510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872471Substantially Equivalent

Titane Sl Dental Burr

Titane SL Co., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872471 is the FDA 510(k) clearance record for TITANE SL DENTAL BURR, a class I device, cleared for Titane SL Co. on under FDA product code ECM (Band, Preformed, Orthodontic). FDA records list one 510(k) clearance for Titane SL Co. As of , FDA records show no recalls naming K872471.

Clearance record

Decision date
Received
(80 days to decision)
Product code
ECM Band, Preformed, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Titane SL Co. Suite 1109, Minneapolis MN
Third party review
No

Clearances, product code ECM

Trailing 12 months

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

FDA records show no clearances under product code ECM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ECM, 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