Carestream Dental L L C

FDA Filings

This page includes the latest FDA filings for Carestream Dental L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1226003
• FEI Number: 3002522649
• Name: Carestream Dental LLC
• Owner & Operator: Carestream Dental LLC
• Contact Address: 3625 Cumberland Boulevard Suite 700; Atlanta GA 30339 US
• Official Correspondent:
  • Raven Wildharber
  • 1-470-4818687-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3625 Cumberland Boulevard Suite 700; Atlanta, GA 30339 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3015219064
• FEI Number: 3015219064
• Name: Carestream Dental Technology Shanghai Co. Ltd.
• Owner & Operator: Carestream Dental LLC
• Contact Address: 3625 Cumberland Boulevard Suite 700; Atlanta GA 30339 US
• Official Correspondent:
  • Raven Wildharber
  • 1-470-4818687-x
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Room 201Building 3, No.1599, Xinjinqiao Road China (Shanghai) Pilot Free Trad; Shanghai Shanghai, 201206 CN
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 8020825
• FEI Number: 7695
• Name: N/A
• Owner & Operator: Carestream Dental LLC
• Contact Address: 3625 Cumberland Boulevard Suite 700; Atlanta GA 30339 US
• Official Correspondent:
  • Raven Wildharber
  • 1-470-4818687-x
• US Agent:
  • N/A
  • N/A
  • 0
  • N/A
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: N/A N/A; N/A, NA N/A US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 60192155945083 CARESTREAM DENTAL LLC	RIOSENSOR+ 5945084	2024-01-25
GUDID 60192155945076 CARESTREAM DENTAL LLC	RIOSensor+ 5945076	2024-01-25
GUDID 60192155944864 CARESTREAM DENTAL LLC	CS 8200 3D Access 5944863	2023-12-20
GUDID 60192155944840 CARESTREAM DENTAL LLC	DENTRA III 5944848	2023-06-12
GUDID 60192155944833 CARESTREAM DENTAL LLC	DENTRA III 5944830	2023-06-12
GUDID 60192155944543 CARESTREAM DENTAL LLC	Swissmeda powered by Carestream Dental 5944541	2022-10-31
GUDID 60192155943720 CARESTREAM DENTAL LLC	CS 3800 Wired 5943725	2022-02-21
GUDID 60192155944482 CARESTREAM DENTAL LLC	CS Model+ 5944483	2021-11-15
GUDID 60192155943065 CARESTREAM DENTAL LLC	CS 3800 Wireless 5943063	2021-01-19
GUDID 60192155943232 CARESTREAM DENTAL LLC	SCAN CEPH 5943238	2020-06-30
GUDID 60192155943218 CARESTREAM DENTAL LLC	CS 8200 3D 5943212	2020-06-30
GUDID 60192155942716 CARESTREAM DENTAL LLC	CS Model+ 5942719	2020-05-05
GUDID 60192156577894 CARESTREAM DENTAL LLC	CS 3600 6577894	2020-04-27
PMN K200183 | OAS N/A [Carestream Dental LLC]	Trophypan Supreme 3D	2020-04-13
PMN K200183 | OAS N/A [Carestream Dental LLC]	Scan Ceph	2020-04-13
PMN K200183 | OAS N/A [Carestream Dental LLC]	CS 9600	2020-04-13
PMN K193390 | PNN N/A [Carestream Dental LLC]	CS Model+	2020-04-03
GUDID 60192155942655 CARESTREAM DENTAL LLC	CS 7600 Hygienic Sheath 5942651	2020-03-24
GUDID 60192155942648 CARESTREAM DENTAL LLC	CS 7600 Hygienic Sheath 5942644	2020-03-24
GUDID 60192155942631 CARESTREAM DENTAL LLC	CS 7600 Hygienic Sheath 5942636	2020-03-24
GUDID 60192155942624 CARESTREAM DENTAL LLC	CS 7600 Hygienic Sheath 5942628	2020-03-24
GUDID 60192155942617 CARESTREAM DENTAL LLC	CS 7600 Hygienic Sheath 5942610	2020-03-24
GUDID 60192155943010 CARESTREAM DENTAL LLC	CS Imaging Suite 5943014	2020-03-20
GUDID 60192155942563 CARESTREAM DENTAL LLC	CS 7600 Smart Plate 5942560	2020-02-25
GUDID 60192155942556 CARESTREAM DENTAL LLC	CS 7600 Smart Plate 5942552	2020-02-25
GUDID 60192155942549 CARESTREAM DENTAL LLC	CS 7600 Smart Plate 5942545	2020-02-25
GUDID 60192155942532 CARESTREAM DENTAL LLC	CS 7600 Smart Plate 5942537	2020-02-25
GUDID 60192155942518 CARESTREAM DENTAL LLC	CS 7600 Smart Plate 5942511	2020-02-25
GUDID 60192155942396 CARESTREAM DENTAL LLC	SCAN CEPH 5942396	2020-02-25
GUDID 60192155319556 CARESTREAM DENTAL LLC	Trophy 3D Imaging 5319553	2020-02-25
GUDID 60192155942587 CARESTREAM DENTAL LLC	Imaging Plate 5942586	2020-02-21
GUDID 60192155313950 CARESTREAM DENTAL LLC	RVG CONNECT 5313952	2020-02-17
GUDID 60192156851635 CARESTREAM DENTAL LLC	CS Orthodontic Imaging Software 1043272	2020-02-10
GUDID 60192156577153 CARESTREAM DENTAL LLC	CS 3600 6577159	2020-02-10
GUDID 60192156560070 CARESTREAM DENTAL LLC	CS 1200 6560072	2020-02-10
GUDID 60192156559999 CARESTREAM DENTAL LLC	CS 1200 6559991	2020-02-10
GUDID 60192156559852 CARESTREAM DENTAL LLC	CS 1500 6559850	2020-02-10
GUDID 60192156559814 CARESTREAM DENTAL LLC	CS 1500 6559819	2020-02-10
GUDID 60192155950032 CARESTREAM DENTAL LLC	CS 3600 CPAE7600	2020-02-10
GUDID 60192155942723 CARESTREAM DENTAL LLC	CS 7200 5942727	2020-02-10
GUDID 60192155942341 CARESTREAM DENTAL LLC	CS 3600 5942347	2020-02-10
GUDID 60192155942143 CARESTREAM DENTAL LLC	CS 3600 5942149	2020-02-10
GUDID 60192155313998 CARESTREAM DENTAL LLC	RVG 6200 5313994	2020-02-10
GUDID 60192155310720 CARESTREAM DENTAL LLC	RVG 6200 5310727	2020-02-10
GUDID 60192155310713 CARESTREAM DENTAL LLC	RVG 6200 5310719	2020-02-10
GUDID 60192155155116 CARESTREAM DENTAL LLC	RVG 6100 5155114	2020-02-10
GUDID 60192155154256 CARESTREAM DENTAL LLC	CG799 5154257	2020-02-10
GUDID 60192155154249 CARESTREAM DENTAL LLC	CG798 5154240	2020-02-10
GUDID 60192155942730 CARESTREAM DENTAL LLC	CS 7600 5942735	2019-12-23
GUDID 60192155942600 CARESTREAM DENTAL LLC	Imaging Plate 5942602	2019-12-23
GUDID 60192155942594 CARESTREAM DENTAL LLC	Imaging Plate 5942594	2019-12-23
GUDID 60192155942570 CARESTREAM DENTAL LLC	Hygienic Sheath 5942578	2019-12-23
GUDID 60192155942525 CARESTREAM DENTAL LLC	Hygienic Sheath 5942529	2019-12-23
GUDID 60192155942501 CARESTREAM DENTAL LLC	Hygienic Sheath 5942503	2019-12-23
GUDID 60192155942754 CARESTREAM DENTAL LLC	Logicon Caries Detector 5942750	2019-12-20
GUDID 60192155319730 CARESTREAM DENTAL LLC	CS 9300C 5319736	2019-12-10
GUDID 60192155319693 CARESTREAM DENTAL LLC	CS 9300C 5319694	2019-12-10
GUDID 60192155942662 CARESTREAM DENTAL LLC	CS 3700 5942669	2019-11-13
GUDID 60192155941306 CARESTREAM DENTAL LLC	CS 3700 5941307	2019-11-13
GUDID 60192156851628 CARESTREAM DENTAL LLC	Logicon Caries Detector 8008690	2019-11-01
GUDID 60192155942136 CARESTREAM DENTAL LLC	CS 8100SC 3D 5942131	2019-10-28
GUDID 60192155942129 CARESTREAM DENTAL LLC	CS 8100 3D 5942123	2019-10-28
GUDID 60192155501197 CARESTREAM DENTAL LLC	CS 9600 5501192	2019-10-28
GUDID 60192155500237 CARESTREAM DENTAL LLC	CS 8100SC 3D Access 5500236	2019-10-28
GUDID 60192155500114 CARESTREAM DENTAL LLC	CS 8100SC 3D 5500111	2019-10-28
GUDID 60192155319716 CARESTREAM DENTAL LLC	CS 9300 Select 5319710	2019-10-28
GUDID 60192155319686 CARESTREAM DENTAL LLC	CS 9300 5319686	2019-10-28
PMA P980025S004 CARESTREAM DENTAL LLC	Logicon Caries Detection Software	2019-09-05
GUDID 60192155501548 CARESTREAM DENTAL LLC	Trophypan Supreme 3D 5501549	2019-06-07
GUDID 60192155500688 CARESTREAM DENTAL LLC	Trophy Imaging 8 5500681	2019-06-07
GUDID 60192155303067 CARESTREAM DENTAL LLC	CS 8100 5303060	2019-06-07
GUDID 60192155303043 CARESTREAM DENTAL LLC	CS 8100 5303045	2019-06-07
GUDID 60192155302893 CARESTREAM DENTAL LLC	SINGLE USE SLEEVES - EAR RODS 5302898	2019-06-07
GUDID 60192155302886 CARESTREAM DENTAL LLC	SINGLE USE SLEEVES - 3D BITE BLOCK 5302880	2019-06-07
GUDID 60192155302879 CARESTREAM DENTAL LLC	SINGLE USE SLEEVES - PANO BITE BLOCK 5302872	2019-06-07
GUDID 60192155211010 CARESTREAM DENTAL LLC	CEPHALOSTAT 5211016	2019-06-07
GUDID 60192155153617 CARESTREAM DENTAL LLC	CS 2200 5153614	2019-06-07
GUDID 60192155153600 CARESTREAM DENTAL LLC	CS 2200 5153606	2019-06-07
GUDID 60192155153594 CARESTREAM DENTAL LLC	CS 2200 5153598	2019-06-07
GUDID 60192155153587 CARESTREAM DENTAL LLC	CS 2200 5153580	2019-06-07
GUDID 60192155153570 CARESTREAM DENTAL LLC	CS 2200 5153572	2019-06-07
GUDID 60192155153563 CARESTREAM DENTAL LLC	CS 2200 5153564	2019-06-07
GUDID 60192155008191 CARESTREAM DENTAL LLC	Hygienic Sleeves Ear Cones BDA17	2019-06-07
GUDID 60192155008184 CARESTREAM DENTAL LLC	Hygienic Sleeves 3D Bite Block BDA16	2019-06-07
GUDID 60192155008177 CARESTREAM DENTAL LLC	Hygienic Sleeves Bite Block BDA15	2019-06-07
GUDID 60192155008160 CARESTREAM DENTAL LLC	RVG 5100 CIC52	2019-06-07
GUDID 60192155008153 CARESTREAM DENTAL LLC	RVG 6100 CIC51	2019-06-07
GUDID 60192155008108 CARESTREAM DENTAL LLC	RVG 5200 CIC48	2019-06-07
GUDID 60192155008092 CARESTREAM DENTAL LLC	RVG 5200 CIC47	2019-06-07
GUDID 60192155008085 CARESTREAM DENTAL LLC	RVG 6200 CIC46	2019-06-07
GUDID 60192155008078 CARESTREAM DENTAL LLC	RVG 6200 CIC45	2019-06-07
GUDID 60192155008061 CARESTREAM DENTAL LLC	RVG 6500 CIC44	2019-06-07
GUDID 60192155008054 CARESTREAM DENTAL LLC	RVG 6500 CIC43	2019-06-07
GUDID 60192155008047 CARESTREAM DENTAL LLC	RVG 6500 CIC42	2019-06-07
GUDID 60192155008030 CARESTREAM DENTAL LLC	RVG 6100 CIC41	2019-06-07
GUDID 60192155008023 CARESTREAM DENTAL LLC	RVG 6100 CIC40	2019-06-07
GUDID 60192155008016 CARESTREAM DENTAL LLC	RVG 5100 CIC39	2019-06-07
GUDID 60192151068403 CARESTREAM DENTAL LLC	CS 7600 1068402	2019-06-07
GUDID 60192151067475 CARESTREAM DENTAL LLC	CS 7200 1067479	2019-06-07
GUDID 60192151044445 CARESTREAM DENTAL LLC	CS 7600 SLOT PANEL 1023704	2019-06-07
GUDID 60192151023716 CARESTREAM DENTAL LLC	CS 7600 SLOT PANEL 1023704	2019-06-07
GUDID 60192151023709 CARESTREAM DENTAL LLC	CS 7600 SLOT PANEL 1023704	2019-06-07
GUDID 60192151018903 CARESTREAM DENTAL LLC	CS 7600 1018902	2019-06-07
GUDID 60192151014318 CARESTREAM DENTAL LLC	CS 7600 1014315	2019-06-07
GUDID 60192151014301 CARESTREAM DENTAL LLC	CS 7600 1014307	2019-06-07
PMN K111649 | MUH Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 7600	2019-02-13
PMN K111649 | MUH Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 7600 SLOT PANEL	2019-02-13
PMN K111649 | MUH Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 7600 SCAN&GO DEVICE	2019-02-13
PMN K111649 | MUH Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 7200	2019-02-13
PMN K111649 | MUH Carestream Dental LLC	CS 7600	2019-02-13
PMN K111649 | MUH Carestream Dental LLC	CS 7600 SLOT PANEL	2019-02-13
PMN K111649 | MUH Carestream Dental LLC	CS 7600 SCAN&GO DEVICE	2019-02-13
PMN K111649 | MUH Carestream Dental LLC	CS 7200	2019-02-13
PMN K091186 | EIA Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 1500	2019-02-13
PMN K091186 | EIA Carestream Dental LLC	CS 1500	2019-02-13
NOF Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	Trophy 3DI Pro	2019-02-13
NOF Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	Trophy 3DI Beyond	2019-02-13
NOF Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 3700	2019-02-13
NOF Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 3600	2019-02-13
NOF Carestream Dental LLC	Trophy 3DI Pro	2019-02-13
NOF Carestream Dental LLC	Trophy 3DI Beyond	2019-02-13
NOF Carestream Dental LLC	CS 3700	2019-02-13
NOF Carestream Dental LLC	CS 3600	2019-02-13
EAM Carestream Dental LLC	Imaging Plate	2019-02-13
EAM Carestream Dental LLC	CS 7600	2019-02-13
EAM Carestream Dental LLC	CS 7600 Smart Plate	2019-02-13
EAM Carestream Dental LLC	CS 7200	2019-02-13
PMN K112321 | EIA Carestream Dental Technology Shanghai Co. Ltd. [Carestream Dental LLC]	CS 1200	2019-02-12
PMN K112321 | EIA Carestream Dental LLC	CS 1200	2019-02-12
PMN K181136 | OAS N/A [Carestream Dental LLC]	CS 9600	2018-05-29
PMN K173622 | LLZ N/A [Carestream Dental LLC]	CS Imaging (Version 8)	2018-01-17
PMN P980025 | MYN Carestream Dental LLC	Logicon Caries Detector	2017-12-20
PMN K950532 | EAP N/A [Carestream Dental LLC]	RVG CONNECT	2017-12-20
PMN K950532 | EAP N/A [Carestream Dental LLC]	RVG 6200	2017-12-20
PMN K950532 | EAP N/A [Carestream Dental LLC]	RVG 6100	2017-12-20
PMN K950532 | EAP N/A [Carestream Dental LLC]	RVG 5200	2017-12-20
PMN K950532 | EAP N/A [Carestream Dental LLC]	RVG 5100	2017-12-20
PMN K151837 | LLZ N/A [Carestream Dental LLC]	CS 3D Imaging Software	2017-12-20
PMN K151087 | MUH N/A [Carestream Dental LLC]	CS 8100SC	2017-12-20
PMN K151087 | MUH N/A [Carestream Dental LLC]	CS 8100SC Access	2017-12-20
PMN K141607 | LLZ N/A [Carestream Dental LLC]	Dental Imaging Software	2017-12-20
PMN K141607 | LLZ N/A [Carestream Dental LLC]	CS Imaging (version 7)	2017-12-20
PMN K133406 | OAS N/A [Carestream Dental LLC]	SCAN CEPH	2017-12-20
PMN K133406 | OAS N/A [Carestream Dental LLC]	CS 8100SC 3D	2017-12-20
PMN K133406 | OAS N/A [Carestream Dental LLC]	CS 8100SC 3D Access	2017-12-20
PMN K133406 | OAS N/A [Carestream Dental LLC]	CS 8100 3D	2017-12-20
PMN K133406 | OAS N/A [Carestream Dental LLC]	CS 8100 3D Access	2017-12-20
PMN K133406 | MUH N/A [Carestream Dental LLC]	SCAN CEPH	2017-12-20
PMN K133406 | MUH N/A [Carestream Dental LLC]	CS 8100SC 3D	2017-12-20
PMN K133406 | MUH N/A [Carestream Dental LLC]	CS 8100SC 3D Access	2017-12-20
PMN K133406 | MUH N/A [Carestream Dental LLC]	CS 8100 3D	2017-12-20
PMN K133406 | MUH N/A [Carestream Dental LLC]	CS 8100 3D Access	2017-12-20
PMN K122427 | LLZ Carestream Dental LLC	CS Orthodontic	2017-12-20
PMN K122427 | LLZ Carestream Dental LLC	CS OMS Imaging software	2017-12-20
PMN K120975 | MUH N/A [Carestream Dental LLC]	CS 8100	2017-12-20
PMN K120975 | MUH N/A [Carestream Dental LLC]	CS 8100 Access	2017-12-20
PMN K103659 | OAS N/A [Carestream Dental LLC]	CS 9300C	2017-12-20
PMN K103659 | OAS N/A [Carestream Dental LLC]	CS 9300C Select	2017-12-20
PMN K103659 | OAS N/A [Carestream Dental LLC]	CS 9300	2017-12-20
PMN K103659 | OAS N/A [Carestream Dental LLC]	CS 9300 Select	2017-12-20
PMN K103659 | OAS N/A [Carestream Dental LLC]	CEPHALOSTAT	2017-12-20
PMN K093478 | MUH N/A [Carestream Dental LLC]	RVG CONNECT (for US)	2017-12-20
PMN K093478 | MUH N/A [Carestream Dental LLC]	RVG 6500	2017-12-20
PMN K082972 | MUH N/A [Carestream Dental LLC]	9500 CONE BEAM 3D SYSTEM	2017-12-20
PMN K080889 | MUH N/A [Carestream Dental LLC]	CS 9000C	2017-12-20
PMN K080889 | MUH N/A [Carestream Dental LLC]	CEPHALOSTAT	2017-12-20
PMN K073435 | MUH N/A [Carestream Dental LLC]	CS 9000C 3D	2017-12-20
PMN K073435 | MUH N/A [Carestream Dental LLC]	CS 9000	2017-12-20
PMN K073435 | MUH N/A [Carestream Dental LLC]	CS 9000 3D	2017-12-20
PMN K060292 | EHD N/A [Carestream Dental LLC]	CS 2200	2017-12-20
PMN K060292 | EHD N/A [Carestream Dental LLC]	CS 2100	2017-12-20
PMN K060292 | EHD N/A [Carestream Dental LLC]	CG797	2017-12-20
KQM Carestream Dental LLC	Hygienic Sleeves Ear Cones	2017-12-20
KQM Carestream Dental LLC	Hygienic Sleeves Bite Block	2017-12-20
KQM Carestream Dental LLC	Hygienic Sleeves 3D Bite Block	2017-12-20
KQM Carestream Dental LLC	Hygienic Sheath	2017-12-20
KQM Carestream Dental LLC	CS 7600 Hygienic Sheath	2017-12-20
PMA P980025S003 CARESTREAM DENTAL LLC	LOGICON CARIES DETECTOR	2015-12-10
PMA P980025S002 CARESTREAM DENTAL LLC	LOGICON CARIES DETECTOR	2014-07-22
PMN K122427 CARESTREAM DENTAL LLC	CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE	2012-09-12
PMA P980025S001 CARESTREAM DENTAL LLC	LOGICON CARIES DETECTOR	2007-01-12
PMA P980025 CARESTREAM DENTAL LLC	LOGICON CARIES DETECTOR	1998-09-25

Related Finance Registrations

NCAGE Code	47R32	CARESTREAM DENTAL LLC!DBA CS DENTAL
CAGE Code	47R32	CARESTREAM DENTAL LLC CS DENTAL
S.A.M. Registration	47R32 [19796106]	CARESTREAM DENTAL LLC CS DENTAL
DUNS	019796106	Carestream Dental LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018072465670	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	86 CTN
2018072465670	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	86 CTN
2018071758667	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	38 CTN
2018071780639	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	42 CTN
2018070422594	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHTOGRAPHIC DENTAL MATERIAL	27 CTN
2018070371153	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	45 CTN
2018061981328	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHTOGRAPHIC DENTAL MATERIAL	27 CTN
2018061263397	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	38 CTN
2018060568723	Le Havre,France -> New York/Newark Area, Newark, New Jersey	PHOTOGRAPHIC DENTAL MATERIAL	33 CTN