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510(k) K792577

ENDOVAGE SYRINGE by Dental Development Services, Inc. — Product Code EIC

K792577 is an FDA 510(k) premarket notification submitted by Dental Development Services, Inc. for the device "ENDOVAGE SYRINGE". The FDA issued a decision of Substantially Equivalent on January 4, 1980. The device falls under product code EIC (Syringe, Periodontic, Endodontic, Irrigating), a Class I device regulated under 21 CFR 872.4565. Dental Development Services, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1980
Date Received
December 14, 1979
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 Dental Development Services, Inc.

  • K792578 — EPIC CANNULA (January 4, 1980)

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)
  • 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)

FDA data resources