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510(k) K861846

HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT by Solar Dental Co., Inc. — Product Code EIC

K861846 is an FDA 510(k) premarket notification submitted by Solar Dental Co., Inc. for the device "HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT". The FDA issued a decision of Substantially Equivalent on June 26, 1986. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Solar Dental Co., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1986
Date Received
May 13, 1986
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 Solar Dental Co., Inc.

  • K871980 — D-23 DENTURE ADHESIVE (June 5, 1987)
  • K852926 — DENTOLOCK II DENTURE ADHESIVE CREAM (August 23, 1985)
  • K831294 — SOLARCRY/TEMPORARY CROWN & BRIDGE MAT (August 31, 1983)
  • K831293 — SOLARCRYL CUSTOM TRAY MATERIAL (July 26, 1983)
  • K831265 — DENTOLOCK DENTURE ADHESIVE CREAM (May 9, 1983)

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)
  • 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)
  • 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