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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CS 8100 3D; CS 8100 3D Access; CS 8100SC 3D; CS 8100SC 3D Access; CS 8200 3D; CS 8200 3D Access; SCAN CEPH
Classification Name: X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
Product Code: OAS
Device Class: 2
Regulation Number: 892.1750
Medical Specialty: Radiology
Registered Establishment Name: Carestream Dental Technology Topco Limited
Registered Establishment Number: 3014398772
Premarket Submission Number: K133406
Owner/Operator: Carestream Dental LLC
Owner/Operator Number: 10056540
Establishment Operations: Foreign Exporter
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