Cleared Traditional

K831077 - DENTALON

K831077 is the FDA 510(k) clearance for DENTALON by Kulzer, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K831077 · Kulzer, Inc. · Dental device
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Sep 1983
Decision
161d
Days
Class 2
Risk

K831077 is an FDA 510(k) clearance for the DENTALON. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Kulzer, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Kulzer, Inc. devices

Submission Details

510(k) Number K831077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date September 12, 1983
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 101
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K831077.
CAVIT-W
K875133 · Espe GmbH (Us) · Mar 1988
MAR BOND
K875145 · Reliance Orthodontic Products, Inc. · Feb 1988
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
PROTEMP
K822452 · Espe GmbH (Us) · Sep 1982
TEMP. CROWN MSTERIAL FOR TEETH
K781244 · Den-Mat Corp. · Aug 1978
MYERSONS SPEC. CROWN & BRIDGE RESIN
K771602 · Howmedica Corp. · Aug 1977