Cleared Traditional

K771404 - NUVA-FIL COMPOSITE RESTORATIVE (MODI.)

K771404 is an FDA 510(k) clearance for NUVA-FIL COMPOSITE RESTORATIVE (MODI.), 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 5-day FDA review.

K771404 · L.D. Caulk Co. · Dental device
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Aug 1977
Decision
5d
Days
Class 2
Risk

K771404 is an FDA 510(k) clearance for the NUVA-FIL COMPOSITE RESTORATIVE (MODI.). 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 August 3, 1977 after a review of 5 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 - K771404

510(k) Number K771404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1977
Decision Date August 03, 1977
Days to Decision 5 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
122d faster than avg
Panel avg: 127d · This submission: 5d
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 698
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K771404.
ESTIC MICROFILL
K780833 · Degussa Dental, Inc. · Jun 1978
FOTOFILL DENTAL RESTORATIVE
K772279 · Johnson & Johnson Professionals, Inc. · Jan 1978
NIMETICAP
K771654 · Espe GmbH (Us) · Sep 1977
DENTAL RESTORATIVE IN CAPSULES
K770922 · Espe GmbH (Us) · Jun 1977
ENAMELITE ENAMEL COATING
K770109 · Lee Pharmaceuticals · Jan 1977
COMPOSITE RESTORATIVE MATERIAL, PRESTIGE
K770055 · Lee Pharmaceuticals · Jan 1977