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510(k) K073478

SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS by Sybron Dental Specialties, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2008
Date Received
December 11, 2007
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

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  • K151332 — Nexus Universal, Nexus Universal Chroma (August 17, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)

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