Cleared Traditional

K010926 - R-SI-LINE METAL-BITE

K010926 is an FDA 510(k) clearance for R-SI-LINE METAL-BITE, manufactured by R-Dental Dentalerzeugnisse GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K010926 · R-Dental Dentalerzeugnisse GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
16d
Days
Class 2
Risk

K010926 is an FDA 510(k) clearance for the R-SI-LINE METAL-BITE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by R-Dental Dentalerzeugnisse GmbH (Hamburg, DE). The FDA issued a Cleared decision on April 12, 2001 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 R-Dental Dentalerzeugnisse GmbH devices

FDA 510(k) Submission Details - K010926

510(k) Number K010926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2001
Decision Date April 12, 2001
Days to Decision 16 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 305
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K010926.
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001
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CAVEX COLORCHANGE
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TAKE 1
K003808 · Sybron Dental Specialties, Inc. · Mar 2001
PERMLASTIC 3
K003650 · Sybron Dental Specialties, Inc. · Feb 2001
FLEXTIME MAGNUM 360
K003930 · Heraeus Kulzer, Inc. · Feb 2001