Cleared Traditional

CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (K002693) - FDA 510(k) Clearance

Class I Dental device.

K002693 · Cbs Intl. B.V. · Dental device
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Nov 2000
Decision
72d
Days
Class 1
Risk

K002693 is an FDA 510(k) clearance for the CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS). Classified as Pin, Retentive And Splinting, And Accessory Instruments (product code EBL), Class I - General Controls.

Submitted by Cbs Intl. B.V. (Almere, NL). The FDA issued a Cleared decision on November 9, 2000 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3740 - 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 Cbs Intl. B.V. devices

Submission Details

510(k) Number K002693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2000
Decision Date November 09, 2000
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBL Pin, Retentive And Splinting, And Accessory Instruments
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3740
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.