510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061383Substantially Equivalent

Bti Sterile Dental Drills Kit, Bti Abutments and Caps

B.T.I. Biotechnology Institute, S.L., Minano(Alava), ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061383 is the FDA 510(k) clearance record for BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS, a class I device, cleared for B.T.I. Biotechnology Institute, Sl. on under FDA product code EJL (Bur, Dental). FDA records list 15 510(k) clearances for B.T.I. Biotechnology Institute, Sl., from to . As of , FDA records show no recalls naming K061383.

Clearance record

Decision date
Received
(77 days to decision)
Product code
EJL Bur, Dental
Regulation
21 CFR 872.3240
Device class
Class I
Review panel
Dental
Applicant
B.T.I. Biotechnology Institute, Sl. Parque Tecnologico De Alava, Minano(Alava), ES
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJL

Trailing 12 months

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

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