SENTRY BREAKWAY NECK STRAP— 510(k) K862538

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K862538 for SENTRY BREAKWAY NECK STRAP, Substantially Equivalent on 1986-07-11. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1986-07-02
Decision date: 1986-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

K202855 — Orthodontic Facemask2021-06-21
K162543 — Reverse Pull Adjustable Facemask2017-08-28
K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF2011-10-03
K103019 — KJ MASK2011-06-09
K052553 — NITOM LOCKING FACEBOW2005-12-22

More clearances from Ormco Corp.

K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM2014-12-05
K123118 — INSIGNIA DIGICAST2013-03-26
K123416 — INSIGNIA WITH ITERO2013-03-13
K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE2013-02-08
K121524 — INSIGNIA2012-08-09

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