FDA.reportPublic FDA data

M-Tip

Primary DI
04560205919010
Brand
M-Tip
Company
MICRON CO.,LTD.
Model
L16
Published
2023-07-01
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560205919010PrimaryGS10
04560205919034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560205919010045602059190104560205919010
04560205919034045602059190344560205919034

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement system handpiece tip, endodontic, reusableA removable endpiece intended to be attached to a pneumatic dental scaling/debridement system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to fragment/remove tissue during an endodontic procedure. It is available variety of forms and sizes, and is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
692731615
Device count
10
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560205916569AW-100AW-100-KA2023-07-01
04560205916576AW-100AW-100-4H2023-07-01
04560205919027M-TipL202023-07-01
04560205916859TA-200TA-200-S4H2023-07-01
04560205916866TA-200TA-200-S2H2023-07-01
04560205917122TA-100TA-100-4H2023-07-01
04560205917139TA-100TA-100-2H2023-07-01
04560205917351YU-100YU-100-K2023-07-01
04560205917368YU-100YU-100-N2023-07-01
04560205917375YU-100YU-100-S2023-07-01
04560205917382YU-100YU-100-4H2023-07-01
04560205919041M-TipL202023-07-01
04560205919058MICRON SYRINGEMICRON SYRINGE2023-07-01
04560205914084SS17KSS17K-K2022-12-22
04560205914091SS17KSS17K-M2022-12-22
04560205914107SS17KSS17K-B2022-12-22
04560205914206POLISH PLUSPPW-W2022-12-22
04560205914213POLISH PLUSPPW-S2022-12-22
04560205914220POLISH PLUSPPW-B2022-12-22
04560205914237POLISH PLUSPPW-N2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24