FDA.reportPublic FDA data

Yomi S Intra Oral Fiducial Array Large

Primary DI
00810004900677
Brand
Yomi S Intra Oral Fiducial Array Large
Company
NEOCIS INC
Model
DRW-2823-03
Device description
Yomi S Intra Oral Fiducial Array Large
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PLVDental Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLVDental Stereotaxic InstrumentDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252376000Yomi S Robotic SystemNeocis, Inc.2025-10-28PLV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004900677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004900677008100049006778100049006770810004900677

GMDN Terms#

Term, Definition table
TermDefinition
Dental stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during dental surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
802312434
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004900851O Rings for Yomi S TEE Screw Bag of 25DRW-3848-002026-06-03
00810004900639Yomi S Extra Oral Fiducial Array LLURDRW-2824-012025-12-01
00810004900646Yomi S Extra Oral Fiducial Array LRULDRW-2824-022025-12-01
00810004900653Yomi S Intra Oral Fiducial Array SmallDRW-2823-012025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumDRW-2823-022025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURDRW-2773-012025-12-01
00810004900691Yomi S YomiLink Teeth Posterior LRULDRW-2773-022025-12-01
00810004900707Yomi S YomiLink Arch LLURDRW-2774-012025-12-01
00810004900714Yomi S YomiLink Arch LRULDRW-2774-022025-12-01
00810004900721Yomi S YomiLink Teeth Anterior LLURDRW-2775-012025-12-01
00810004900738Yomi S YomiLink Teeth Anterior LRULDRW-2775-022025-12-01
00810004900745Yomi S YomiLink Bone Lower LLDRW-2771-012025-12-01
00810004900752Yomi S YomiLink Bone Lower LRDRW-2771-022025-12-01
00810004900769Yomi S YomiLink Bone Upper ULDRW-2772-012025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)DRW-2772-022025-12-01
00810004900783Yomi S Tracker End Effector AssemblyDRW-2839-002025-12-01
00810004900790Yomi S YomiLink-TEE ScrewDRW-2682-002025-12-01
00810004900806Yomi S TEE Flange ScrewDRW-2683-002025-12-01
00810004900813Yomi S Fiducial Array ScrewDRW-2688-002025-12-01
00810004900820Yomi S Draping KitDRW-3638-002025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810004900851O Rings for Yomi S TEE Screw Bag of 25NEOCIS INCPLV2026-06-03
00810004900639Yomi S Extra Oral Fiducial Array LLURNEOCIS INCPLV2025-12-01
00810004900646Yomi S Extra Oral Fiducial Array LRULNEOCIS INCPLV2025-12-01
00810004900653Yomi S Intra Oral Fiducial Array SmallNEOCIS INCPLV2025-12-01
00810004900660Yomi S Intra Oral Fiducial Array MediumNEOCIS INCPLV2025-12-01
00810004900684Yomi S YomiLink Teeth Posterior LLURNEOCIS INCPLV2025-12-01
00810004900691Yomi S YomiLink Teeth Posterior LRULNEOCIS INCPLV2025-12-01
00810004900707Yomi S YomiLink Arch LLURNEOCIS INCPLV2025-12-01
00810004900714Yomi S YomiLink Arch LRULNEOCIS INCPLV2025-12-01
00810004900721Yomi S YomiLink Teeth Anterior LLURNEOCIS INCPLV2025-12-01
00810004900738Yomi S YomiLink Teeth Anterior LRULNEOCIS INCPLV2025-12-01
00810004900745Yomi S YomiLink Bone Lower LLNEOCIS INCPLV2025-12-01
00810004900752Yomi S YomiLink Bone Lower LRNEOCIS INCPLV2025-12-01
00810004900769Yomi S YomiLink Bone Upper ULNEOCIS INCPLV2025-12-01
00810004900776Yomi S YomiLink Bone (U) Assembly (UR)NEOCIS INCPLV2025-12-01
00810004900783Yomi S Tracker End Effector AssemblyNEOCIS INCPLV2025-12-01
00810004900790Yomi S YomiLink-TEE ScrewNEOCIS INCPLV2025-12-01
00810004900806Yomi S TEE Flange ScrewNEOCIS INCPLV2025-12-01
00810004900813Yomi S Fiducial Array ScrewNEOCIS INCPLV2025-12-01
00810004900820Yomi S Draping KitNEOCIS INCPLV2025-12-01
00810004900837Yomi S Robotic SystemNEOCIS INCPLV2025-12-01
00810004900844Yomi S Starter KitNEOCIS INCPLV2025-12-01
00817421022920X-GuideXNAV TECHNOLOGIES LLCPLV2024-12-09
00817421023361X-GuideXNAV TECHNOLOGIES LLCPLV2024-12-09
00817421022791X-GuideXNAV TECHNOLOGIES LLCPLV2024-10-08
00817421022784X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022814X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022821X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-06
00817421022753X-GuideXNAV TECHNOLOGIES LLCPLV2024-09-05
00810004900578YLB-IOFA- LargeNEOCIS INCPLV2024-09-05