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J.F. Jelenko & Co., Inc.

Also registered as J.F. Jelenko & Co.

United StatesFDA 510(k) 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.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue56

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  • Rd-2104 Ref K002222

    Class II
    Active 510(k) 510(k) II

  • Palladium-Based Dental Alloys For Porcelain Appli. Ref K880348

    Class II
    Active 510(k) 510(k) II

  • Benchmark I Ref K922448

    Class II
    Active 510(k) 510(k) II

  • Legacy-Xt Ref K922451

    Class II
    Active 510(k) 510(k) II

  • Jeltemp Ref K991564

    Class II
    Active 510(k) 510(k) II

  • Eureka Ref K933623

    Class II
    Active 510(k) 510(k) II

  • Freedom Plus (Code Name Misc-Lib-013) Ref K932130

    Class II
    Active 510(k) 510(k) II

  • Hn-40 Ref K923722

    Class II
    Active 510(k) 510(k) II

  • Signum Ref K001360

    Class II
    Active 510(k) 510(k) II

  • Bw-1 (Code Name Rd-0807) Ref K981244

    Class II
    Active 510(k) 510(k) II

  • Symphony Ref K923714

    Class II
    Active 510(k) 510(k) II

  • Mainbond A Ref K984140

    Class II
    Active 510(k) 510(k) II

  • Benchmark C Ref K922450

    Class II
    Active 510(k) 510(k) II

  • Benchmark Iii Ref K922447

    Class II
    Active 510(k) 510(k) II

  • Jel Bios 90 (Code Name Rd-2401) Ref K001196

    Class II
    Active 510(k) 510(k) II

  • Jel 96 Ref K944679

    Class II
    Active 510(k) 510(k) II

  • Jel Bios Pure Ref K002645

    Class II
    Active 510(k) 510(k) II

  • Jel-5 Gold Based Alloys & Precious Metal Alloys Ref K882126

    Class II
    Active 510(k) 510(k) II

  • Jelfine-52 (Code Name Rd-0901) Ref K981257

    Class II
    Active 510(k) 510(k) II

  • Collegiate Ref K922774

    Class II
    Active 510(k) 510(k) II

  • Prospector Plus (Code Name : Rd-0508) Ref K973881

    Class II
    Active 510(k) 510(k) II

  • Jelbond-Pdf Ref K971574

    Class II
    Active 510(k) 510(k) II

  • Suncast Ref K923720

    Class II
    Active 510(k) 510(k) II

  • Prospector Ref K923721

    Class II
    Active 510(k) 510(k) II

  • Microstar Ref K923713

    Class II
    Active 510(k) 510(k) II

  • Ultragold Ref K923817

    Class II
    Active 510(k) 510(k) II

  • Rajah Ref K881354

    Class II
    Active 510(k) 510(k) II

  • Jel Bios 18 (Code Name Rd- 1214) Ref K993152

    Class II
    Active 510(k) 510(k) II

  • Diamond (Code Name Pt-054) Ref K960403

    Class II
    Active 510(k) 510(k) II

  • Eureka Plus Ref K944887

    Class II
    Active 510(k) 510(k) II

  • Allround 4 Ref K944889

    Class II
    Active 510(k) 510(k) II

  • Jel-71 Pdf Ref K971292

    Class II
    Active 510(k) 510(k) II

  • Jel 15 Ref K000532

    Class II
    Active 510(k) 510(k) II

  • Benchmark-Iv Ref K971575

    Class II
    Active 510(k) 510(k) II

  • Suncast D-Kf Ref K923719

    Class II
    Active 510(k) 510(k) II

  • Suncast-D Ref K923715

    Class II
    Active 510(k) 510(k) II

  • Allround 55 Lf Ref K001260

    Class II
    Active 510(k) 510(k) II

  • Jeldent Basic Line Ref K000213

    Class II
    Active 510(k) 510(k) II

  • Jel-0-75 Ref K923716

    Class II
    Active 510(k) 510(k) II

  • Topaz Ref K960399

    Class II
    Active 510(k) 510(k) II

  • Silcast (Code Name Rd-0118) Ref K981247

    Class II
    Active 510(k) 510(k) II

  • Jel-20 Ref K012303

    Class II
    Active 510(k) 510(k) II

  • Olympia Alloy Ref K881333

    Class II
    Active 510(k) 510(k) II

  • Pa-400 Ref K922449

    Class II
    Active 510(k) 510(k) II

  • Medalist Ref K944888

    Class II
    Active 510(k) 510(k) II

  • Freedom Ref K930601

    Class II
    Active 510(k) 510(k) II

  • Accu-Star Ref K922446

    Class II
    Active 510(k) 510(k) II

  • Jelenko NO.1 (Code Name Rd-0601) Ref K970068

    Class II
    Active 510(k) 510(k) II

  • Jelenko Porcelain System Pvs Procelain Ref K923717

    Class II
    Active 510(k) 510(k) II

  • Heraceram Ref K002993

    Class II
    Active 510(k) 510(k) II

Rows 1-50 of 56

Showing 1-50 of 56

Frequently asked questions

How many devices does J.F. Jelenko & Co., Inc. have in the registry?

The registry currently lists 56 devices for J.F. Jelenko & Co., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list J.F. Jelenko & Co., Inc.'s devices?

Among its 50 most recently registered devices, J.F. Jelenko & Co., Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do J.F. Jelenko & Co., Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for J.F. Jelenko & Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from J.F. Jelenko & Co., Inc. in the registry?

The most recently registered devices listed for J.F. Jelenko & Co., Inc. include RD-2104, PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI., BENCHMARK I and LEGACY-XT.

Generated automatically from registry data and not verified by a human reviewer.