APOLLO 95E— 510(k) K981948

Name: FDA 510(k) clearance K981948
Creator: U.S. Food and Drug Administration
Published: 1998-08-18

Substantially Equivalent

Dental/Medical Diagnostic Systems, Inc.

FDA 510(k) clearance K981948 for APOLLO 95E, Substantially Equivalent on 1998-08-18. Applicant: Dental/Medical Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Dental/Medical Diagnostic Systems, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1998-06-03
Decision date: 1998-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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 Dental/Medical Diagnostic Systems, Inc.

view all

K990087 — DMD DIGITAL X-RAY SYSTEM1999-05-13
K980474 — TELICAM1998-04-13

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