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
00858466005257ENDOMAXDENTAMERICA, INC.EKX2026-04-22
00858466005240ENDOMAXDENTAMERICA, INC.EKX2026-04-21
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
10194665008529A-decA-DEC, INC.EKX2026-02-19
10194665008550A-decA-DEC, INC.EKX2026-02-19
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09010522002537SmartPeg Type 137Osstell ABEKX2026-02-09
D100B00XSGO000000X-Smart Go Cordless endo motor with integrated apex locatorFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0006X-Smart® Go Contra-angle (6:1)FORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100B00XSGOAC0007X-Smart® Go Protective silicone sleeveFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
D100BSPXSGOAC0005X-Smart® Go Power bankFORUM ENGINEERING TECHNOLOGIES (96) LTD.EKX2026-01-23
09010522002674MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
09010522002575Osstell SmartPeg Type 113Osstell ABEKX2025-03-27
09010522002599Osstell SmartPeg Type 114Osstell ABEKX2025-03-27
09010522002612Osstell SmartPeg Type 115Osstell ABEKX2025-03-27
E27667790160X-Smart ProSIRONA Dental Systems GmbHEKX2024-07-29
09010522002483SmartPeg Type 117Osstell ABEKX2024-05-15