O-TRAY IMPRESSION TRAYS— 510(k) K942668

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K942668 for O-TRAY IMPRESSION TRAYS, Substantially Equivalent on 1994-07-22. Applicant: Dentauraum, Inc.. Device class: 1.

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code EHY
Device class: Class 1
Regulation: 21 CFR 872.6880
Advisory panel: Dental
Date received: 1994-06-06
Decision date: 1994-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EHY

K896470 — EOS IMPRESSION TRAYS1990-02-09
K884316 — OCCLUSAL HARMONY IMPRESSION TRAY1988-12-22
K863836 — POST TRAY1986-10-14
K850776 — PREFORMED DENTAL IMPRESSION TRAYS1985-03-18
K842273 — CROWN INDEX TRAY1984-07-31

More clearances from Dentauraum, Inc.

K952866 — REMATITAN TITANIUM1995-07-27
K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH1995-07-27
K952870 — REMANIUM: CS & G-SOFT1995-07-27
K952865 — REMANIUM: 200,CS, 380, AND CD1995-07-26
K952868 — DENTAURUM JACKET CROWN & ROOT POSTS1995-07-19

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