Cleared Traditional

K883775 - PORTABLE II DENTAL DELIVERY SYSTEM

K883775 is an FDA 510(k) clearance for PORTABLE II DENTAL DELIVERY SYSTEM, manufactured by Dntl Corp.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K883775 · Dntl Corp. · Dental device
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Oct 1988
Decision
38d
Days
Class 1
Risk

K883775 is an FDA 510(k) clearance for the PORTABLE II DENTAL DELIVERY SYSTEM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dntl Corp. (Englewood, US). The FDA issued a Cleared decision on October 14, 1988 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Dntl Corp. devices

FDA 510(k) Submission Details - K883775

510(k) Number K883775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1988
Decision Date October 14, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 189
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K883775.
A-DEC DECADE CUSPIDOR
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SUCTION ORA-SWAB(R) BRUSH KIT
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DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · Aseptico, Inc. · Dec 1988
CM-II, CM-I WATER UNIT
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EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · Sds Dental, Inc. · Sep 1986
CABINET II AUXILIARY UNIT
K863023 · Sds Dental, Inc. · Sep 1986