Cleared Traditional

K791088 - MONOJECT PULP-CAPPING MATERIAL

K791088 is an FDA 510(k) clearance for MONOJECT PULP-CAPPING MATERIAL, manufactured by Sherwood Medical Co.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K791088 · Sherwood Medical Co. · Dental device
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Oct 1979
Decision
132d
Days
Class 2
Risk

K791088 is an FDA 510(k) clearance for the MONOJECT PULP-CAPPING MATERIAL. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 22, 1979 after a review of 132 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K791088

510(k) Number K791088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date October 22, 1979
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
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 60
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K791088.
NU-CAP CALCIUM HYDROX. PULP CAPPING
K831575 · Coe Laboratories, Inc. · Jun 1983
IMPROVED DYCAL
K820215 · Dentsply Intl. · Mar 1982
REOLIT
K802685 · Vivadent (Usa), Inc. · Nov 1980
LINER, CAVITY CALCIUM HYDROXIDE
K781688 · Kerr Corporation (Danbury) · Dec 1978
IMPROVED DYCAL
K780384 · L.D. Caulk Co. · Mar 1978