NIL— 510(k) K935687

Substantially Equivalent

Dentalsafe Systems Pty., Ltd.

FDA 510(k) clearance K935687 for NIL, Substantially Equivalent on 1994-02-03. Applicant: Dentalsafe Systems Pty., Ltd.. Device class: 1.

Clearance details

Applicant: Dentalsafe Systems Pty., Ltd.
Product code: Code EAX
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1993-11-29
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, Australia, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code EAX

K946073 — ORALVUE DENTAL MIRROR1995-02-16
K935906 — RANIR PLAX RX1994-09-02
K941574 — RETRO MIRROR1994-05-18
K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY1986-10-30
K863767 — GLASS MOUTH MIRRORS, REUSABLE1986-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.