510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991564Substantially Equivalent

Jeltemp

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

K991564 is the FDA 510(k) clearance record for JELTEMP, a class II device, cleared for J.F. Jelenko & Co., Inc. on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 56 510(k) clearances for J.F. Jelenko & Co., Inc., from to . As of , FDA records show no recalls naming K991564.

Clearance record

Decision date
Received
(49 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
J.F. Jelenko & Co., Inc. 99 Business Park Dr., Armonk NY
510(k) summary
Statement
Third party review
No

Clearances, product code EBG

Trailing 12 months
2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260