510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870032Substantially Equivalent

Revised T-Scan System

Sentek, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870032 is the FDA 510(k) clearance record for REVISED T-SCAN SYSTEM, a class I device, cleared for Sentek, Inc. on under FDA product code EFH (Paper, Articulation). FDA records list one 510(k) clearance for Sentek, Inc. As of , FDA records show no recalls naming K870032.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EFH Paper, Articulation
Regulation
21 CFR 872.6140
Device class
Class I
Review panel
Dental
Applicant
Sentek, Inc. Third Floor, Washington DC
Third party review
No

Clearances, product code EFH

Trailing 12 months

FDA records hold no clearances under product code EFH in the trailing twelve months.

FDA records show no clearances under product code EFH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260