510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983266Substantially Equivalent

Fibrekor Post System

Jeneric/Pentron, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983266 is the FDA 510(k) clearance record for FIBREKOR POST SYSTEM, a class I device, cleared for Jeneric/Pentron, Inc. on under FDA product code ELR (Post, Root Canal). FDA records list 78 510(k) clearances for Jeneric/Pentron, Inc., from to . As of , FDA records show no recalls naming K983266.

Clearance record

Decision date
Received
(53 days to decision)
Product code
ELR Post, Root Canal
Regulation
21 CFR 872.3810
Device class
Class I
Review panel
Dental
Applicant
Jeneric/Pentron, Inc. 53 N. Plains Industrial Rd., Wallingford CT
510(k) summary
Statement
Third party review
No

Clearances, product code ELR

Trailing 12 months

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

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