Trophy

Reg #: 8020825 · FEI: 7695 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: Trophy
Registration Number: 8020825
FEI Number: 7695
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 4 rue F. Pelloutier, CROISSY- BEAUBOURG
City: Marne La Vallee Ile-de-France
Country: FR

Regulatory Submissions

510(k) Number: K950532
PMA Number: P980025

Owner / Operator

Firm Name: Carestream Dental LLC
Operator Number: 10056540
Address: 3625 Cumberland Boulevard, Suite 700
City: Atlanta
State: GA
Postal Code: 30339
Country: US
Correspondent: Raven Wildharber

US Agent

Business Name: Carestream Dental LLC
Contact Name: Raven Wildharber
Address: 3625 Cumberland Boulevard, Suite 700
City: Atlanta
State: GA
ZIP: 30339
Country: US
Email: [email protected]
Phone: 470 4818687

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Unit, X-Ray, Intraoral	EAP	Class 2	Dental	No	2017-12-20
System, Image Processing, Radiological	LLZ	Class 2	Radiology	No	2017-12-20
Camera, Surgical And Accessories	KQM	Class 1	General, Plastic Surgery	No	2017-12-20
System, X-Ray, Extraoral Source, Digital	MUH	Class 2	Dental	No	2017-12-20
X-Ray, Tomography, Computed, Dental	OAS	Class 2	Radiology	No	2017-12-20
Analyzer, Medical Image	MYN	Class 2	Radiology	No	2017-12-20
Unit, X-Ray, Extraoral With Timer	EHD	Class 2	Dental	No	2017-12-20

Proprietary Names

RVG 6200 RVG 5200 RVG 142 RIOSensor+ S2 DENTRA III CS 3D Imaging Software Hygienic Sleeves Ear Cones Hygienic Sleeves 3D Bite Block Hygienic Sleeves Bite Block CS 1300 CS 8100 Access CS 8100 CS 9300 CEPHALOSTAT CS 9300 Select CS 9300C CS 9300C Select Logicon Caries Detector CS Imaging (Version 8) CS 8100SC Access CS 8100SC RVG CONNECT RVG 6500 CS 9600 CS 2100 CS 2200 CS 8100SC 3D Access CS 8100 3D Access CS 8100SC 3D CS 8100 3D SCAN CEPH CS 8200 3D Access CS 8200 3D Scan Ceph

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device