Facility

Carestream Dental Technology Topco Limited

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3014398772
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	C/O Corporation Service Company (Uk) Limited London London, City of, GB E14 5HU
Registration status	Active · expires 2026
Parent company	Carestream Dental LLC (owner-operator 10056540)
Brand names	CS 8100 Access; CS 8100

Activity by year

Recalls (1)

Devices registered here (1)

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

Recalls & enforcement

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

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. “Carestream Dental Technology Topco Limited (FEI 3014398772) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014398772-carestream-dental-technology-topco-limit/

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