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510(k) K851944

MAX-I-PROBE HANDPIECE by Solo Pak Laboratories — Product Code EIC

K851944 is an FDA 510(k) premarket notification submitted by Solo Pak Laboratories for the device "MAX-I-PROBE HANDPIECE". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Solo Pak Laboratories has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
May 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Periodontic, Endodontic, Irrigating
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Solo Pak Laboratories

  • K841306 — HEPARIN LOCK FLUSH SOLUTION USP KIT,100 (June 4, 1984)
  • K841166 — HEPARIN LOCK FLUSH PROCEDURE PACK (June 4, 1984)
  • K841305 — HEPARIN LOCK FLUSH SOLUTION USP KIT (June 4, 1984)

Other clearances for product code EIC

  • K972234 — RCT GEL ROOT CANAL THERAPY GEL (June 30, 1997)
  • K864307 — MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) (November 18, 1986)
  • K861846 — HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (June 26, 1986)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K811889 — R & S SERIES FITTING TOOLS (July 24, 1981)
  • K811594 — WATER PISTOL (July 15, 1981)
  • K801483 — MARK IV SYRINGE (July 21, 1980)
  • K801484 — ROOT CANAL FILLING APPLICATOR NEEDLES (July 21, 1980)
  • K792578 — EPIC CANNULA (January 4, 1980)
  • K792577 — ENDOVAGE SYRINGE (January 4, 1980)

FDA data resources