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510(k) K871504

DISPOSABLE PERIODONTAL PROBE by Periodontal Health Brush, Inc. — Product Code EIX

K871504 is an FDA 510(k) premarket notification submitted by Periodontal Health Brush, Inc. for the device "DISPOSABLE PERIODONTAL PROBE". The FDA issued a decision of Substantially Equivalent on May 6, 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
May 6, 1987
Date Received
April 17, 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)
  • K870280 — ACCUDENT ACCUPROBE (June 8, 1987)
  • K823324 — DENTAL INSTRUMENTS - PROBES (November 24, 1982)

FDA data resources