Cleared Abbreviated

K070663 - A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT (FDA 510(k) Clearance)

K070663 · A-Dec, Inc. · Dental device

Jul 2007

Decision

118d

Days

Class 1

Risk

K070663 is an FDA 510(k) clearance for the A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on July 5, 2007, 118 days after receiving the submission on March 9, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K070663 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 09, 2007
Decision Date	July 05, 2007
Days to Decision	118 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF