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510(k) K071615

FIXAFLOSS by Sybron Dental Specialties, Inc. — Product Code EEF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2007
Date Received
June 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Rubber Dam
Device Class
Class I
Regulation Number
872.6300
Review Panel
DE
Submission Type

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Other clearances for product code EEF

  • K915207 — DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (February 14, 1992)
  • K780744 — BRINKER TISSUE RETRACTORS (May 12, 1978)