Cleared Traditional

K954461 - AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE

K954461 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE, manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K954461 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
21d
Days
Class 2
Risk

K954461 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 21 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 American Dental Products, Inc. devices

FDA 510(k) Submission Details - K954461

510(k) Number K954461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date October 16, 1995
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
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 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K954461.
AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE
K954406 · American Dental Products, Inc. · Oct 1995
AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE
K954407 · American Dental Products, Inc. · Oct 1995
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE
K954408 · American Dental Products, Inc. · Oct 1995
ARTGLASS & KEVLOC
K954115 · Heraeus Kulzer, Inc. · Sep 1995
COMP=FLOW
K952662 · Jeneric/Pentron, Inc. · Aug 1995
ULTRADENT FLOWABLE COMPOSITE
K953525 · Ultradent Products, Inc. · Aug 1995