Cleared Traditional

K964810 - DERMADAM

K964810 is an FDA 510(k) clearance for DERMADAM, manufactured by Ultradent Products, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K964810 · Ultradent Products, Inc. · Dental device
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Feb 1997
Decision
73d
Days
Class 1
Risk

K964810 is an FDA 510(k) clearance for the DERMADAM. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 10, 1997 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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.

FDA 510(k) Submission Details - K964810

510(k) Number K964810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date February 10, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 128d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.

Regulatory Peers - EFS Unit, Oral Irrigation

All 44
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K964810 · DERMADAM
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