FDA.reportPublic FDA data

InnerView® System Smart Tips

Primary DI
00860011518334
Brand
InnerView® System Smart Tips
Company
Perimetrics, Inc.
Model
INV-3000
Catalog number
INV-3000
Device description
Non-sterile, single-use disposable tips intended for use with InnerView System Handpiece.
Published
2025-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKXHandpiece, Direct Drive, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232657000InnerView LCPerimetrics, Inc.2023-09-01EKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011518334PrimaryGS10
00860011518327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011518334008600115183348600115183340860011518334
00860011518327008600115183278600115183270860011518327

GMDN Terms#

Term, Definition table
TermDefinition
Dental stability percussive analysis handpiece coverA device in the form of a thin lid intended to be used as a physical barrier between the patient and the tip of a dental stability percussive analysis handpiece to prevent cross-contamination between patients. It may incorporate a non-powered microchip with a unique security code intended to be read by the handpiece to verify it has not been reused. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-888-325-7218xx@xx.xx

Regulatory Flags#

DUNS number
036802075
Device count
24
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011518324InnerView® System Disposable Tips INV-3000INV-30002025-03-05
00860011518327InnerView® System Smart Tips INV-3000INV-30002025-07-31
00860011518303InnerView® System Handpiece INV-1000INV-10002025-03-05
00860011518310 InnerView® System Base StationINV-2000INV-20002025-03-05
10086001151832InnerView® System Disposable Tips INV-3000INV-30002025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230017ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230024ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230031ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230048ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230055ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313230062ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237429ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237436ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237443ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237450ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237467ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237474ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237481ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237498ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
08800313237504ChecQPEGDENTIS CO. ,LTDEKX2026-08-26
06944843655932COLTENEGuilin Woodpecker Medical Instrument Co., Ltd.EKX2026-08-18
10817417020227AsepticoASEPTICO, INC.EKX2026-04-08
10817417020326AsepticoASEPTICO, INC.EKX2026-04-08
10817417020371AsepticoASEPTICO, INC.EKX2026-04-06
10817417020388AsepticoASEPTICO, INC.EKX2026-04-06
10817417020418AsepticoASEPTICO, INC.EKX2026-04-03
10817417020425AsepticoASEPTICO, INC.EKX2026-04-03
10817417020432AsepticoASEPTICO, INC.EKX2026-04-03
10817417020449AsepticoASEPTICO, INC.EKX2026-04-03
08809260475458E-CUBESaeshin Precision Co., Ltd.EKX2026-03-31
10194665008475A-decA-DEC, INC.EKX2026-02-19
10194665008482A-decA-DEC, INC.EKX2026-02-19
10194665008499A-decA-DEC, INC.EKX2026-02-19
10194665008505A-decA-DEC, INC.EKX2026-02-19
10194665008512A-decA-DEC, INC.EKX2026-02-19