Cleared Traditional

K884828 - HANDIDAM

K884828 is an FDA 510(k) clearance for HANDIDAM, manufactured by Aseptico, Inc.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K884828 · Aseptico, Inc. · Dental device
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Feb 1989
Decision
77d
Days
Class 1
Risk

K884828 is an FDA 510(k) clearance for the HANDIDAM. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Aseptico, Inc. (Kirkland, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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 - K884828

510(k) Number K884828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date February 03, 1989
Days to Decision 77 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
51d faster than avg
Panel avg: 128d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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 - EIE Dam, Rubber

All 28
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K884828.
MADEGOM LTDA. DENTAL DAM
K894120 · Madegom · Aug 1989
KITCHIN DENTAL ABCESS DRAIN
K885231 · Kitchin, Inc. · May 1989
RUBBER DAM
K890667 · Cost Rite Health Products, Inc. · Mar 1989
DREAM DAM
K875255 · Dental Dam, Inc. · Mar 1988
DREAM DAM
K864096 · Dental Dam, Inc. · Nov 1986
IVORY PREMIUM RUBBER DAM
K863816 · Columbus Dental Mfg. Co. · Oct 1986
K884828 · HANDIDAM
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