DEN-Z-ORB— 510(k) K780400

Substantially Equivalent

Nice-Pak Products, Inc.

FDA 510(k) clearance K780400 for DEN-Z-ORB, Substantially Equivalent on 1978-03-27. Applicant: Nice-Pak Products, Inc.. Device class: 1.

Clearance details

Applicant: Nice-Pak Products, Inc.
Product code: Code KHR
Device class: Class 1
Regulation: 21 CFR 872.6050
Advisory panel: Dental
Date received: 1978-03-13
Decision date: 1978-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHR

K980783 — SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-51998-04-21
K954068 — GENERAL HYGIENE KIT1995-11-08
K953812 — GAUZE SPONGE1995-10-02
K891054 — NON-STERILE GAUZE SPONGE1989-05-01
K891354 — ORTHODONTIC COTTON ROLL HOLDERS1989-04-17

More clearances from Nice-Pak Products, Inc.

K974768 — PDI STERILE LUBRICATING JELLY1998-01-16
K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT1984-03-27
K840343 — PDI PREPMASTER WET PACK VAGINAL-X214771984-03-27
K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE1984-03-26
K833549 — PDI SURGICAL SCRUB/BRUSH T150-701983-11-28

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