COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE— 510(k) K904812

Name: FDA 510(k) clearance K904812
Creator: U.S. Food and Drug Administration
Published: 1991-02-26

Substantially Equivalent

Alpha-Dent

FDA 510(k) clearance K904812 for COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE, Substantially Equivalent on 1991-02-26. 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: 1990-10-25
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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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

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K932828 — CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE1994-02-03
K932826 — CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO1994-01-28
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

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