510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060347Substantially Equivalent

B&l L-Beta, Model Wl-B1

B&L Biotech Co., Inc, Deer Field IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060347 is the FDA 510(k) clearance record for B&L L-BETA, MODEL WL-B1, a class I device, cleared for B&L Biotech Co., Ltd. on under FDA product code EKR (Plugger, Root Canal, Endodontic). FDA records list one 510(k) clearance for B&L Biotech Co., Ltd. As of , FDA records show no recalls naming K060347.

Clearance record

Decision date
Received
(115 days to decision)
Product code
EKR Plugger, Root Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
B&L Biotech Co., Ltd. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKR

Trailing 12 months

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

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