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510(k) K870280

ACCUDENT ACCUPROBE by Accudent, Inc. — Product Code EIX

K870280 is an FDA 510(k) premarket notification submitted by Accudent, Inc. for the device "ACCUDENT ACCUPROBE". The FDA issued a decision of Substantially Equivalent on June 8, 1987. The device falls under product code EIX (Probe, Periodontic), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1987
Date Received
January 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Periodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code EIX

  • K960245 — VIP VICTOR INTERACTIVE PROBE (April 4, 1996)
  • K944848 — THE VIVACARE T.P.S. PROBE (December 14, 1994)
  • K936221 — PROBE TIP/PERI PROBE/PERI PROBE COMP. (August 1, 1994)
  • K890333 — ALBUMIN REAGENT (February 17, 1989)
  • K880827 — ACCUTEK PERIODONTAL PROBE (April 12, 1988)
  • K875076 — FLORIDA PROBE (March 10, 1988)
  • K871504 — DISPOSABLE PERIODONTAL PROBE (May 6, 1987)
  • K823324 — DENTAL INSTRUMENTS - PROBES (November 24, 1982)

FDA data resources