FDA.reportPublic FDA data

Preat

Primary DI
00842092172193
Brand
Preat
Company
Implants and Attachments, Inc.
Model
0600F16
Catalog number
0600F16
Device description
F16 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
00842092170045PackageGS16In Commercial Distribution
00842092172193PackageGS110In Commercial Distribution
00842092172209PackageGS1125In Commercial Distribution
00842092172216PackageGS125In Commercial Distribution
00842092167601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092170045008420921700458420921700450842092170045
00842092172193008420921721938420921721930842092172193
00842092172209008420921722098420921722090842092172209
00842092172216008420921722168420921722160842092172216
00842092167601008420921676018420921676010842092167601

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
00887919170488Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
07908611200822TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJL2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
EMICCPF10071Ena PostMICERIUM SPAEJL2023-05-03
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08