FDA.reportPublic FDA data

Neodent

Primary DI
07899878065760
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
191.099
Catalog number
191.099
Device description
CUSTOM ABUTMENT ANGLED SOLUTION TI, FOR NEODENT HS. TI SCREW
Published
2025-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250614000Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.2025-05-27NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899878065760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899878065760078998780657607899878065760

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags#

DUNS number
906713888
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899878068181Neodent118.413118.4132026-09-25
07899878068198Neodent118.414118.4142026-09-25
07899878068211Neodent138.196138.1962026-09-25
07899878068228Neodent138.197138.1972026-09-25
07899878068235Neodent116.309116.3092026-09-25
07899878068242Neodent116.308116.3082026-09-25
07899878068259Neodent118.415118.4152026-09-25
07899878068266Neodent104.075104.0752026-09-25
07899878068273Neodent104.078104.0782026-09-25
07899878068280Neodent104.076104.0762026-09-25
07899878068297Neodent104.077104.0772026-09-25
07899878066989Neodent106.281106.2812026-07-03
07899878066996Neodent106.282106.2822026-07-03
07899878067009Neodent106.283106.2832026-07-03
07899878067016Neodent106.284106.2842026-07-03
07899878067023Neodent106.285106.2852026-07-03
07899878067030Neodent106.286106.2862026-07-03
07899878067047Neodent106.287106.2872026-07-03
07899878067054Neodent106.288106.2882026-07-03
07899878067061Neodent106.289106.2892026-07-03

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Primary DI, Brand, Company table
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05712821014931Elos Accurate Hybrid Base G Non-EngagingElos Medtech Pinol A/SNHA2026-10-06
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