FDA.reportPublic FDA data

IDS Insight Dental Implant System

Primary DI
00855992007007
Brand
IDS Insight Dental Implant System
Company
TITAN IMPLANT SYSTEMS, LLC
Model
350008
Device description
3.5x8mm Bone Level Finished System
Published
2017-08-09
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
00855992007007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855992007007008559920070078559920070070855992007007

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
Length8Millimeter
Width3.5Millimeter

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
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
00855992007205IDS Insight Dental Implant System4601122017-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20