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
00842092110591Universal IC Attachment120011212001122022-10-28
00842092174432Preat Implant Prosthetics1500150P1500150P2022-10-28
00842092161470Preat Implant Prosthetics900477790047772022-11-03
00842092161487Preat Implant Prosthetics900477890047782022-11-03
00842092161494Preat Implant Prosthetics900477990047792022-11-03
00842092161500Preat Implant Prosthetics900478990047892022-11-03
00842092161524Preat Implant Prosthetics900478090047802022-11-03
00842092161548Preat Implant Prosthetics900478190047812022-11-03
00842092161562Preat Implant Prosthetics1604701C1604701C2022-11-03
00842092161586Preat Implant Prosthetics1604702C1604702C2022-11-03
00842092161609Preat Implant Prosthetics1604703C1604703C2022-11-03
00842092161623Preat Implant Prosthetics1604704C1604704C2022-11-03
00842092161708Preat Implant Prosthetics900475090047502022-11-03
00842092161654Preat Implant Prosthetics900476190047612022-11-03
00842092161678Preat Implant Prosthetics900476290047622022-11-03
00842092161692Preat Implant Prosthetics900475990047592022-11-03
00842092161715Preat Implant Prosthetics900472190047212022-11-03
00842092161722Preat Implant Prosthetics900472290047222022-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26