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510(k) K982088

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM by Ortho Kinetics Corp. — Product Code DZB

K982088 is an FDA 510(k) premarket notification submitted by Ortho Kinetics Corp. for the device "AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500. Ortho Kinetics Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
June 15, 1998
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 by Ortho Kinetics Corp.

  • K980436 — CLASS III REVERSE PULL FACEMASK (April 27, 1998)
  • K980245 — NITOM LOCKING FACEBOW (April 21, 1998)
  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980151 — RELEASABLE FORCE MODULE (April 6, 1998)
  • K980195 — FACEBOW (March 11, 1998)
  • K940410 — NEW GEAR RELEASABLE HEADGEAR (March 10, 1994)

Other clearances for product code DZB

  • K202855 — Orthodontic Facemask (June 21, 2021)
  • K162543 — Reverse Pull Adjustable Facemask (August 28, 2017)
  • 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)

FDA data resources