Cleared Traditional

K043325 - ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES

K043325 is an FDA 510(k) clearance for ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCE..., manufactured by Rolence Enteprise, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K043325 · Rolence Enteprise, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
71d
Days
Class 1
Risk

K043325 is an FDA 510(k) clearance for the ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Rolence Enteprise, Inc. (Chungi, TW). The FDA issued a Cleared decision on February 11, 2005 after a review of 71 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 Rolence Enteprise, Inc. devices

FDA 510(k) Submission Details - K043325

510(k) Number K043325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date February 11, 2005
Days to Decision 71 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
56d faster than avg
Panel avg: 127d · This submission: 71d
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 155
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K043325.
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · A-Dec, Inc. · Aug 2005
AEU-14CF EXPENDITION
K050201 · Aseptico, Inc. · Mar 2005
SPACELINE EMCIA, MODEL CU580
K043496 · J. Morita USA, Inc. · Feb 2005
COCOON HYGIENIST
K040529 · Satelec · Aug 2004
STV PRO 2
K033419 · Trophy Radiologie · Feb 2004
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757 · A-Dec, Inc. · Dec 2003