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510(k) K833338

TOOTH SLOOTH by Joel Lander D.D.S. — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1983
Date Received
September 27, 1983
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

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  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K823913 — SOFT GRIP UNI-HANDLE (January 26, 1983)