Cleared Traditional

K780384 - IMPROVED DYCAL

K780384 is an FDA 510(k) clearance for IMPROVED DYCAL, manufactured by L.D. Caulk Co.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K780384 · L.D. Caulk Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1978
Decision
6d
Days
Class 2
Risk

K780384 is an FDA 510(k) clearance for the IMPROVED DYCAL. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1978 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all L.D. Caulk Co. devices

FDA 510(k) Submission Details - K780384

510(k) Number K780384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1978
Decision Date March 15, 1978
Days to Decision 6 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 127d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.