Nobel Active 8004730

GUDID 00842092163054

Nobel Active/Conical 3.0mm Engaging Verification Cylinder Kit contains: 1 Nobel Active/Conical 3.0mm Engaging Verification Cylinder (00842092114377) 1 Nobel Active/Conical 3.0mm Guide Pin 20mm (00842092114407) 1 Nobel Active/Conical 3.0mm Titanium Screw (00842092117583)

PREAT CORPORATION

Dental implant suprastructure, temporary, preformed, single-use

Primary Device ID	00842092163054
NIH Device Record Key	1d0b26b5-54c1-4f0e-95c6-412126e0ac29
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nobel Active
Version Model Number	8004730
Catalog Number	8004730
Company DUNS	054875224
Company Name	PREAT CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842092163054 [Package] Contains: 00842092168189 Package: [10 Units] In Commercial Distribution
GS1	00842092163061 [Package] Contains: 00842092168189 Package: [25 Units] In Commercial Distribution
GS1	00842092168189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142118

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-16
Device Publish Date	2022-09-08

On-Brand Devices [Nobel Active]

00842092163054	Nobel Active/Conical 3.0mm Engaging Verification Cylinder Kit contains: 1 Nobel Active/Conical 3
00842092180044	Nobel Active/Conical WP Non-Engaging Verification Cylinder
00842092180020	Nobel Active/Conical WP Engaging Verification Cylinder

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