Cleared Traditional

K851053 - TUBULITEC LINER

K851053 is an FDA 510(k) clearance for TUBULITEC LINER, manufactured by Dental Therapeutics AB. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K851053 · Dental Therapeutics AB · Dental device
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Jul 1985
Decision
133d
Days
Class 2
Risk

K851053 is an FDA 510(k) clearance for the TUBULITEC LINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Dental Therapeutics AB (Nacka, SE). The FDA issued a Cleared decision on July 25, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dental Therapeutics AB devices

FDA 510(k) Submission Details - K851053

510(k) Number K851053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1985
Decision Date July 25, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 128d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 61
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K851053.
GLASS IONOMER BASE
K882751 · Dentsply Intl. · Nov 1988
ALKALINER
K873882 · Espe GmbH (Us) · Feb 1988
KERR CAVALITE
K872147 · Kerr Corporation (Danbury) · Aug 1987
KERR SEALAPEX ROOT CANAL SEALER
K841910 · Sybron Corp. · Jul 1984
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575 · Coe Laboratories, Inc. · Jun 1983
IMPROVED DYCAL
K820215 · Dentsply Intl. · Mar 1982