FDA.reportPublic FDA data

InnerView® System Smart Tips

Primary DI
00860011518327
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
036802075
Device count
24
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011518324InnerView® System Disposable Tips INV-3000INV-30002025-03-05
00860011518334InnerView® 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