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510(k) K801927

SILENTSLEEP by Slumber Research, Inc. — Product Code DYN

K801927 is an FDA 510(k) premarket notification submitted by Slumber Research, Inc. for the device "SILENTSLEEP". The FDA issued a decision of Substantially Equivalent on November 14, 1980. 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
November 14, 1980
Date Received
August 12, 1980
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)
  • 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)

FDA data resources