FDA.report

Nuvo

Primary DI
07899878050636
Brand
Nuvo
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
CD2818013
Catalog number
CD2818013
Device description
ANGLE MEASURER 17D CF
Published
2022-12-08
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
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878050636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878050636078998780506367899878050636

GMDN Terms

TermDefinition
Dental implantation depth/angle gauge, reusableA device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. 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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07899878057192Neodent102.246102.2462023-07-13
07899878057208Neodent102.247102.2472023-07-13

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