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510(k) K781594

DENTAL WARM WATER IRRIGATING SYSTEM by Rama Corp. — Product Code ECB

K781594 is an FDA 510(k) premarket notification submitted by Rama Corp. for the device "DENTAL WARM WATER IRRIGATING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
September 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances for product code ECB

  • K942519 — UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (August 23, 1994)
  • K931772 — SURETIP SYRINGE TIP COVER (March 7, 1994)
  • K931137 — DENTAL SYRINGE TIP (November 29, 1993)
  • K923876 — RISKONTROL SINGLE USE (April 5, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 1992)
  • K920499 — SANI-TIP (May 3, 1992)
  • K911756 — POSTERIOR NASAL EPISTAXIS INSTRUMENTS (October 24, 1991)
  • K890290 — BRACE (ORAFIX SPECIAL) (March 29, 1989)
  • K863024 — SERINGA TRIPLICE S.L. (September 25, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

FDA data resources