K863017Substantially Equivalent

Isolax (Gnatus)/isolax Pedal/minilax

Name: K863017 Isolax (Gnatus)/isolax Pedal/minilax
Creator: Sds Dental, Inc.
Published: 1986-09-25
License: https://open.fda.gov/license/

Sds Dental, Inc., Washington DC / Traditional, Substantially Equivalent

FDA source

K863017 is the FDA 510(k) clearance record for ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAX, cleared for Sds Dental, Inc. on 1986-09-25. FDA records list 21 510(k) clearances for Sds Dental, Inc., from 1986-09-24 to 1999-11-05. As of 2026-09-10, FDA records show no recalls naming K863017.

Clearance record

Decision date: 1986-09-25
Received: 1986-08-08 (48 days to decision)
Review panel: Unknown
Applicant: Sds Dental, Inc. 4321 Wisconsin Ave. N.W, Washington DC
Third party review: No