Cleared Traditional

K994211 - ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K994211 · Dentsply Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
52d
Days
Class 2
Risk

K994211 is an FDA 510(k) clearance for the ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Dentsply Intl. (Des Plaines, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device 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 Dentsply Intl. devices

Submission Details

510(k) Number K994211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date February 04, 2000
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 128d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.