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510(k) K863768

SALIVA EJECTORS by The Medical Group, Inc. — Product Code DYN

K863768 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "SALIVA EJECTORS". The FDA issued a decision of Substantially Equivalent on October 27, 1986. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1986
Date Received
September 25, 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 The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870282 — 4 X 4 SPONGES, NON-STERILE (February 24, 1987)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K870285 — THERMOMETER SHEATHES, STERILE (GLASS) (February 12, 1987)
  • K863769 — EVACUATOR TIPS (October 30, 1986)
  • K863767 — GLASS MOUTH MIRRORS, REUSABLE (October 30, 1986)

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