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510(k) K880827

ACCUTEK PERIODONTAL PROBE by Sweet Micro Systems, Inc. — Product Code EIX

K880827 is an FDA 510(k) premarket notification submitted by Sweet Micro Systems, Inc. for the device "ACCUTEK PERIODONTAL PROBE". The FDA issued a decision of Substantially Equivalent on April 12, 1988. 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
April 12, 1988
Date Received
March 1, 1988
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)
  • 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