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510(k) K781592

SURGICAL ASPIRATOR TIPS by Henry Schein, Inc. — Product Code DYN

K781592 is an FDA 510(k) premarket notification submitted by Henry Schein, Inc. for the device "SURGICAL ASPIRATOR TIPS". The FDA issued a decision of Substantially Equivalent on December 4, 1978. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Henry Schein, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1978
Date Received
September 18, 1978
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 Henry Schein, Inc.

  • K041580 — IMAGERAYI (June 29, 2004)
  • K862384 — SCHEIN AP-1 AIR POLISHING UNIT (November 7, 1986)
  • K862385 — SCHEIN BLEACHING UNIT (October 30, 1986)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K834055 — VANADIUM EXCAVATORS SIZES 0-6 (February 21, 1984)
  • K834056 — SCHEIN COTTON ROLLS, NON-STERILE (February 3, 1984)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)

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)
  • 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