Cleared Traditional

K791078 - ANTERIOR/POSTERIOR RESTORATIVE, BOND

K791078 is an FDA 510(k) clearance for ANTERIOR/POSTERIOR RESTORATIVE, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K791078 · Scientific Pharmaceuticals, Inc. · Dental device
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Aug 1979
Decision
59d
Days
Class 2
Risk

K791078 is an FDA 510(k) clearance for the ANTERIOR/POSTERIOR RESTORATIVE, BOND. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Scientific Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K791078

510(k) Number K791078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date August 10, 1979
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 45
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K791078.
CONCLUDE COMPOSITE LUTING CEMENT
K822714 · 3M Company · Sep 1982
MYERSON/KENSON GP POLYMER
K813328 · Howmedica Corp. · Feb 1982
SCI-PHARM PAINT-ON RESTORATIVE
K791067 · Scientific Pharmaceuticals, Inc. · Aug 1979
COLORANT
K790438 · Vivadent (Usa), Inc. · Apr 1979
ADHESION PROMOTOR
K760419 · Lee Pharmaceuticals · Aug 1976