510(k) clearances

DS Core CBCT Anatomy

Dentsply Sirona · Radiology

K262127Substantially EquivalentTraditionalQIH
Open FDA's page for this record
Third party flag
N
City
York
Advisory committee description
Radiology
Address 1
221 W. Philadelphia St.
Statement or summary
Summary
Product code
QIH
Zip code
17401
Applicant
Dentsply Sirona
Decision date
2026-08-21
Decision code
SESE
Country code
US
Device name
DS Core CBCT Anatomy
Advisory committee
RA
Contact
Deepthi Paknikar
K number
K262127
State
PA
Date received
2026-06-24
Review advisory committee
RA
Postal code
17401
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Automated Radiological Image Processing Software
Medical specialty description
Radiology
Regulation number
892.2050
Device class
2
Registration number
8043836, 3019844085, 3016461002, 8022257, 3013410552, 3019541896, 3033527283, 3008693672, 3013552417, 3017210169, 3003594449, 1000432246, 9710090, 3020928588, 9616047, 3040335643, 3015516266, 9617277, 3030655434, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3007630531, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 9616251, 2936485 +197 more
FEI number
3019844085, 3016461002, 3013410552, 3019541896, 3002807692, 3003309342, 3033527283, 3008693672, 3002087856, 3010289997, 3013552417, 3003594449, 3017210169, 1000432246, 3002807880, 3020928588, 3040335643, 3015516266, 3030655434, 3007630531, 3010952312, 3001722928, 3015612252, 3042243683, 3038177848, 3042902406, 3003190524, 3033508292, 3019216, 3015425142, 3017167291, 3012981490, 3010885402, 3029915548, 3017426576, 3045078825, 3014146081, 3025110425, 3042248552, 2936485 +197 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.