FDA.report

Polygon Drill # 1

Primary DI
08059388440375
Brand
Polygon Drill # 1
Company
OVERFIBERS SRL
Model
Polygon Drill # 1
Catalog number
PYD01
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08059388440375PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
431704826
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08059388443307NeobondNeobondDPNEO12025-08-26
08059388442911Prosthetic Over Post # 0Prosthetic Over Post # 0POP1002025-03-12
08059388442928Prosthetic Over Post # 1Prosthetic Over Post # 1POP1012025-03-12
08059388442935Prosthetic Over Post # 2Prosthetic Over Post # 2POP1022025-03-12
08059388442942Prosthetic Over Post # 3Prosthetic Over Post # 3POP1032025-03-12
08059388442959Prosthetic Over Post # 4Prosthetic Over Post # 4POP1042025-03-12
08059388443215Over Post+ # 0Over Post+ # 0PP7002025-03-12
08059388443222Over Post+ # 1Over Post+ # 1PP7012025-03-12
08059388443239Over Post+ # 2Over Post+ # 2PP7022025-03-12
08059388443246Over Post+ # 3Over Post+ # 3PP7032025-03-12
08059388443253Over Post+ # 4Over Post+ # 4PP7042025-03-12
08059388442966Endodontic Over Post # 0Endodontic Over Post # 0EOP2002025-03-12
08059388442973Endodontic Over Post # 1Endodontic Over Post # 1EOP2012025-03-12
08059388442980Endodontic Over Post # 2Endodontic Over Post # 2EOP2022025-03-12
08059388442997Endodontic Over Post # 3Endodontic Over Post # 3EOP2032025-03-12
08059388443000Endodontic Over Post # 4Endodontic Over Post # 4EOP2042025-03-12
08059388443017Duo Over Post # 1Duo Over Post # 1DOP3012025-03-12
08059388443024Duo Over Post # 2Duo Over Post # 2DOP3022025-03-12
08059388442881Polygon Over Post # 1Polygon Over Post # 1PYOP012025-03-12
08059388442898Polygon Over Post # 2Polygon Over Post # 2PYOP022025-03-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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08800341415165Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415172Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415189Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415196Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415202Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415219Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415233Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415240Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415257Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415264Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800341415271Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
08800055792163Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792170Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
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