Cleared Traditional

K954701 - AMERICAN DENTAL PRODUCTS PIT & FISSUE S...

K954701 is an FDA 510(k) clearance for AMERICAN DENTAL PRODUCTS PIT & FISSUE S..., manufactured by American Dental Products, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K954701 · American Dental Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
18d
Days
Class 2
Risk

K954701 is an FDA 510(k) clearance for the AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by American Dental Products, Inc. (Medinah, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 - K954701

510(k) Number K954701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date October 30, 1995
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 85
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K954701.
PULPDENT SEAL-RITE UDMA
K963921 · Pulpdent Corp. · Nov 1996
GLY-ETCH
K961190 · Centrix, Inc. · Apr 1996
SEALITE FL
K954827 · Sybron Dental Specialties, Inc. · Jan 1996
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K952240 · Jeneric/Pentron, Inc. · Aug 1995
DELTON F PIT & FISSURE SEALANT
K951296 · Dentsply Intl. · May 1995
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K945378 · Pulpdent Corp. · Jan 1995