JELTEMP— 510(k) K991564

Substantially Equivalent

J.F. Jelenko & Co., Inc.

FDA 510(k) clearance K991564 for JELTEMP, Substantially Equivalent on 1999-06-23. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.

Clearance details

Applicant: J.F. Jelenko & Co., Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1999-05-05
Decision date: 1999-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from J.F. Jelenko & Co., Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.