FDA.reportPublic FDA data

CLARIS

Primary DI
00854810007168
Brand
CLARIS
Company
IcRco, Inc.
Model
CBCT
Catalog number
500-0960-02
Device description
The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120753000CLARISCTIcrco, Inc.2012-07-26OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854810007168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854810007168008548100071688548100071680854810007168

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Regulatory Flags#

DUNS number
610790276
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854810007007AirDRG3900-1596-012026-07-22
00854810007014AirDRLE500-1591-022026-07-22
00854810007045CHROMELF500-0274-022026-07-22
008548100070693600M500-0150-042026-07-22
008548100070763600LF500-0150-012026-07-22
00854810007113iDRL500-0177-122026-07-22
00854810007120iDR34500-0177-1242026-07-22
00854810007199iXRSAirDR G3+INT-XRS-UNI-KIT2026-07-22
00854810007205AirDRG3+900-1596-012026-07-22
008548100072123600SF500-0150-022026-07-22
00854810007229iCRco Clarity Viewer5500-0197-492026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016401936Green X 12 SEVATECH CO., LTD.OAS2026-06-01
08800016401943Green X 12 SEVATECH CO., LTD.OAS2026-06-01
60192155951237CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
E27668234830Primevision 3DSIRONA Dental Systems GmbHOAS2026-04-30
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RAYSCANRay Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24