FDA.report

DENTECH

Primary DI
04560218662811
Brand
DENTECH
Company
DENTECH CORPORATION
Model
02312200
Device description
M Peeso Reamer CA #000 (set of 4 pcs)
Published
2020-09-24
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
false

Related Records

Product Codes

CodeName
DZADrill, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560218662811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560218662811045602186628114560218662811

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
700723000
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
false
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
04560218676818DENTECH300147422024-01-17
04560218669773DENTECH010149992022-08-26
04560218660718DENTECH500300002021-09-30
04560218660442DENTECH010182122020-09-24
04560218660589DENTECH507106002020-09-24
04560218660596DENTECH507107002020-09-24
04560218667120DENTECH061221002020-09-24
04560218667243DENTECH063010102020-09-24
04560218667489DENTECH070001002020-09-24
04560218667496DENTECH070001012020-09-24
04560218667502DENTECH070001022020-09-24
04560218667519DENTECH070001032020-09-24
04560218667533DENTECH070001052020-09-24
04560218667540DENTECH070001062020-09-24
04560218668493DENTECH070001502020-09-24
04560218669377DENTECH010182132020-09-24
04560218669452DENTECH010149022020-09-24
04560218669469DENTECH010149032020-09-24
04560218669476DENTECH010149072020-09-24
04560218669483DENTECH010149082020-09-24

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08800341415226Final DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
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