Cleared Traditional

K780965 - NEW RESTODENT

K780965 is the FDA 510(k) clearance for NEW RESTODENT by Lee Pharmaceuticals. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K780965 · Lee Pharmaceuticals · Dental device
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Jun 1978
Decision
10d
Days
Class 2
Risk

K780965 is an FDA 510(k) clearance for the NEW RESTODENT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 10 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 Lee Pharmaceuticals devices

Submission Details

510(k) Number K780965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date June 22, 1978
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 593
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K780965.
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
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