Cleared Traditional

K821273 - MAYO SCISSOR STRAIGHT 6 3/4 (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821273 · Conphar, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
25d
Days
Class 2
Risk

K821273 is an FDA 510(k) clearance for the MAYO SCISSOR STRAIGHT 6 3/4. Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conphar, Inc. devices

Submission Details

510(k) Number K821273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date May 28, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
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.