Cleared Traditional

K791326 - MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL

K791326 is an FDA 510(k) clearance for MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL, manufactured by Sherwood Medical Co.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K791326 · Sherwood Medical Co. · Dental device
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Oct 1979
Decision
97d
Days
Class 2
Risk

K791326 is an FDA 510(k) clearance for the MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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 - K791326

510(k) Number K791326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date October 17, 1979
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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.