FDA.reportPublic FDA data

Z-Plugger 35/70

Primary DI
00810092938767
Brand
Z-Plugger 35/70
Company
NUSMILE, LTD.
Model
UDPL357001
Device description
1 unit
Published
2022-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00810092938767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810092938767008100929387678100929387670810092938767

GMDN Terms#

Term, Definition table
TermDefinition
Manual non-rotary dental instrument handleA hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags#

DUNS number
185497372
Device count
1
DM exempt
true
Premarket exempt
true
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
00810118103650Zarc by Avalon Biomed Gutta Perch Obturator (Pellets)63440032026-01-15
00810118105555Ultradent MTApex 5.0 g Powder138692026-01-14
00810118105562Ultradent MTApex 5.0 ml Gel138682026-01-14
00810118106620EdgeEndo Biocermaic Sealer TipNEOPROT2026-01-14
00810118106637Dentsply ProRoot Flex TipPRFT202026-01-14
00810118106644NuSmile ReVIVE CrownsSK704L2025-11-26
00810118106651NuSmile ReVIVE CrownsPK704L2025-11-26
00810118106682NuSmile ReVIVE CrownsPK706L2025-11-26
00810118106842NuSmile ReVIVE CrownsLC1704L2025-11-26
00810118106859NuSmile ReVIVE CrownsLC2704L2025-11-26
00810118106866NuSmile ReVIVE CrownsLC3704L2025-11-26
00810118106873NuSmile ReVIVE CrownsLC4704L2025-11-26
00810118106880NuSmile ReVIVE CrownsLC5704L2025-11-26
00810118106897NuSmile ReVIVE CrownsU1704L2025-11-26
00810118106903NuSmile ReVIVE CrownsU2704L2025-11-26
00810118106910NuSmile ReVIVE CrownsU3704L2025-11-26
00810118106927NuSmile ReVIVE CrownsU4704L2025-11-26
00810118106934NuSmile ReVIVE CrownsDLL1706L2025-11-26
00810118106941NuSmile ReVIVE CrownsDLL2706L2025-11-26
00810118106958NuSmile ReVIVE CrownsDLL3706L2025-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830076EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
06941877830083EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
80810213810008EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810015EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810022EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810039EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810046EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810060EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810084EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810091EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810107EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810114EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810121EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810138EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810145EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810152EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810169EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810176EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810183EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810190EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810206EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810213EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810220EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810237EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810244EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810251EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810268EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23