FDA Device Intelligence
HomeSURE DENT CORPORATION › Edge .04 PP

Edge .04 PP

SURE DENT CORPORATION · Model SPP4504-1 · UDI-DI 08800069209558

EKN Prescription
7
510(k) clearances
0
Adverse events
5
Recalls
86
Facilities

Description

Edge 04 Paper Points 45.04

Recalls

DateFirmReason
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
2017-08-04Ultradent Products, Inc.The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.