Home / 510(k) Clearances / K162543

510(k) K162543

Reverse Pull Adjustable Facemask by Sawbros Industries Pvt., Ltd. — Product Code DZB

K162543 is an FDA 510(k) premarket notification submitted by Sawbros Industries Pvt., Ltd. for the device "Reverse Pull Adjustable Facemask". The FDA issued a decision of Substantially Equivalent on August 28, 2017. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2017
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

Other clearances for product code DZB

  • K202855 — Orthodontic Facemask (June 21, 2021)
  • K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-P (October 3, 2011)
  • K103019 — KJ MASK (June 9, 2011)
  • K052553 — NITOM LOCKING FACEBOW (December 22, 2005)
  • K051751 — EQUA-PULL SAFETY RELEASE MODULE (July 22, 2005)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K032392 — MORALES PROTRACTION FACEMASK (October 22, 2003)
  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
  • K993224 — T-GEAR, MODEL TG/400-700 (February 11, 2000)
  • K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (September 4, 1998)

FDA data resources