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510(k) K033632

VARIFLEX by Great Lakes Orthodontics, Ltd. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2004
Date Received
November 19, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Great Lakes Orthodontics, Ltd.

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  • K150702 — Exceed Tx (March 24, 2016)
  • K083479 — BIOCRYL X (February 27, 2009)
  • K041718 — KELES FACEMASK (October 15, 2004)
  • K040881 — METACRYL (May 25, 2004)
  • K922818 — SNORE-NO-MORE (February 9, 1994)
  • K925275 — SOFT DENTURE RELINE MATERIAL ELASTOLINE (January 11, 1993)
  • K870908 — STEADY RESIN (March 19, 1987)
  • K861424 — ADAPTABLE CLASS III MASK (May 29, 1986)
  • K840805 — ORAL SAFE (March 30, 1984)

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  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)