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510(k) K811594

WATER PISTOL by Aus-Tex Dental Mfg. & Design — Product Code EIC

K811594 is an FDA 510(k) premarket notification submitted by Aus-Tex Dental Mfg. & Design for the device "WATER PISTOL". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Aus-Tex Dental Mfg. & Design has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 8, 1981
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 Aus-Tex Dental Mfg. & Design

  • K771406 — GUTTA GUN (August 26, 1977)
  • K770813 — ENDOGATOR (May 20, 1977)

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)
  • K851944 — MAX-I-PROBE HANDPIECE (July 1, 1985)
  • K840237 — MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (April 5, 1984)
  • K811889 — R & S SERIES FITTING TOOLS (July 24, 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