Cleared Traditional

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

K002693 · Cbs Intl. B.V. · Dental device

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). This device is classified as a Pin, Retentive And Splinting, And Accessory Instruments (Class I - General Controls, product code EBL).

Submitted by Cbs Intl. B.V. (Almere, NL). The FDA issued a Cleared decision on November 9, 2000, 72 days after receiving the submission on August 29, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3740.

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