Cleared Traditional

K032070 - ELCACAM

K032070 is the FDA 510(k) clearance for ELCACAM by A-Dec, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K032070 · A-Dec, Inc. · Dental device
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Aug 2003
Decision
55d
Days
Class 1
Risk

K032070 is an FDA 510(k) clearance for the ELCACAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on August 27, 2003 after a review of 55 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 A-Dec, Inc. devices

Submission Details

510(k) Number K032070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2003
Decision Date August 27, 2003
Days to Decision 55 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
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 60
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K032070.
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
K032756 · A-Dec, Inc. · Dec 2003
SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
K032543 · Sirona Dental Systems GmbH · Nov 2003
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
K032904 · Dentsply Intl. · Oct 2003
4631 DUO DELIVERY SYSTEM
K000966 · A-Dec, Inc. · May 2000
4635 ASSISTANT'S INSTRUMENTATION
K000967 · A-Dec, Inc. · May 2000
3181 DUO DELIVERY SYSTEM
K000968 · A-Dec, Inc. · May 2000