FDA.reportPublic FDA data

O Rings for Yomi S TEE Screw Bag of 25

Primary DI
00810004900851
Brand
O Rings for Yomi S TEE Screw Bag of 25
Company
NEOCIS INC
Model
DRW-3848-00
Device description
O Rings for Yomi S TEE Screw
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
00810004900851PrimaryGS10
00810004900868Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004900851008100049008518100049008510810004900851
00810004900868008100049008688100049008680810004900868

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
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00810004900677Yomi S Intra Oral Fiducial Array LargeDRW-2823-032025-12-01
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
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
00810004900677Yomi S Intra Oral Fiducial Array LargeNEOCIS 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