FDA.reportPublic FDA data

3D Endo

Primary DI
00810126501554
Brand
3D Endo
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
KN2108
Catalog number
KN2108
Device description
K-File NiTi 21mm #08 6/Pk
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00810126501554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126501554008101265015548101265015540810126501554

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080194935
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830090EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830106EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830113EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03