Data / Medical devices / United States / Carestream Dental LLC

Carestream Dental LLC: FDA-registered device maker in Atlanta, GA, United States, 14 510(k) clearances and 1 PMA approval

Name: Carestream Dental LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carestream Dental LLC is registered with the FDA (registration 1226003) in Atlanta, GA, United States. It lists 10 device types. The FDA files 14 510(k) clearances and 1 PMA approval under its listings, the newest dated March 13, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1226003
FEI number: 3002522649
Address: 3625 Cumberland Boulevard Suite 700, Atlanta, GA, United States, 30339
Owner or operator: Carestream Dental LLC (10056540)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 20, 2017
Registered through: 2026
Brand names listed: 7600 Hygienic Sheaths size 0, 7600 Hygienic Sheaths size 1, 7600 Hygienic Sheaths size 2, 7600 Hygienic Sheaths size 3, 7600 Hygienic Sheaths size 4, CEPHALOSTAT, CG913, CGH99 and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Medical Image	MYN	2	Complaint file establishment	accessdata.fda.gov
Film, Radiographic	IWZ	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Complaint file establishment	accessdata.fda.gov
Screen, Intensifying, Radiographic	EAM	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Complaint file establishment	accessdata.fda.gov
Unit, X-Ray, Intraoral	EAP	2	Complaint file establishment	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 13, 2020	K200183	CS 9600	OAS	Substantially Equivalent	Trophy	accessdata.fda.gov
May 24, 2018	K181136	CS 9600	OAS	Substantially Equivalent	Trophy	accessdata.fda.gov
January 16, 2018	K173622	CS Imaging	LLZ	Substantially Equivalent	Trophy	accessdata.fda.gov
March 14, 2014	K133406	CS 8100 3D	OAS	Substantially Equivalent	Trophy	accessdata.fda.gov
September 12, 2012	K122427	CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE	LLZ	Substantially Equivalent	Carestream Dental, LLC	accessdata.fda.gov
June 22, 2012	K120975	CS 8100 CS 8100 ACCESS	MUH	Substantially Equivalent	Trophy	accessdata.fda.gov
January 25, 2012	K112251	SWISSMEDA DENTAL PLANNING SYSTEM	LLZ	Substantially Equivalent	Swissmeda AG	accessdata.fda.gov
November 10, 2011	K112321	CS 1200	EIA	Substantially Equivalent	Carestream Health, Inc.	accessdata.fda.gov
September 23, 2011	K111649	CS 7600	MUH	Substantially Equivalent	Carestream Health, Inc.	accessdata.fda.gov
August 18, 2011	K103659	CS 9300, CS 9300C	OAS	Substantially Equivalent	Trophy	accessdata.fda.gov
April 26, 2010	K093478	KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM	MUH	Substantially Equivalent	Trophy	accessdata.fda.gov
August 18, 2009	K091186	KODAK 1500 INTRAORAL CAMERA	EIA	Substantially Equivalent	Carestream Health, Inc.	accessdata.fda.gov
March 3, 2006	K060292	KODAK MODELS 2100 AND 2200	EHD	Substantially Equivalent	Kodak-Trophy	accessdata.fda.gov
April 19, 1995	K950532	TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY	EAP	Substantially Equivalent	Trophy Radiologie	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 25, 1998	P980025	LOGICON CARIES DETECTOR	MYN	4	September 5, 2019	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 15, 2021	87443	Class II	Terminated	Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.	The mirror may become detached and fall from the unit	accessdata.fda.gov

Compare with other makers

Updated March 13, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.