FDA.reportPublic FDA data

American Dental Implant

Primary DI
D896IC570
Brand
American Dental Implant
Company
AMERICAN DENTAL IMPLANT CORPORATION
Model
IC57
Catalog number
IC57
Device description
"5.7mm Hexed Closed Tray Impression Coping w/ .050"" Screw"
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D896IC570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8005110661info@americandentalimplant.com

Regulatory Flags#

DUNS number
835556429
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8963250115SD0American Dental Implant3250115SD3250115SD2024-04-10
D896325010SD0American Dental Implant325010SD325010SD2024-04-10
D896325013SD0American Dental Implant325013SD325013SD2024-04-10
D896325015SD0American Dental Implant325015SD325015SD2024-04-10
D8964DTW200American Dental Implant4DTW204DTW202018-07-31
D8964DTW300American Dental Implant4DTW304DTW302018-07-31
D8963ASAB0American Dental Implant3AS-AB3AS-AB2019-02-18
D8963ASB0American Dental Implant3AS-B3AS-B2019-02-18
D8963AS0American Dental Implant3AS3AS2018-07-31
D896AS0American Dental ImplantASAS2018-07-31
D896ASA0American Dental ImplantAS-AAS-A2018-07-31
D896ASAG0American Dental ImplantAS-AGAS-AG2018-07-31
D896ASAP0American Dental ImplantAS-APAS-AP2018-07-31
D896ASG0American Dental ImplantAS-GAS-G2018-07-31
D896ASP0American Dental ImplantAS-PAS-P2018-07-31
D896ASY0American Dental ImplantAS-YAS-Y2018-07-31
D896ADTD200American Dental Implant ADTD20ADTD202018-07-31
D896ADTD20S0American Dental Implant ADTD20SADTD20S2018-07-31
D896ADTD230American Dental Implant ADTD23ADTD232018-07-31
D896ADTD23S0American Dental Implant ADTD23SADTD23S2018-07-31

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