ORTHODONTIC FACE BOW W/ INNER WIRE— 510(k) K920784

Name: FDA 510(k) clearance K920784
Creator: U.S. Food and Drug Administration
Published: 1992-03-20

Substantially Equivalent

Gac Intl., Inc.

FDA 510(k) clearance K920784 for ORTHODONTIC FACE BOW W/ INNER WIRE, Substantially Equivalent on 1992-03-20. Applicant: Gac Intl., Inc.. Device class: 2.

Clearance details

Applicant: Gac Intl., Inc.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1992-02-20
Decision date: 1992-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

view all

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 Gac Intl., Inc.

view all

K981036 — SMARTBOND1999-04-05
K942826 — ORTHODONITC METAL REINFORCED PLASTIC BRACKET1994-12-14
K933542 — MESIAL LOOP BAR1994-08-05
K932825 — MICROARCH GOLD BRACKET1994-05-09
K932319 — ORTHODONTIC ELASTOMER1993-09-20

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