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510(k) K940769

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR by Terraflex — Product Code DYN

K940769 is an FDA 510(k) premarket notification submitted by Terraflex for the device "DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
February 18, 1994
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 for product code DYN

  • 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)
  • K864300 — SILIVA EJECTOR/ORAL CAVITY EVACUATOR (November 24, 1986)
  • K863768 — SALIVA EJECTORS (October 27, 1986)

FDA data resources