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510(k) K900631

SALIVA ABSORBER - DENTAL by Kab Gloves Unltd. — Product Code DYN

K900631 is an FDA 510(k) premarket notification submitted by Kab Gloves Unltd. for the device "SALIVA ABSORBER - DENTAL". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Kab Gloves Unltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
February 8, 1990
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 Kab Gloves Unltd.

  • K900135 — CU-75 VISIBLE LIGHT-CURING UNIT (May 7, 1990)
  • K900089 — FG DIAMOND BURRS (April 3, 1990)
  • K900088 — MASKS SURGICAL DENTAL (March 8, 1990)

Other clearances for product code DYN

  • K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (August 17, 1994)
  • K935616 — SALIVA EJECTOR DISPOSABLE (March 21, 1994)
  • K935758 — HYGOFLEX SALIVA-EJECTOR (March 21, 1994)
  • K924211 — EJECTOR (March 31, 1993)
  • K920492 — HIGH VAC (May 11, 1992)
  • K921117 — MINIDAM (May 5, 1992)
  • 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