CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO— 510(k) K932826

Name: FDA 510(k) clearance K932826
Creator: U.S. Food and Drug Administration
Published: 1994-01-28

Substantially Equivalent

Alpha-Dent

FDA 510(k) clearance K932826 for CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO, Substantially Equivalent on 1994-01-28. Applicant: Alpha-Dent. Device class: 2.

Clearance details

Applicant: Alpha-Dent
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1993-06-09
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Alpha-Dent

view all

K932828 — CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE1994-02-03
K932829 — CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST1994-01-28
K932827 — ALPHA-DENT CORE BUILDUP PASTE1993-09-23
K904813 — VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.1991-05-31
K904812 — COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE1991-02-26

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