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510(k) K924211

EJECTOR by Glenroe Technologies — Product Code DYN

K924211 is an FDA 510(k) premarket notification submitted by Glenroe Technologies for the device "EJECTOR". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Glenroe Technologies has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
August 20, 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 by Glenroe Technologies

  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K945535 — GLENROE ORTHO-SIL (January 27, 1995)
  • K924351 — GLENROE ELASTIBITE STIMULATOR (January 6, 1994)
  • K932920 — GLENROE PLASTIC BRACKET (August 24, 1993)
  • K931462 — GLENROE CHAIN (July 22, 1993)
  • K924140 — TUFF TIES (April 27, 1993)
  • K924139 — GLENROE ORTHO SEPS (April 8, 1993)
  • K924993 — GLENROE BAND SEATING CONTOURING INSTRUMENT (November 25, 1992)

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)
  • 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