FDA.reportPublic FDA data

DM

Primary DI
16975384336056
Brand
DM
Company
Guilin Kevin Peter Technology Co., Ltd.
Model
KP-3504-21
Device description
5 pieces
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16975384336056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697538433605616975384336056

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. 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 a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
621948840
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975384334857KPKP-12vt-21-T2025-12-31
06975384334345KPKP-16vt-252025-12-30
06975384334352KPKP-16vt-312025-12-30
06975384334369KPKP-2004-212025-12-30
06975384334376KPKP-2004-252025-12-30
06975384334383KPKP-2004-312025-12-30
06975384334390KPKP-2504-212025-12-30
06975384334406KPKP-2504-252025-12-30
06975384334413KPKP-2504-312025-12-30
06975384334420KPKP-2506-212025-12-30
06975384334437KPKP-2506-252025-12-30
06975384334444KPKP-2506-312025-12-30
06975384334451KPKP-3004-212025-12-30
06975384334468KPKP-3004-252025-12-30
06975384334475KPKP-3004-312025-12-30
06975384334482KPKP-3504-212025-12-30
06975384334499KPKP-3504-252025-12-30
06975384334505KPKP-3504-312025-12-30
06975384334581KPKP-12vt-212025-12-30
06975384334598KPKP-12vt-252025-12-30

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