Facility

Trophy

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	7695
Establishment type	Manufacture Medical Device
Location	4 rue F. Pelloutier Marne La Vallee Ile-de-France, FR 77435
Registration status	Active · expires 2026
Parent company	Carestream Dental LLC (owner-operator 10056540)
Brand names	SCAN CEPH; CS 8100 3D; CS 8100SC 3D Access; CS 8100SC 3D; CS 8100 3D Access; CS 8200 3D Access; CS 8200 3D

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (2)

System, X-Ray, Extraoral Source, Digital
Product code MUH (opens in a new tab) · Class II · Dental · 21 CFR 872.1800
X-Ray, Tomography, Computed, Dental
Product code OAS (opens in a new tab) · Class II · Radiology · 21 CFR 892.1750

Recalls & enforcement

Class IITerminated2021-02-15
The mirror may become detached and fall from the unit

FDA inspections (2)

NAI2026-01-15
No Action Indicated · Compliance: Devices
VAI2023-03-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Trophy (FEI 7695) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/7695-trophy/

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