Home / 510(k) Clearances / K944848

510(k) K944848

THE VIVACARE T.P.S. PROBE by Rms Div. — Product Code EIX

K944848 is an FDA 510(k) premarket notification submitted by Rms Div. for the device "THE VIVACARE T.P.S. PROBE". The FDA issued a decision of Substantially Equivalent on December 14, 1994. The device falls under product code EIX (Probe, Periodontic), a Class I device regulated under 21 CFR 872.4565. Rms Div. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1994
Date Received
September 30, 1994
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 by Rms Div.

  • K963367 — RMS K-WIRE (October 30, 1996)
  • K954438 — SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE (December 29, 1995)
  • K944557 — DW250 #91 (November 3, 1994)
  • K941625 — DW234 #29 (June 22, 1994)
  • K902403 — ELITE R/F SPOT FILM DRIVE (August 1, 1990)
  • K902146 — SFD-035 SPOT FILM DEVICE (May 31, 1990)
  • K896665 — EXT-600 TABLE, RADIOGRAPHIC, ELEVATING (January 22, 1990)
  • K896119 — RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (November 27, 1989)
  • K896324 — ELITE 1500 RADIOGRAPHIC TILTING TABLE (November 21, 1989)

Other clearances for product code EIX

  • K960245 — VIP VICTOR INTERACTIVE PROBE (April 4, 1996)
  • 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)
  • K871504 — DISPOSABLE PERIODONTAL PROBE (May 6, 1987)
  • K823324 — DENTAL INSTRUMENTS - PROBES (November 24, 1982)

FDA data resources