Cleared Traditional

K801690 - VALIANT

K801690 is an FDA 510(k) clearance for VALIANT, manufactured by L.D. Caulk Co.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K801690 · L.D. Caulk Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
21d
Days
Class 2
Risk

K801690 is an FDA 510(k) clearance for the VALIANT. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 - K801690

510(k) Number K801690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1980
Decision Date August 13, 1980
Days to Decision 21 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
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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.

Regulatory Peers - EJJ Alloy, Amalgam

All 36
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K801690.
SYBRON/KERR CONTOUR
K820181 · Sybron Corp. · Feb 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
PERMITE DENTAL AMALGAM ALLOY
K801639 · Southern Dental Industries, Inc. · Aug 1980
ALLOY, AMALGAM, DISP. CAPSULE
K781242 · Lee Pharmaceuticals · Aug 1978
LEE-ALLOY
K780967 · Lee Pharmaceuticals · Jun 1978
EASE (MODIFICATION TO)
K771403 · L.D. Caulk Co. · Aug 1977