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510(k) K922633

CAVI-ZYME by E&D Dental Products, Inc. — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1992
Date Received
May 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by E&D Dental Products, Inc.

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  • K912820 — POLYESTER RESIN HAND MOLDED TRAY (August 21, 1991)

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  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)
  • K981234 — FLARE,FILE, FILL (June 5, 1998)
  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)
  • K823913 — SOFT GRIP UNI-HANDLE (January 26, 1983)