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510(k) K780483

FIBER OPTIC HANDPIECE by Syntex Corp. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1978
Date Received
March 27, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
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)
  • 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)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

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