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510(k) K150702

Exceed Tx by Great Lakes Orthodontics, Ltd. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2016
Date Received
March 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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  • K033632 — VARIFLEX (January 21, 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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