FDA.report

Neodent

Primary DI
07899878029137
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
103.426
Catalog number
103.426
Device description
DRILL EXTENSION
Published
2022-12-12
Public version status
Update
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
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878029137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878029137078998780291377899878029137

GMDN Terms

TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from Sunlight
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
906713888
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07899878057079Neodent118.386118.3862023-07-13
07899878057109Neodent135.424-ET135.424-ET2023-07-13
07899878057116Neodent135.425-ET135.425-ET2023-07-13
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

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