FDA.reportPublic FDA data

IDS Insight Dental Implant System

Primary DI
00855992007298
Brand
IDS Insight Dental Implant System
Company
TITAN IMPLANT SYSTEMS, LLC
Model
381012
Device description
3.8x12mm Bone Level Screw-Retained Finished System
Published
2018-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NDPAccessories, Implant, Dental, Endosseous
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855992007298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855992007298008559920072988559920072980855992007298

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length12Millimeter
Width3.8Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-982-1511heather@insightdentalsystems.com

Regulatory Flags#

DUNS number
080676194
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855992007007IDS Insight Dental Implant System3500082017-08-09
00855992007014IDS Insight Dental Implant System3500102017-08-09
00855992007021IDS Insight Dental Implant System3500122017-08-09
00855992007038IDS Insight Dental Implant System3800082017-08-09
00855992007045IDS Insight Dental Implant System3800102017-08-09
00855992007052IDS Insight Dental Implant System3800122017-08-09
00855992007069IDS Insight Dental Implant System4600082017-08-09
00855992007076IDS Insight Dental Implant System4600102017-08-09
00855992007083IDS Insight Dental Implant System4600122017-08-09
00855992007090IDS Insight Dental Implant System5400082017-08-09
00855992007106IDS Insight Dental Implant System5400102017-08-09
00855992007113IDS Insight Dental Implant System5400122017-08-09
00855992007120IDS Insight Dental Implant System3501082017-08-09
00855992007137IDS Insight Dental Implant System3501102017-08-09
00855992007144IDS Insight Dental Implant System3501122017-08-09
00855992007151IDS Insight Dental Implant System3801082017-08-09
00855992007168IDS Insight Dental Implant System3801102017-08-09
00855992007175IDS Insight Dental Implant System3801122017-08-09
00855992007182IDS Insight Dental Implant System4601082017-08-09
00855992007199IDS Insight Dental Implant System4601102017-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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