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510(k) K170596

TN-Brush by Genoss Co., Ltd. — Product Code ELB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2017
Date Received
February 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Rotary
Device Class
Class II
Regulation Number
872.4840
Review Panel
DE
Submission Type

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Other clearances for product code ELB

  • K121114 — TIGRAN PERIBRUSH (September 17, 2012)
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  • K003640 — MINIENDO III (February 22, 2001)
  • K831037 — AIR BURBINE HANDPIECE-DENTAL SCALING (May 9, 1983)
  • K782007 — ROTARY SCALER (January 3, 1979)