Cleared Traditional

K822610 - PRECAPSULED DENTAL AMALGAM

K822610 is an FDA 510(k) clearance for PRECAPSULED DENTAL AMALGAM, manufactured by Syntex Dental Products, Inc.. The device is a Class 1 Dental device with product code DZS cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K822610 · Syntex Dental Products, Inc. · Dental device
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Sep 1982
Decision
15d
Days
Class 1
Risk

K822610 is an FDA 510(k) clearance for the PRECAPSULED DENTAL AMALGAM. Classified as Capsule, Dental, Amalgam (product code DZS), Class I - General Controls.

Submitted by Syntex Dental Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3110 - 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 Syntex Dental Products, Inc. devices

FDA 510(k) Submission Details - K822610

510(k) Number K822610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1982
Decision Date September 14, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

DZS Device Classification - Class 1, General Controls

Product Code DZS Capsule, Dental, Amalgam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.