FDA.reportPublic FDA data

H-Endodontic Drill # 2

Primary DI
08059388442782
Brand
H-Endodontic Drill # 2
Company
OVERFIBERS SRL
Model
H-Endodontic Drill # 2
Catalog number
HED202
Published
2025-02-21
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059388442782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059388442782080593884427828059388442782

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
431704826
Device count
1
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
08059388443307NeobondNeobondDPNEO12025-08-26
08059388441167Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388441174Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388441181Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388441198Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388441204Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388441211Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388441228Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388441235Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388441242Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388441259Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388441365Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388441372Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388441389Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388441396Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388441402Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388441518Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388441525Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388441556Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388441563Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290108819120Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819137Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819144Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819151Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819168Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290108819175Dental DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150147EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150178EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150185EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150192EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150208EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150215EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150222EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150239EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150246EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150253EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150260EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116150277EZguide Stop DrillNORIS MEDICAL LTDDZA2026-08-18
07290116155623Diamond BurrNORIS MEDICAL LTDDZA2026-08-17
00840456224496JMUJMU DENTAL, INCDZA2026-07-29
00840456224502JMUJMU DENTAL, INCDZA2026-07-29
00840456224519JMUJMU DENTAL, INCDZA2026-07-29
00840456224526JMUJMU DENTAL, INCDZA2026-07-29
00840456224533JMUJMU DENTAL, INCDZA2026-07-29
00840456224540JMUJMU DENTAL, INCDZA2026-07-29
00840456224557JMUJMU DENTAL, INCDZA2026-07-29
00840456224564JMUJMU DENTAL, INCDZA2026-07-29
08806343926302Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926319Sinus KitShinhung MST Co., Ltd.DZA2026-07-29
08806343926326Sinus KitShinhung MST Co., Ltd.DZA2026-07-29