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510(k) K864300

SILIVA EJECTOR/ORAL CAVITY EVACUATOR by Ardent Intl., Inc. — Product Code DYN

K864300 is an FDA 510(k) premarket notification submitted by Ardent Intl., Inc. for the device "SILIVA EJECTOR/ORAL CAVITY EVACUATOR". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Ardent Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1986
Date Received
October 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Saliva Ejector
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Ardent Intl., Inc.

  • K842512 — EXACTA-FILM (June 27, 1984)
  • K832647 — ARTICULATING PAPER (February 21, 1984)

Other clearances for product code DYN

  • K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (August 17, 1994)
  • K935758 — HYGOFLEX SALIVA-EJECTOR (March 21, 1994)
  • K935616 — SALIVA EJECTOR DISPOSABLE (March 21, 1994)
  • K924211 — EJECTOR (March 31, 1993)
  • K920492 — HIGH VAC (May 11, 1992)
  • K921117 — MINIDAM (May 5, 1992)
  • K900631 — SALIVA ABSORBER - DENTAL (April 4, 1990)
  • K871315 — ORAL ASPIRATOR (April 15, 1987)
  • K870599 — TIP, DENTAL SUCTION APPARATUS (March 23, 1987)
  • K863768 — SALIVA EJECTORS (October 27, 1986)

FDA data resources