Cleared Traditional

K001541 - MINICAM

K001541 is an FDA 510(k) clearance for MINICAM, manufactured by Video Dental Concepts, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K001541 · Video Dental Concepts, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
65d
Days
Class 1
Risk

K001541 is an FDA 510(k) clearance for the MINICAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Video Dental Concepts, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 65 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 Video Dental Concepts, Inc. devices

FDA 510(k) Submission Details - K001541

510(k) Number K001541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2000
Decision Date July 21, 2000
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
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 148
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K001541.
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217 · Aseptico, Inc. · Oct 2002
SOPRO595 INTRA ORAL CAMERA
K012505 · Sopro · Oct 2001
MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
K003090 · Midmark Corp. · Oct 2000
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