510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000213Substantially Equivalent

Jeldent Basic Line

J.F. Jelenko & Co., Inc., Armonk NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000213 is the FDA 510(k) clearance record for JELDENT BASIC LINE, a class II device, cleared for J.F. Jelenko & Co. on under FDA product code ELM (Denture, Plastic, Teeth). FDA records list 56 510(k) clearances for J.F. Jelenko & Co., from to . As of , FDA records show no recalls naming K000213.

Clearance record

Decision date
Received
(73 days to decision)
Product code
ELM Denture, Plastic, Teeth
Regulation
21 CFR 872.3590
Device class
Class II
Review panel
Dental
Applicant
J.F. Jelenko & Co. 99 Business Park Dr., Armonk NY
510(k) summary
Statement
Third party review
No

Clearances, product code ELM

Trailing 12 months

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

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