Cleared Traditional

K911118 - DTF-1000LL,DTF-1000

K911118 is an FDA 510(k) clearance for DTF-1000LL, manufactured by Cp Medical. The device is a Class 1 Dental device with product code EIB cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K911118 · Cp Medical · Dental device
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Nov 1991
Decision
253d
Days
Class 1
Risk

K911118 is an FDA 510(k) clearance for the DTF-1000LL,DTF-1000. Classified as Syringe, Irrigating (dental) (product code EIB), Class I - General Controls.

Submitted by Cp Medical (Huntington Beach, US). The FDA issued a Cleared decision on November 20, 1991 after a review of 253 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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.

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FDA 510(k) Submission Details - K911118

510(k) Number K911118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1991
Decision Date November 20, 1991
Days to Decision 253 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
126d slower than avg
Panel avg: 127d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

EIB Device Classification - Class 1, General Controls

Product Code EIB Syringe, Irrigating (dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.