity Liner

Everything you need for a 510(k) submission. Nothing you don't.