ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE— 510(k) K802975

Name: FDA 510(k) clearance K802975
Creator: U.S. Food and Drug Administration
Published: 1981-01-14

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K802975 for ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE, Substantially Equivalent on 1981-01-14. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1980-11-21
Decision date: 1981-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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 Dentsply Intl.

view all

K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC2013-02-22
K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2008-03-27
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2007-03-14
K070019 — CARRARA VOLUMIA2007-01-26
K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

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