FDA.report

Nuvo

Primary DI
07899878058618
Brand
Nuvo
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
CD3033001
Catalog number
CD3033001
Device description
TREPHINE BUR
Published
2023-08-10
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

Contact Domains

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878058618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878058618078998780586187899878058618

GMDN Terms

TermDefinition
Dental implant reamerA surgical tool designed to over-drill a dental implant to facilitate its removal by excising bone in which it is implanted. It is in the form of a hollow fluted metal shaft, with saw teeth at the cutting edge, available in a variety of sizes to match different implant sizes; it is typically supplied with a drill guide. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter3.5Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags

DUNS number
906713888
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07899878057123Neodent135.426-ET135.426-ET2023-07-13
07899878057130Neodent135.427-ET135.427-ET2023-07-13
07899878057147Neodent135.428-ET135.428-ET2023-07-13
07899878057154Neodent135.429-ET135.429-ET2023-07-13
07899878057161Neodent135.430-ET135.430-ET2023-07-13
07899878057178Neodent135.431-ET135.431-ET2023-07-13
07899878057185Neodent102.245102.2452023-07-13
07899878057192Neodent102.246102.2462023-07-13
07899878057208Neodent102.247102.2472023-07-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800341415158First DrillARUM DENTISTRY Co., Ltd.DZA2026-03-24
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
08800055792187Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792194Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792200Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792217Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792224Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792231Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792248Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792255Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792262Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792279Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792286Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792293Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792309Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792316Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20
08800055792323Step DrillARUM DENTISTRY Co., Ltd.DZA2026-03-20