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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 Nov 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 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 24, 1986
Date Received
Oct 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
510(k) Exempt

Other clearances by Ardent Intl., Inc.

  • K842512 — EXACTA-FILM (Jun 27, 1984)
  • K832647 — ARTICULATING PAPER (Feb 21, 1984)

Other clearances for product code DYN

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

FDA data resources

Source: FDA 510(k) database entry for K864300. Report a data issue: hello@regdatalab.com.