NEW PER-FIT(R) IMPROVED— 510(k) K901621

Name: FDA 510(k) clearance K901621
Creator: U.S. Food and Drug Administration
Published: 1990-06-26

Substantially Equivalent

Dental Product Co.

FDA 510(k) clearance K901621 for NEW PER-FIT(R) IMPROVED, Substantially Equivalent on 1990-06-26. Applicant: Dental Product Co.. Device class: 2.

Clearance details

Applicant: Dental Product Co.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1990-04-05
Decision date: 1990-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hammett, ID, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBI

view all

K261802 — Glidewell Denture Base Resin2026-08-27
K261626 — UltraPrint Flexible Denture UV2026-08-13
K262681 — NanoCeram Resin2026-07-31
K262300 — Denture Base Resin V22026-07-08
K261474 — DENTCA Tru Flexible2026-07-01

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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