CEREC3 VITABLOCKS— 510(k) K012517

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K012517 for CEREC3 VITABLOCKS, Substantially Equivalent on 2001-11-01. Applicant: Sirona Dental Systems GmbH. Device class: 2.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Product code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2001-08-06
Decision date: 2001-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELW

K254142 — Dia-X Sil Heavy Body2026-09-16
K254152 — Dia-X Sil Light Body2026-09-16
K254112 — Dia-X Sil Bite2026-03-19
K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more2025-10-31
K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST2025-06-27

More clearances from Sirona Dental Systems GmbH

K160099 — CEREC SpeedGlaze2016-06-02
K151045 — TENEO Dental Treatment Unit and Accessories2015-07-24
K150909 — INTEGO Family and Accesories2015-07-17
K150750 — Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray2015-07-02
K150217 — ORTHOPHOS SL2015-05-08

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