RESTORATIVE SYSTEM PROFILE— 510(k) K781293

Substantially Equivalent

The S. S. White Co.

FDA 510(k) clearance K781293 for RESTORATIVE SYSTEM PROFILE, Substantially Equivalent on 1978-08-18. Applicant: The S. S. White Co.. Device class: 2.

Clearance details

Applicant: The S. S. White Co.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1978-07-27
Decision date: 1978-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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 The S. S. White Co.

K852744 — CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR1985-08-16
K852745 — PORCELAIN VENEER SYSTEM BONDING KIT1985-08-16
K853005 — S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM1985-08-13
K852743 — PORCELAIN VENEER SYSTEM LABORATORY KIT1985-07-31
K852182 — EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER1985-07-02

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