510(k) K031421 ยท ELC Scaler, Ultrasonic
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
| Applicant | Nakanishi, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, Mar 26, 2004 |
| Received | May 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150).
The intended use of the tips is based on the parent device. For the ult Terminated |
ELC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.