Cleared Traditional

K945378 - PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT

K945378 is an FDA 510(k) clearance for PULPDENT CHEMICAL CURE PIT AND FISSURE ..., manufactured by Pulpdent Corp.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K945378 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
76d
Days
Class 2
Risk

K945378 is an FDA 510(k) clearance for the PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 76 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 Pulpdent Corp. devices

FDA 510(k) Submission Details - K945378

510(k) Number K945378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date January 17, 1995
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 105
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K945378.
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701 · American Dental Products, Inc. · Oct 1995
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K952240 · Jeneric/Pentron, Inc. · Aug 1995
DELTON F PIT & FISSURE SEALANT
K951296 · Dentsply Intl. · May 1995
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · Pulpdent Corp. · Sep 1993
HELIOSEAL F
K932078 · Ivoclar North America, Inc. · Sep 1993
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
K931857 · Confi-Dental Products Co. · Jul 1993