J.F. Jelenko & Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 56
What J.F. Jelenko & Co., Inc. makes
J.F. Jelenko & Co., Inc. manufactures dental casting alloys, including palladium-based alloys for porcelain applications, and dental investment materials used in crown and bridge fabrication. Their portfolio includes bench-top furnaces (e.g., BENCHMARK I, LEGACY-XT) for heat treatment, as well as temperature control systems (e.g., JELTEMP) for dental labs. Additional products encompass dental bonding agents (e.g., MAINBOND A), high-noble alloys (e.g., SIGNUM), and specialized casting systems (e.g., SYMPHONY).
The company’s devices are classified under Class II in the U.S. and are listed via 510(k) clearance with the FDA. Their products are regulated under the U.S. Food and Drug Administration’s dental device framework, ensuring compliance with performance and safety standards for laboratory and clinical use.
Catalogue
Search and filter all 56 devicesPtm-45 Ref K881861
Regimes: 510(k) Registry: 510(k)Jel Bios 10 (Code Name Rd-1801) Ref K993136
Regimes: 510(k) Registry: 510(k)Allround-E (Code Name Rd 1710) Ref K984587
Regimes: 510(k) Registry: 510(k)Olympia Ii Ref K881860
Regimes: 510(k) Registry: 510(k)Hp-3 Ref K923718
Regimes: 510(k) Registry: 510(k)Jeldent Multicryl Ref K990056
Regimes: 510(k) Registry: 510(k)
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