FDA.reportPublic FDA data

Preat

Primary DI
00842092171950
Brand
Preat
Company
Implants and Attachments, Inc.
Model
06000F9
Catalog number
06000F9
Device description
F9 Silicone Cutters
Published
2022-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental
NDPAccessories, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092171950PackageGS110In Commercial Distribution
00842092171967PackageGS1125In Commercial Distribution
00842092171974PackageGS125In Commercial Distribution
00842092171981PackageGS16In Commercial Distribution
00842092112076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092171950008420921719508420921719500842092171950
00842092171967008420921719678420921719670842092171967
00842092171974008420921719748420921719740842092171974
00842092171981008420921719818420921719810842092171981
00842092112076008420921120768420921120760842092112076

GMDN Terms#

Term, Definition table
TermDefinition
Dental precision attachment fitting/adjustment toolA manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054875224
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092101063NobelBiocare™ Tri-Lobe-compatible 800055180005512023-08-10
00842092177105Preat Implant Prosthetics900373290037322022-11-03
00842092161708Preat Implant Prosthetics900475090047502022-11-03
00842092161784Preat Implant Prosthetics900703090070302022-11-03
00842092161814Preat Implant Prosthetics900723090072302022-11-03
00842092161845Preat Implant Prosthetics900703590070352022-11-03
00842092161876Preat Implant Prosthetics900723590072352022-11-03
00842092157169Preat Implant Prosthetics900643090064302022-10-31
00842092157213Preat Implant Prosthetics900653090065302022-10-31
00842092159132Preat Implant Prosthetics900665090066502022-10-31
00842092157268Preat Implant Prosthetics900663090066302022-10-31
00842092159149Preat Implant Prosthetics900675090067502022-10-31
00842092157312Preat Implant Prosthetics900673090067302022-10-31
00842092157350Preat Implant Prosthetics900683090068302022-10-31
00842092157381Preat Implant Prosthetics900643590064352022-10-31
00842092157411Preat Implant Prosthetics900653590065352022-10-31
00842092157442Preat Implant Prosthetics900663590066352022-10-31
00842092157473Preat Implant Prosthetics900673590067352022-10-31
00842092157503Preat Implant Prosthetics900683590068352022-10-31
00842092159576Preat Implant Prosthetics900583090058302022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
00887919673866Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
00887919676201Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
00887919752301Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
00887919752332Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
00887919773689Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
00887919813170Brasseler USAPeter Brasseler Holdings, LLCEJL2023-01-25
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14