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510(k) K936221

PROBE TIP/PERI PROBE/PERI PROBE COMP. by Pd International AB — Product Code EIX

K936221 is an FDA 510(k) premarket notification submitted by Pd International AB for the device "PROBE TIP/PERI PROBE/PERI PROBE COMP.". The FDA issued a decision of Substantially Equivalent on August 1, 1994. 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
August 1, 1994
Date Received
December 27, 1993
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)
  • K890333 — ALBUMIN REAGENT (February 17, 1989)
  • K880827 — ACCUTEK PERIODONTAL PROBE (April 12, 1988)
  • K875076 — FLORIDA PROBE (March 10, 1988)
  • K870280 — ACCUDENT ACCUPROBE (June 8, 1987)
  • K871504 — DISPOSABLE PERIODONTAL PROBE (May 6, 1987)
  • K823324 — DENTAL INSTRUMENTS - PROBES (November 24, 1982)

FDA data resources