FDA.reportPublic FDA data

Implant Prosthetics

Primary DI
00842092117217
Brand
Implant Prosthetics
Company
Preat Corporation
Model
8001650
Catalog number
8001650
Device description
3i Certain 3.4mm/4.1mm/5mm/6mm Titanium Screw
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092117217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092117217008420921172178420921172170842092117217

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092170199Preat9001230-109001230-102026-06-09
00842092174999Preat9003731-1009003731-1002026-06-09
00842092187722Preat7100033-27100033-22026-06-08
00842092116906Implant Prosthetics800125080012502016-09-16
00842092117491Implant Prosthetics800055080005502016-09-16
00842092110669FR Attachments070204007020402023-07-05
00842092112076Preat06000F906000F92022-10-25
00842092112113Preat Implant Prosthetics0600F130600F132023-07-03
00842092122396Preat Implant Prosthetics800123780012372022-11-22
00842092155844Implantlink090751009075102022-10-25
00842092167601Preat0600F160600F162022-10-25
00842092167618Preat060406606040662022-10-25
00842092172544Preat010900301090032022-10-24
00842092172551Preat010900501090052022-10-24
00842092175590Preat010200701020072022-10-25
00842092175606Preat010200801020082022-10-25
00842092176696Preci-Clix01004TI01004TI2022-10-27
00842092110577Mays020006002000602023-10-17
00842092110737Splintastik020000102000012023-10-17
00842092109281Preci 52010156101015612023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
08800292991923Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991930Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03