Cleared Traditional

K790585 - FINESSE

K790585 is an FDA 510(k) clearance for FINESSE, manufactured by L.D. Caulk Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K790585 · L.D. Caulk Co. · Dental device
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May 1979
Decision
50d
Days
Class 2
Risk

K790585 is an FDA 510(k) clearance for the FINESSE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1979 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K790585

510(k) Number K790585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date May 16, 1979
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 693
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K790585.
ANTERIOR/POSTERIOR RESTORATIVE LIQUID
K790822 · Scientific Pharmaceuticals, Inc. · Jul 1979
PAINT-ON RESTORATIVE, LIGHT CURED
K790963 · Scientific Pharmaceuticals, Inc. · Jul 1979
DENTAL COMPOSITE RESTORATIVE MATERIAL
K790594 · Wallace A. Erickson & Co. · Jun 1979
AUROFIL
K781687 · Wallace A. Erickson & Co. · Dec 1978
ZYTRON
K780796 · Premier Dental Products Co. · Jun 1978
NEW RESTODENT
K780965 · Lee Pharmaceuticals · Jun 1978