FDA.reportPublic FDA data

SMARTDent

Primary DI
08800003005017
Brand
SMARTDent
Company
Ray Co., Ltd
Model
3.1.0.0
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251109000SMARTDentRay Co., Ltd.2025-05-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800003005017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800003005017088000030050178800003005017

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690324087
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800003027026RAYSCANScan Ceph2025-12-01
08800003027002RAYSCAN α+, Vision 16, RCT700RCT7002025-08-25
08800003027019RAYSCANScan Ceph (SC)2025-08-25
08800003027033RAYSCANOne Shot Ceph Small2025-08-25
08800003027040RAYSCANOne Shot Ceph Large2025-08-25
08800003027057RAYSCAN STUDIO, Vision 20, RAYPreMiere, RAYSCAN S, Vision 18, RCT800RCT8002025-08-25
08800003027088RAYSCAN α-Expert, RAYSCAN α-PRAYSCAN α-P2025-08-25
08800003027095RAYSCAN α-Expert 3D, RAYSCAN α-3DRAYSCAN α-3D2025-08-25
08800003027064RAYQuantum, RCT600RCT6002025-04-14
08800003027071RAYQuantumScan Ceph2025-04-14
08800003001002RAYSCAN α+RCT7002020-05-08
08800003004003RAYSCAN StudioRCT800 2020-05-08
08800003003013RIOScanRPS500 (STD)2016-10-05
08800003003020RIOScanRPS500 (OCC)2016-10-05
08800003003310RIOScanIP Size 0 2016-10-05
08800003003327RIOScanIP Size 12016-10-05
08800003003334RIOScanIP Size 22016-10-05
08800003003341RIOScanIP Size 32016-10-05
08800003003358RIOScanIP Size 42016-10-05
08800003003365RIOScanIP Size 1, 32016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
00817886020639JointsMEDSTRAT, INC.LLZ2025-03-07
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00817886020622JointsMEDSTRAT, INC.LLZ2025-02-03
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00817886020615JointsMEDSTRAT, INC.LLZ2024-12-09
00817886020608JointsMEDSTRAT, INC.LLZ2024-11-01
00817886020592JointsMEDSTRAT, INC.LLZ2024-08-31
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020585JointsMEDSTRAT, INC.LLZ2024-06-08
00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
00817886020493JointsMEDSTRAT, INC.LLZ2023-03-06
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01
00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17