STERN'S S250 NORDAM— 510(k) K092917

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K092917 for STERN'S S250 NORDAM, Substantially Equivalent on 2010-06-24. Applicant: Cefla S.C.. Device class: 1.

Clearance details

Applicant: Cefla S.C.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2009-09-22
Decision date: 2010-06-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ormond Beach, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K243130 — Integral Dental Unit2025-06-27
K242611 — Integral Dental Units2025-05-27

More clearances from Cefla S.C.

K260716 — Neowise2026-05-04
K252353 — myray ProXIma X62026-03-10
K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,2024-04-01
K231990 — Apex Locator2024-02-13
K223794 — hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS2023-01-17

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