Sphero Flex 0828682

GUDID 00842092181430

Sphero Flex Abutment Branemark RP x 2mm

Preat Corporation

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID00842092181430
NIH Device Record Key131fc94f-5471-4f20-80a7-444a12b8b9f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSphero Flex
Version Model Number0828682
Catalog Number0828682
Company DUNS117776048
Company NamePreat Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092181430 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


[00842092181430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-23
Device Publish Date2023-08-15

On-Brand Devices [Sphero Flex]

00842092165195Sphero Flex Abutment Nobel Active/Conical NP x 1mm
00842092181430Sphero Flex Abutment Branemark RP x 2mm
00842092181423Sphero Flex Abutment Branemark RP x 1mm
00842092181768Sphero Flex Abutment Calcitek Integral 3.25 x 2mm (2.5mm Ball)
00842092181751Sphero Flex Abutment Calcitek Integral 3.25 x 4mm (2.5mm Ball)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.