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510(k) K761264

OPTIONS FOR STAR DENTAL OPUS I by Syntex Corp. — Product Code DYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1976
Date Received
December 16, 1976
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 Syntex Corp.

  • K920314 — TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (April 17, 1992)
  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K780997 — AMALGAM ALLOY (July 27, 1978)
  • K780769 — S-100 CT SCANNER (June 2, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

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)