510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910135Substantially Equivalent

The Universal Cement Plug(tm)

Biotron, Ltd., Tequesta FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910135 is the FDA 510(k) clearance record for THE UNIVERSAL CEMENT PLUG(TM), a class II device, cleared for Biotron , Ltd. on under FDA product code LZN (Cement Obturator). FDA records list 5 510(k) clearances for Biotron , Ltd., from to . As of , FDA records show no recalls naming K910135.

Clearance record

Decision date
Received
(55 days to decision)
Product code
LZN Cement Obturator
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biotron , Ltd. 17465 SE Conch Bar Ave., Tequesta FL
Third party review
No

Clearances, product code LZN

Trailing 12 months

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

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