Cleared Traditional

K942393 - TUBLI-SEAL EWT

K942393 is the FDA 510(k) clearance for TUBLI-SEAL EWT by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K942393 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
22d
Days
Class 2
Risk

K942393 is an FDA 510(k) clearance for the TUBLI-SEAL EWT. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K942393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1994
Decision Date June 10, 1994
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 73
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K942393.
AH PLUS ROOT CANAL SEALER
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CANAL KING (THIN) CANAL KING (THICK)
K940368 · Pulpdent Corp. · Jan 1995
PULPDENT ROOT CANAL SEALER
K946138 · Pulpdent Corp. · Jan 1995
PULPDENT EDTA PREPARATIONS
K932791 · Pulpdent Corp. · Sep 1993
ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
K896656 · Pulpdent Corp. · Feb 1990
ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
K896657 · Pulpdent Corp. · Feb 1990