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510(k) K121114

TIGRAN PERIBRUSH by Tigran Technologies AB — Product Code ELB

K121114 is an FDA 510(k) premarket notification submitted by Tigran Technologies AB for the device "TIGRAN PERIBRUSH". The FDA issued a decision of Substantially Equivalent on September 17, 2012. The device falls under product code ELB (Scaler, Rotary), a Class II device regulated under 21 CFR 872.4840.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2012
Date Received
April 12, 2012
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

Other clearances for product code ELB

  • K170596 — TN-Brush (September 11, 2017)
  • K111724 — STRAUMANN TIBRUSH (September 12, 2011)
  • K003640 — MINIENDO III (February 22, 2001)
  • K831037 — AIR BURBINE HANDPIECE-DENTAL SCALING (May 9, 1983)
  • K782007 — ROTARY SCALER (January 3, 1979)

FDA data resources