Cleared Traditional

K791160 - DENTALEEN

K791160 is an FDA 510(k) clearance for DENTALEEN, manufactured by Denpac Corp.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K791160 · Denpac Corp. · Dental device
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Feb 1980
Decision
244d
Days
Class 2
Risk

K791160 is an FDA 510(k) clearance for the DENTALEEN. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Denpac Corp. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1980 after a review of 244 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Denpac Corp. devices

FDA 510(k) Submission Details - K791160

510(k) Number K791160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1979
Decision Date February 21, 1980
Days to Decision 244 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 128d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 437
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K791160.
SILICAP
K801227 · Vivadent (Usa), Inc. · Aug 1980
BONDALCAP (SILICO-PHOSPHATE)
K801228 · Vivadent (Usa), Inc. · Jun 1980
BONDALCAP (CARBOXYLATE)
K801229 · Vivadent (Usa), Inc. · Jun 1980
PROVIT
K800060 · Parker Laboratories, Inc. · Jan 1980
DENTAL CEMENT, ZINC PHOSPHATE
K790593 · Wallace A. Erickson & Co. · Jun 1979
CHEMBOND
K790586 · L.D. Caulk Co. · May 1979