FDA.report

3D Endo

Primary DI
00810126501028
Brand
3D Endo
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
HS2525
Catalog number
HS2525
Device description
Hedstrom Files SS 25mm #25 6/Pk
Published
2023-02-20
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
true

Related Records

Contact Domains

Product Codes

CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810126501028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126501028008101265010288101265010280810126501028

GMDN Terms

TermDefinition
Manual endodontic file/rasp, single-useA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as an endodontic reamer. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)605-8061cs@3d-dent.com

Regulatory Flags

DUNS number
080194935
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16
00810126508201Essentials By 3D DentalPTC-Y2026-03-12
008171690293113D DentalKF21082026-03-12
00810126508218Essentials By 3D DentalPBBT-1002026-03-11
00810126508225Essentials By 3D DentalPBBT-202026-03-11
00810126508232Basik by 3D DentalBPGC345T2026-03-11
00810126508249Basik by 3D DentalBPGC316T2026-03-11
00810126508256Basik by 3D DentalBPGC304T2026-03-11
00810126508263Basik by 3D DentalBPGC303T2026-03-11

Other Devices Sharing Product Codes

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