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510(k) K920492

HIGH VAC by Hygoplastic, Inc. — Product Code DYN

K920492 is an FDA 510(k) premarket notification submitted by Hygoplastic, Inc. for the device "HIGH VAC". The FDA issued a decision of Substantially Equivalent on May 11, 1992. 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
May 11, 1992
Date Received
February 3, 1992
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

  • 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)
  • 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