Signum

FDA 510(k) K001360 · J.F. Jelenko & Co., Inc.

Substantially Equivalent

510(k) numberK001360

Submission

Device name
Signum
Applicant
J.F. Jelenko & Co., Inc.
Armonk, NY, US
Received
April 28, 2000
Decision date
June 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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K261093DiafilEBF · Traditional DiaDent Group International06/02/2026SE
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional DiaDent Group International05/19/2026SE
K260805Dual CoreEBF · Traditional Vericom Co., Ltd.05/11/2026SE
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K261356Dura-CrownEBF · Special Hangzhou SHINING3D Dental Technology Co., Ltd.04/27/2026SE

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K002222RD-2104EJT · Traditional 08/31/2000SE
K001260Allround 55 LFEJT · Traditional 05/17/2000SE
K001196Jel Bios 90 (Code Name RD-2401)EJT · Traditional 05/11/2000SE
K000532Jel 15EJS · Traditional 04/06/2000SE
K000213Jeldent Basic LineELM · Traditional 04/06/2000SE
K993152Jel Bios 18 (Code Name Rd- 1214)EJT · Traditional 10/21/1999SE
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Questions and answers

When was Signum cleared by the FDA?

Signum (K001360) received a 510(k) decision of Substantially Equivalent on June 20, 2000, 53 days after the submission was received.

What is the product code of K001360?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.