FDA.report

Neodent

Primary DI
07899878018407
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
191.045
Catalog number
191.045
Device description
NEODENT DIGITAL SINGLE UNIT
Published
2016-04-21
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
true

Related Records

Contact Domains

Product Codes

CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878018407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878018407078998780184077899878018407

GMDN Terms

TermDefinition
Dental bridge, ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

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
false
Premarket exempt
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07899878068372Neodent116.305116.3052026-01-22
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07899878057024Neodent106.273106.2732023-07-13
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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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Primary DIBrandCompanyProduct codePublished
00840481138218LOCATOR FixedZest Anchors, LLCNHA2026-05-22
00840481138225LOCATOR FixedZest Anchors, LLCNHA2026-05-22
00840481138232LOCATOR FixedZest Anchors, LLCNHA2026-05-22
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07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482524IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120482579IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486621NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486775NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486829NP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487079RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487383NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487437RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487482RP Straight Anatomic Abutment 5.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120487536NP Straight Anatomic Abutment 3.0mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487628IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487727IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120487826IH Straight Curve Concave Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120488328IH Straight Anatomic Abutment 3.75mm diameterSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24