Cleared Traditional

K791318 - MIRADAPT* DENTAL RESTORATIVE

K791318 is an FDA 510(k) clearance for MIRADAPT* DENTAL RESTORATIVE, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K791318 · Johnson & Johnson Professionals, Inc. · Dental device
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Sep 1979
Decision
62d
Days
Class 2
Risk

K791318 is an FDA 510(k) clearance for the MIRADAPT* DENTAL RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 62 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K791318

510(k) Number K791318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date September 12, 1979
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
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 699
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K791318.
COMPOSITE RESTORATIVE, PASTE/TYPE
K792140 · Scientific Pharmaceuticals, Inc. · Nov 1979
SCI-PHARM POLIFIL ANTERIOR RESTORATIVE
K791602 · Scientific Pharmaceuticals, Inc. · Nov 1979
VISIO-DISPERS
K790823 · Espe GmbH (Us) · Oct 1979
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K790789 · Scientific Pharmaceuticals, Inc. · Jul 1979
ANTERIOR/POSTERIOR RESTORATIVE LIQUID
K790822 · Scientific Pharmaceuticals, Inc. · Jul 1979
PAINT-ON RESTORATIVE, LIGHT CURED
K790963 · Scientific Pharmaceuticals, Inc. · Jul 1979