510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834363Substantially Equivalent

Endix Radicular Bioceramic Pin

C.B.S. Biotechnics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834363 is the FDA 510(k) clearance record for ENDIX RADICULAR BIOCERAMIC PIN, a class II device, cleared for C.B.S. Biotechnics, Inc. on under FDA product code ELS (Splint, Endodontic Stabilizing). FDA records list 4 510(k) clearances for C.B.S. Biotechnics, Inc., from to . As of , FDA records show no recalls naming K834363.

Clearance record

Decision date
Received
(123 days to decision)
Product code
ELS Splint, Endodontic Stabilizing
Regulation
21 CFR 872.3890
Device class
Class II
Review panel
Dental
Applicant
C.B.S. Biotechnics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ELS

Trailing 12 months

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

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