NobelBiocare™ 8000530

GUDID 00842092162446

NobelBiocare™ Tri-Lobe-compatible RP Engaging Verification Cylinder

Preat Corporation

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00842092162446
NIH Device Record Keybc494ac4-398b-411b-a25a-400769609ac2
Commercial Distribution StatusIn Commercial Distribution
Brand NameNobelBiocare™
Version Model Number8000530
Catalog Number8000530
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
Phone+1 (800) 232-7732
Emailinfo@preat.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092101032 [Primary]
GS100842092162446 [Package]
Contains: 00842092101032
Package: Pack [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

[00842092162446]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-10
Device Publish Date2023-08-02

Devices Manufactured by Preat Corporation

00842092182208 - Preat2024-04-17 ASC Zimmer® TSV-compatible 5.7mm Engaging Titanium Base
00842092182215 - Preat2024-04-17 ASC Zimmer® TSV WP Non-Engaging Titanium Base
00842092182222 - Preat2024-04-17 ASC Biomet 3i Certain®-compatible 3.4mm Non-Engaging Titanium Base
00842092182239 - Preat2024-04-17 NobelBiocare™ Tri-Lobe-compatible 6.0mm Engaging Verification Cylinder
00842092182246 - Preat2024-04-17 NobelBiocare™ Tri-Lobe-compatible 6.0mm Non-Engaging Verification Cylinder
00842092182185 - Equator2024-04-16 Equator Abutment for Astra EV 5.4 x 5mm
00842092182192 - Equator2024-04-16 Equator Abutment for Astra EV 5.4 x 6mm
00842092182154 - Equator2024-02-19 Equator Abutment for Astra Aqua 3.5/4.0 x 4mm
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