GUM MASSAGER— 510(k) K911418

Substantially Equivalent

Burn-Henderson Partnership

FDA 510(k) clearance K911418 for GUM MASSAGER, Substantially Equivalent on 1991-07-17. Applicant: Burn-Henderson Partnership. Device class: 1.

Clearance details

Applicant: Burn-Henderson Partnership
Product code: Code JET
Device class: Class 1
Regulation: 21 CFR 872.6650
Advisory panel: Dental
Date received: 1991-04-01
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JET

K963747 — REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.1996-12-16
K942633 — ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE1995-04-27
K930178 — ELECTRO FLOSS1993-07-28
K885189 — MASSAGING PICK FOR ORAL HYGIENE1989-03-17
K890910 — PLAKOF1989-03-16

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